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47 clinical studies listed.

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Addiction

Tundra lists 47 Addiction clinical trials. Each listing includes eligibility criteria, study locations, and direct links to research sites in the Tundra directory.

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COMPLETED

NCT07573345

Pain and Upper Extremity Function in Smartphone and Digital Game Addiction

With the expansion of technology-based applications, daily phone use has increased significantly. According to a 2020 study, phone use habits among young adults aged 18-34 increased by 38.1%, and the time spent on the phone exceeding one hour increased by 68%. Currently, there is no clear definition of smartphone "addiction" or smartphone use, but like other types of addiction, it refers to the effort to control smartphone habits that cause problems or distress in daily life. Recent studies have reported a correlation between excessive screen use and individuals' mental and physical health. Excessive use of phones and video games causes many negative effects, including attention deficit, inability to enjoy life, hyperactivity, depression, anxiety, pain, and functional loss. Video games are a type of game played through an audiovisual device and can be story-based. While many video games improve players' critical thinking, strategic planning, and problem-solving skills, they can also cause musculoskeletal problems due to the long hours spent at the desk and the repetitive movements involved. The human spine is a kinematic chain with all joints interconnected; this means that changes in other body parts, such as the increased head tilt while texting on a smartphone, can have significant effects on the entire spine. A 2023 study showed an increase in spinal curvature, particularly in the cervical region, as smartphone use time increased. A study in Korea linked smartphone use to increased pain in the neck, wrists, hands, shoulders, and back. Another significant problem for smartphone users and video game players is "text neck," which occurs from prolonged screen time. This causes tension in the cervical spine, leading to neck pain and stiffness. Smartphone addiction leads to hand-related problems, primarily hand and wrist pain. Furthermore, excessive use of smartphones, game controllers, and joysticks can lead to repetitive strain injuries such as carpal tunnel syndrome. Prolonged phone use, repetitive movements, and uncomfortable hand positions during use cause inflammation of the muscles and tendons in the hands and wrists, leading to swelling, pain, and loss of function in these joints. Video games are played using devices such as computers, consoles, handheld computers, and smartphones. The continuous, repetitive, and uninterrupted movements performed while using these devices can lead to musculoskeletal disorders, particularly in the upper extremities. Prolonged playing of these games results in musculoskeletal problems such as carpal tunnel syndrome and tendinitis. Extensive studies have shown that individuals' pain and symptoms worsen after prolonged gaming sessions. However, to date, there has been no study comparing smartphone addicts and video game players. The aim of this research is to compare individuals with smartphone addiction, those who play video games for extended periods, and those without these habits in terms of pain, posture, and upper extremity function.

Gender: All

Ages: 18 Years - 45 Years

Updated: 2026-08-25

Addiction
ACTIVE NOT RECRUITING

NCT06015893

Semaglutide Therapy for Alcohol Reduction (STAR)

Background: Alcohol use disorder (AUD) is a problematic pattern of alcohol use accompanied by clinically significant medical consequences. Medications can help most people reduce their drinking, but the number is limited, and additional treatment options are needed. Objective: To test if a medication named Semaglutide may reduce alcohol drinking in people with AUD. Who can participate? All Adults aged 18 or older with AUD might be eligible to participate in the study. What will happen during the study? Participants will visit the National Institute on Drug Abuse (NIDA) in Baltimore once a week for about 20 weeks (5 months). Each visit will last between 2 and 6 hours depending on the tasks scheduled for that visit. Participants will be assigned by chance (like flipping a coin) to receive either Semaglutide or placebo. A placebo looks just like a real drug but contains no medicine. The study medication is given as a shot under the skin each week. Participants will undergo different tests throughout the study: They will give blood, urine, and saliva samples. They will engage in self-paced behavioral therapy on a computer. They will answer questions about their mood, diet, alcohol drinking and craving, tobacco use, etc. They will taste several sweet liquids and tell their preferences. They will sit in a bar-like room and be exposed to cues that might make them feel the urge to eat food or drink alcohol. They will wear a virtual reality headset that creates a cafeteria setting. They will walk the virtual cafeteria and choose food and drinks from a buffet. They will have a functional magnetic resonance imaging (fMRI) scan to take pictures of their brain. During the scans, participants will be shown pictures of alcohol-containing drinks, food, and other items.They will perform tasks on a computer screen. Participants will have a follow-up visit about 7 weeks after their last shot.

Gender: All

Ages: 18 Years - 110 Years

Updated: 2026-08-24

1 state

Addiction
Alcohol Use Disorder
COMPLETED

NCT07772193

Short-Term Psychodynamic Group Therapy for Problematic Pornography Use

This randomized controlled trial evaluated the effects of short-term psychodynamic group therapy for problematic pornography use in young adult men. Participants were assigned to either a psychodynamic group therapy intervention or a control condition. The intervention consisted of 16 online group therapy sessions. The study examined changes in pornography craving, emotion regulation difficulties, shame, and guilt. Assessments were conducted before and after the intervention and at follow-up.

Gender: MALE

Ages: 18 Years - 30 Years

Updated: 2026-08-21

1 state

Addiction
COMPLETED

NCT05976646

Phase Ib/2a Drug-drug Interaction Study of a Combination of 45mg Dextromethorphan With 105 mg Bupropion

The overall goal of this project is to collect initial human data on the effects of novel compounds on safety (interactions with an opioid drug, e.g., buprenorphine) and early efficacy signals (subjective effects on negative affect, craving, and opioid withdrawal) in OUD subjects currently in MOUD treatment with buprenorphine.

Gender: All

Ages: 18 Years - 65 Years

Updated: 2026-08-19

1 state

Addiction
Opioid Use
Substance Use Disorders
+1
COMPLETED

NCT05163171

Prevalence of the Victimization and the Perpetration of Intimate Partner Violence Among the Patients From Puy-de-Dôme and Paris Consulting or Being Hospitalized for Addiction Problems and Their Expectations From General Practitioners (VIA-MG)

Intimate partner violence and addictions are two frequent problematics with many consequences on health. A link between intimate partner violence and addictions has been found in many studies. Being a drug user increases the risk to be a perpetrator and also a victim of intimate partner violence. So, it is legitimate to question ourselves about the prevalence of the victims and perpetrators of intimate partner violence among the patients consulting or being hospitalized for an addiction problem. We believe that this prevalence will be high among these patients. On the other hand, the general practitioners are in first line receiving victims and perpetrators of violence and patients with addiction problems. So it is important to know the profiles of these patients and their expectations from their general practitioners.

Gender: All

Ages: 18 Years - Any

Updated: 2026-07-31

Addiction
Violence, Domestic
RECRUITING

NCT07740291

Tirzepatide Impact Assessment Study

This study examines how two different weight-loss strategies affect heart and metabolic health, as well as changes at the molecular level in the body. One group includes adults who are starting a GLP-1 receptor agonist medication (i.e., semaglutide or tirzepatide) prescribed by their own doctor for weight loss. The other group includes adults who will participate in a structured lifestyle program combining a reduced-calorie diet with increased physical activity. Both groups complete assessments at the start of the study and again after three months. At each visit, participants have their weight, body composition, blood pressure, and resting metabolic rate measured. A blood draw is collected to evaluate cholesterol, blood sugar, insulin, appetite hormones, and liver and kidney function markers, and to analyze gene activity (RNA sequencing) and metabolites, which are small molecules that reflect how the body is using energy and nutrients. Participants also complete online questionnaires about diet, disordered eating, stress, mental health, and quality of life. Those in the lifestyle group attend three individual nutrition and physical activity counseling sessions over the course of the study. The main goals of the study are (1) to determine whether GLP-1 receptor agonist medication or lifestyle changes produce greater improvements in heart and metabolic health markers over three months; (2) to examine if GLP-1 receptor agonist medication or lifestyle changes produce greater improvement in disordered eating, stress, mental health, and quality of life; (3) to investigate if GLP-1 receptor agonist medication or lifestyle changes produce greater improvement in appetite-related hormones (i.e., ghrelin, GLP-1, insulin, leptin, and peptide YY); and (4) to explore whether the two approaches cause different changes in gene expression and metabolic profiles. This is a pilot study conducted at Texas Tech University's Nutrition and Metabolic Health Initiative clinic in Lubbock, Texas. Who can participate: Adults aged 18 years and older with a BMI of 27.5 or higher who are either starting semaglutide or tirzepatide therapy for weight management or who are seeking weight management without the use of weight-loss medications. Who cannot participate: Individuals who are pregnant or lactating, have a pacemaker or internal medical device, have certain serious medical conditions (such as active cancer, uncontrolled hypertension, or severe kidney disease), have type 1 diabetes, or use insulin for type 2 diabetes.

Gender: All

Ages: 18 Years - Any

Updated: 2026-07-31

1 state

Obesity & Overweight
Cardiometabolic Health Indicators
Addiction
+2
COMPLETED

NCT07737808

EFFECTIVENESS OF SOLUTION-FOCUSED APPROACH-BASED PSYCHOEDUCATION IN INDIVIDUALS DIAGNOSED WITH SUBSTANCE USE DISORDER: A RANDOMIZED CONTROLLED TRIAL

Substance use disorder (SUD) is a chronic, relapsing psychiatric disorder characterized by compulsive substance use despite harmful physical, psychological, and social consequences. It is associated with impaired psychosocial functioning, reduced self-efficacy, decreased psychological well-being, and a high risk of relapse. Although detoxification, pharmacotherapy, and routine psychoeducation constitute the standard components of treatment, many individuals continue to experience difficulties maintaining recovery after discharge. Therefore, there is an increasing need for psychosocial interventions that strengthen personal resources, promote recovery, and improve long-term treatment outcomes. The Solution-Focused Approach (SFA) is a strengths-based therapeutic model that emphasizes individuals' existing resources, successful experiences, future goals, and problem-solving abilities rather than focusing on deficits and pathology. Instead of exploring the causes of substance use, SFA encourages individuals to identify exceptions to their problems, recognize previous successes, build hope, and develop practical solutions that support behavioral change. Previous studies have suggested that solution-focused interventions may improve self-efficacy, motivation for change, coping skills, psychological well-being, and treatment engagement. However, evidence regarding the effectiveness of structured solution-focused psychoeducation programs among individuals with substance use disorder remains limited, particularly in randomized controlled trials conducted in inpatient addiction treatment settings. The purpose of this randomized controlled trial is to evaluate the effectiveness of a structured Solution-Focused Approach-based psychoeducation program on addiction profile, self-efficacy, and psychological well-being among individuals diagnosed with substance use disorder receiving inpatient treatment. The study was conducted between February and August 2025 at the Adult Detoxification Center of a Mental Health and Neurological Diseases Training and Research Hospital in Istanbul, Türkiye. Following completion of the detoxification phase and confirmation of eligibility criteria, participants were randomly assigned to either an intervention group or a control group. A total of 60 participants completed the study, with 30 individuals allocated to each group. Participants assigned to the intervention group received routine inpatient treatment in addition to a structured seven-session Solution-Focused Approach-based psychoeducation program developed by the researcher according to the principles of solution-focused therapy. Each session lasted approximately 60 to 90 minutes and was delivered twice weekly in small groups. The intervention included group orientation, identification of personal strengths and resources, goal setting, miracle questions, exception finding, scaling questions, solution-focused brainstorming, future-oriented planning, relapse prevention strategies, and termination activities. Throughout the intervention, participants were encouraged to identify successful coping experiences, develop realistic future goals, recognize their existing strengths, and enhance confidence in their ability to maintain recovery. Participants in the control group received routine inpatient addiction treatment only. Routine treatment consisted of detoxification, pharmacotherapy, therapeutic milieu interventions, psychoeducation delivered through the national SAMBA program, physician follow-up, psychiatric nursing care, family meetings, and other standard clinical services provided by the treatment center. Outcome assessments were performed before the intervention and immediately after completion of the psychoeducation program. Data were collected using the Addiction Profile Index (BAPI), the Self-Efficacy Scale, and the Psychological Well-Being Scale. Sociodemographic and clinical characteristics were also recorded. The primary objective of this study was to determine whether solution-focused psychoeducation improves psychological well-being and self-efficacy compared with routine inpatient treatment alone. Secondary objectives included evaluating changes in addiction profile and its subdimensions, particularly craving and safe behavioral characteristics. It was hypothesized that participants receiving the Solution-Focused Approach-based psychoeducation program would demonstrate greater improvements in psychological well-being and self-efficacy, together with reductions in craving and addiction-related problems, compared with participants receiving routine treatment alone. The findings of this study are expected to contribute to the development of evidence-based psychosocial nursing interventions for individuals with substance use disorder and to support the integration of recovery-oriented psychoeducation into routine addiction treatment services.

Gender: All

Ages: 18 Years - Any

Updated: 2026-07-30

1 state

Addiction
Theraphy
RECRUITING

NCT07734363

Role of Craving in the Transition Across Level of Addiction Severity: A Longitudinal Study.

Substance/Alcohol Use disorders are defined as a loss of control over the use despite harmul consequences, as well as an intense and persistent urge to use, also called craving. Previous research has shown that craving is central among the diagnostic criteria for addiction, suggesting that it may be important in the onset and persistence of addiction. Addiction develops progressively, and it appears crucial to identify predictive markers of the transition from one level of severity to another over time. One hypothesis is that more closely linked symptoms (meaning symptoms that influence each other more) could be associated with greater severity and/or with the evolution of addiction severity over time. The aim of this project is to explore how the characteristics of the association between addiction symptoms (diagnostic criteria and symptoms as they occur in daily life), and the importance of craving relative to other symptoms, could serve as markers of different addiction severities and of the transition across these levels of severity.

Gender: All

Ages: 18 Years - Any

Updated: 2026-07-29

Addiction
TERMINATED

NCT06624137

Computer Game, Qualitative, and MEG/EEG Assessment of Serotonergic Psychedelics

This is an observational study which does NOT directly administer a psychedelic substance but rather recruits participants who are already participating in another clinical trial in which they may receive a serotonergic psychedelic. The goal of this observational study is to learn how the brain's information processing changes during and following administration of serotonergic psychedelics (psilocybin, N,N-Dimethyltryptamine/DMT, Lystergic Acid Diethylamide/LSD, etc.) for people with and without mental illness receiving serotonergic psychedelics through any clinical trial at Yale University. The main questions it aims to answer are: 1. Do serotonergic psychedelics cause the brain to rely on new information more than previously learned information while under the influence? What about 1 day, 5-14 days, and 4-6 weeks after use? 2. Do serotonergic psychedelics cause long-lasting side-effects in how people perceive (see, hear, feel, etc.) the world and how easily people change their beliefs? 3. How does the brain's electrical activity change after using serotonergic psychedelics? How does the balance between excitation and inhibition change while under their effect? 4. Can changes in how the brain uses information predict who will benefit from a psychedelic and who will have side effects from psychedelics? Researchers will compare with people given placebos to see what changes in brain processing are unique to serotonergic psychedelics. Participants will have the opportunity to do some combination of the following: 1. Online computer assessments consisting of games and questionnaires that probe how participants think. 2. Magnetoencephalography (MEG) or electroencephalography (EEG) with eyes closed and with repeated clicks, images, or sensations delivered. 3. A magnetic resonance imaging (MRI) scan. 4. Semi-structured qualitative interviews about their experience after taking a serotonergic psychedelic recorded via Zoom.

Gender: All

Ages: 18 Years - 65 Years

Updated: 2026-07-09

1 state

OCD
Major Depressive Disorder (MDD)
Alcohol Use Disorder (AUD)
+8
RECRUITING

NCT02108054

Behavioral and Functional Task Development, Implementation, and Testing

Background: \- Scientists know that alcohol use disorders affect brain structure. They want to know more about the effects of alcohol use disorders on a person s behavior. They want to develop tasks that can be done inside a scanner that can help them better understand these effects in later studies. Objective: \- To develop tasks that investigate a person s behavior that can be used in later studies. Eligibility: * Inpatient participants of another study. They must be physically healthy right-handed adults 18-60 years old. * Healthy right-handed volunteers 18-65 years old. Design: * Participants will be screened with medical history and physical exam. They will have an EKG to record heart activity. They will give blood and urine samples and have a psychiatric interview. * Participants will have between one and three visits. * Participants will be asked about their alcohol drinking to see if they have an alcohol use disorder. * Participants will complete one of three simple computerized tasks either inside the magnetic resonance imagining (MRI) scanner or outside of it. * The MRI scanner takes pictures of the brain. The scanner is a metal cylinder. Participants lie on a table that can slide in and out of the cylinder. They will be in the scanner for about 60 minutes. They may have to lie still for up to 20 minutes. The scanner makes loud knocking noises, but they will get earplugs.

Gender: All

Ages: 18 Years - 65 Years

Updated: 2026-06-30

1 state

Alcohol Dependence
Alcohol Drinking
Alcoholism
+2
RECRUITING

NCT07585006

Comparative Evaluation of Nicotine Analogs

This phase I trial compares electronic cigarette (EC) user preferences and smoking behaviors of nicotine analogs to nicotine to improve the understanding of nicotine analog addictiveness. Over the last ten years, EC use has become a major concern due to its increased use among adolescents and young adults. Though progress has been made in regulating nicotine containing products, some companies have shifted toward producing products containing nicotine analogs. ECs are battery-powered electronic devices designed to atomize a nicotine (the poisonous chemical found in tobacco)-containing liquid solution for inhalation in a manner that simulates smoking a tobacco cigarette. When nicotine enters the body, it causes an increased heart rate and use of oxygen by the heart, and a sense of well-being and relaxation. Nicotine analogs are compounds that are similar to nicotine in their chemical structure. Some nicotine analogs have been shown to have nicotine-like effects; however, more research is needed to prove they function similarly to nicotine and/or have similar effects. Comparing EC user preferences and smoking behaviors of nicotine analogs to nicotine may help improve the understanding of nicotine analog addictiveness. Additionally, combustible cigarette smoking is well-known to have deleterious effects on cardiovascular health. High blood pressure is one of the major health consequences of cigarette smoking and can increase the risk of hypertension, heart attack, and stroke. Although ECs have been marketed as a less harmful alternative to cigarette smoking, clinical trials have shown that vaping ECs can also lead to acute increases in blood pressure and heart rate. Nicotine can alter vascular reactivity by promoting the release of vasoconstrictors and suppressing the production of vasodilators. No research has examined how the synthetic nicotine in ECs affects hemodynamics, vascular health, and endothelial function. Assessing acute cardiovascular responses to nicotine analogs is therefore critical to enhancing our understanding of the potential cardiovascular risks associated with vaping ECs containing synthetic nicotine.

Gender: All

Ages: 21 Years - Any

Updated: 2026-06-26

1 state

Tobacco-Related Carcinoma
Addiction
RECRUITING

NCT07663474

Mobile Restriction on Dopamine Transporter

Restriction of mobile phone use for 2wks and undergo PET scanning for DAT bindinng. Free use of mobile phone use for 2wks and undergo PET scanning for DAT bindinng.

Gender: All

Ages: 19 Years - 40 Years

Updated: 2026-06-25

1 state

Addiction
SMARTPHONE OWNER
RECRUITING

NCT07340554

Neuroimaging of Adolescent Cannabis Use Treatment

This study is testing whether brain activity related to learning can help predict how well teens respond to a treatment program designed to reduce cannabis use. Teens ages 14-17 will complete a brain scan and then take part in 10 weekly virtual sessions where they report cannabis use and complete drug tests at home. Participants can earn prizes for staying cannabis-free.

Gender: All

Ages: 14 Years - 17 Years

Updated: 2026-06-22

1 state

Cannabis Use
Cannabis Dependence
Cannabis Use Disorder
+23
RECRUITING

NCT06618755

Motivational Interviews Post Hospitalisation on Maintaining AbstiNence for 1 Year après le Sevrage en Alcool

The aim of this clinical study is to evaluate the efficacy of reinforced inpatient aftercare versus usual care on the percentage of days of abstinence during the first year following withdrawal in adults with alcohol use disorders undergoing inpatient withdrawal. The hypothesis is that reinforced post-withdrawal follow-up, of the motivational interview type, during the first 4 months following hospitalisation, in addition to the usual care, would allow : * Increase the percentage of days of abstinence in the year following withdrawal. * Reduce the rate of relapse in the year following withdrawal. * An increase in the cumulative and maximum duration of abstinence, an increase in motivation to maintain the change initiated and a reduction in the use of other substances in the year following withdrawal. * A reduction in the impact of risk factors involved in the relapse process in the year following withdrawal. All participants will have assessments to monitor their abstinence and consumption. In addition to their assessments, the experimental group will have motivational talks once every 15 days.

Gender: All

Ages: 18 Years - Any

Updated: 2026-06-18

Alcohol Use Disorder
Addiction
Alcohol Withdrawal
+2
NOT YET RECRUITING

NCT07596251

Support Towards Addiction Recovery for Individuals With Criminal Legal System Involvement: The STAR Project

The goal of this clinical trial is to determine whether a new, paired coaching intervention improves outcomes for individuals with criminal legal system involvement recovering from substance use disorder, as well as the loved ones of those individuals. The initial phase (Year 1) includes a small preliminary pilot examining the feasibility of the intervention. During the full clinical trial (Years 2-5), this study aims to answer whether this approach... * ...improves the recovering person's recovery capital? * ...improves well-being, as well as resource knowledge and awareness, for the loved one? * ...improves social support and connection among both individuals? Participants will: * Meet regularly one-on-one with their individual coaches (a Recovery Coach for the recovering person; a Loved One Coach for the loved one) during the 6 week intervention period * Meet regularly as a group of four (both coaches and both participants) during this same period * Complete follow-up interviews with research staff at 6- and 12-weeks after beginning the study

Gender: All

Ages: 18 Years - 99 Years

Updated: 2026-05-28

Addiction
RECRUITING

NCT07595614

NLP Analysis of Weekly Narratives for Dynamic Clinical Assessment in SUD

This prospective observational study follows adults undergoing residential rehabilitation for severe substance use disorders at a specialized treatment center in Mexico. Participants provide weekly written narratives describing their emotions, challenges, coping strategies, and treatment experiences, and complete validated psychological questionnaires every two weeks, including the Generalized Anxiety Disorder-7 (GAD-7), Environmental Reward Observation Scale (EROS), Automatic Thoughts Questionnaire-8 (ATQ-8), and Behavioral Activation for Depression Scale (BADS). The study applies natural language processing (NLP) and machine learning methods to analyze participants' narratives and identify emotional, cognitive, and behavioral patterns associated with clinical change over time. Narrative-derived features are combined with questionnaire scores to generate a dynamic clinical risk representation that may help detect early signs of psychological worsening or improvement during residential treatment. Participants continue receiving standard residential care, and the study does not modify treatment decisions or clinical interventions. Up to 35 participants with sufficient longitudinal follow-up data will be included in the primary analysis. Data collection is expected to continue through September 2026.

Gender: MALE

Ages: 18 Years - Any

Updated: 2026-05-19

1 state

Substance Use Disorder (SUD)
Addiction
Anxiety
+2
COMPLETED

NCT07590154

Cross-sectional Functional Stratification Based on Psychometric Profiling and Machine Learning in Patients With Substance Use Disorders (SUD)

Substance use disorders (SUDs) show considerable clinical heterogeneity that limits the usefulness of traditional categorical diagnoses. This observational, cross-sectional study aims to apply an unsupervised deep learning method - an autoencoder - to learn continuous latent representations from standardised psychometric data and to explore whether those representations can help stratify clinical subpopulations. The investigators will recruit 155 adults undergoing residential treatment for SUD. Participants will complete six validated instruments assessing impulsivity (BIS-11), anger regulation (STAXI-2), behavioural activation/avoidance (BADS), borderline symptomatology (BSL-23), generalised anxiety (GAD-7), and environmental reward (EROS). Demographic and clinical variables (age, sex, primary substance, years of use, prior treatments) will also be recorded. After data cleaning and standardisation (z-scores), a symmetric autoencoder with a 12-dimensional bottleneck (architecture 21-32-24-12-24-32-21) will be trained using mean squared error loss. Regularisation includes L2 weight decay and dropout. The model will be trained 30 times with different random seeds to assess stability; the five best models (by validation pseudo-R²) will be combined into a weighted ensemble. Five-fold cross-validation will evaluate generalisation. For comparison, principal component analysis (PCA) will be applied to the same data. Gaussian mixture models (GMM) will be fitted on the latent space to explore potential clinical subgroups. The primary outcome is the stability of the latent representation (coefficient of variation of validation MSE across runs). Secondary outcomes include reconstruction performance (pseudo-R²) of the ensemble, comparison with PCA, and the interpretability of latent dimensions via correlations with original variables. GMM results will be described using BIC, silhouette width, bootstrap stability, and clinical characterisation of clusters. This study does not involve any intervention. Results will be hypothesis-generating and require external validation. No automated clinical decisions will be made.

Gender: All

Ages: 18 Years - 60 Years

Updated: 2026-05-18

1 state

Substance Abuse Disorder
Addiction
Clinical Stratification
+2
RECRUITING

NCT06973512

HABITS Study (Helping Addiction by Individualized Therapeutic Stimulation): Pilot Trial of Deep Brain Stimulation Guided By Stereoelectroencephalography for Treatment-Refractory Substance Use Disorders

Substance use disorder (SUD) or addiction to drugs/alcohol is a devastating disease. Over 40,000 overdose deaths have happened in Canada since 2016, 1 in 5 Canadians will have a SUD, and 70% of those with SUD continue to relapse, showing that we urgently need new treatments. The Helping Addiction by Individualized Therapeutic Stimulation (HABITS) Study is exploring deep brain stimulation (DBS) for people who have failed to quit harmful substances. Over 250,000 people have received DBS, which is well-established for Parkinson's disease and has evidence of success in major depression and obsessive-compulsive disorder. DBS uses electricity to directly stimulate areas of the brain. However, for DBS to work effectively, it needs to be personalized to each individual, which will be pursued through stereoelectroencephalography (SEEG). DBS and SEEG are minimally invasive and reversible, with a low risk of side effects. SEEG started over 70 years ago to find seizure location in the brain of children and adults with epilepsy. It now has been used for major depression and chronic pain to guide DBS. It involves inserting electrodes temporarily across critical brain areas and monitoring patients for several days. SEEG can provide an understanding of where addiction and craving are in the brain to guide the placement of DBS electrodes and device settings that are optimal for a person. In the HABITS Study, 10 participants will receive DBS guided by SEEG and undergo 11 study visits. Individuals will first undergo detoxification with CAMH. Then, they will receive DBS and SEEG at Toronto Western Hospital, where they will stay for 1 to 2 weeks. Finally, they will be followed for a year, where they will receive standard psychiatric care. SUD causes heavy burdens on individuals, families, healthcare systems, and society. The HABITS Study promises to personalize DBS to treat those who are struggling with severe addiction.

Gender: All

Ages: 25 Years - 65 Years

Updated: 2026-04-29

1 state

Addiction
Substance Use Disorder (SUD)
COMPLETED

NCT07071883

Group Activities to Support Addiction Recovery

The purpose of this study is to pilot the use of Holotropic Breathwork (HB) for individuals seeking to recover from addiction. The study will have two arms: A--for individuals in residential treatment programs, B--for individuals living in the community. Arm A will use a cluster randomized intervention, providing HB for individuals at two facilities and a Multiple Modality (MM) intervention (soundbath, meditation, and a film/discussion) at a third facility. In Arm B, we seek to measure the feasibility, acceptability, and preliminary impact of HB among people with addiction living in the community. Arm B will be comprised of a single group and participants in this group will receive the same HB experience as the participants in the Arm A HB group. HB is the practice of self-directed hyperventilation while lying down with the support of a selected music set and trained facilitators. Participants may experience an expanded state of consciousness with altered cognition, perception, and emotions. HB has been associated improved mental functioning among the general public and people in addiction treatment, but has never been evaluated in a controlled trial. Inclusion criteria consist of being 19 years of age or older and having met criteria for a substance use disorder within the past five years. Additional inclusion criteria for participants in arm A include being in a residential addiction treatment program at CenterPointe or the Bridge. Exclusion criteria form the Arm A HB group and the Arm B group include having been diagnosed with a bipolar disorder or a psychotic disorder or having had psychotic symptoms at any point in life, diagnosed with a cardiac condition, received care for a cardiac condition, or have current cardiac symptoms, ever diagnosed with a seizure disorder, current uncontrolled hypertension (140/90 or greater), diagnosed with glaucoma or retinal detachment, recent surgeries, or currently pregnant. Four breathwork sessions will be held: two at the UNMC College of Nursing in Lincoln, one at CenterPointe in Omaha, and one at The Bridge in Lincoln. One MM session will be held at The Bridge in Lincoln.

Gender: All

Ages: 19 Years - Any

Updated: 2026-04-14

1 state

Addiction
Substance Use Disorders (SUD)
COMPLETED

NCT02966873

Clinical Trial for Alcohol Use Disorder and Post Traumatic Stress Disorder (PTSD)

This is a randomized controlled Phase II clinical trial designed to evaluate the effects of N-acetylcysteine (NAC) in reducing Alcohol Use Disorder (AUD) severity and Post Traumatic Stress Disorder (PTSD) symptomatology among individuals with current AUD and PTSD.

Gender: All

Ages: 18 Years - 70 Years

Updated: 2026-04-13

1 state

Post Traumatic Stress Disorder (PTSD)
Addiction
Alcohol Abuse
NOT YET RECRUITING

NCT07520617

Evaluation of the ADD'Pro Vocational Reintegration Program (ADD-PRO-EVAL)

The goal of this clinical trial is to evaluate whether an integrated medico-psychosocial vocational support program (ADD'Pro) can improve employment outcomes in adults with substance use disorders receiving care at a specialized addiction day hospital. The main question it aims to answer is: \- Does participation in the ADD'Pro program increase the rate of competitive employment (at least one day worked in the open labour market) at 6 months compared to standard employment services? Researchers will compare participants enrolled in the ADD'Pro program to participants referred to conventional employment services (France Travail or Cap Emploi) to see if structured, dual medico-psychosocial support leads to higher rates of vocational reintegration, better employment preparation, improved quality of life, and reduced physiological stress reactivity. Participants will: * Be randomly assigned to either the ADD'Pro program or standard employment services * If assigned to ADD'Pro: receive immediate individualised support from a vocational counsellor (CIP) at the CeCler Association, running in parallel with their hospital addiction care, with no fixed end date * If assigned to standard care: be referred to conventional employment services with monthly follow-up interviews at the hospital, and the option to join ADD'Pro after 6 months * Complete structured interviews and validated questionnaires at inclusion, 3, 6, and 12 months * A sub-sample of up to 50 participants will additionally take part in a simulated job interview stress test (adapted TSST) with salivary biomarker collection and heart rate monitoring at inclusion and 6 months

Gender: All

Ages: 16 Years - 70 Years

Updated: 2026-04-09

Addiction
Addiction Disorders
Substance Use Recovery
+9
NOT YET RECRUITING

NCT07495839

The Impact of Equine-Assisted Therapy on Mental Health and Addictive Behaviors in Patients Receiving Addiction Treatment

Addiction is a major public health issue. According to the World Health Organization (2024), approximately 400 million people worldwide suffer from alcohol- or drug-related disorders, resulting in nearly 3.2 million deaths per year. In France, the situation is also cause for concern: approximately three million people engage in risky alcohol consumption, thirteen million smoke daily, and nearly one and a half million use illicit drugs, primarily cannabis. Addiction, defined by the National Institute on Drug Abuse (NIDA) as a chronic, relapsing brain disorder, is characterized by the compulsive pursuit and use of a substance despite knowledge of its harmful effects. Its development depends on multiple factors: personal (trauma, psychiatric disorders, genetic predispositions), environmental (stress, isolation, family context), and those related to the substance itself (addictive potential). The diagnosis of substance use disorders is based on 11 criteria defined in the \*Diagnostic and Statistical Manual of Mental Disorders\* (DSM-5), the main ones being: loss of self-control, interference of substance use with academic or occupational activities, continued use despite awareness of the problems it causes, and a new central criterion, craving, defined as an irresistible urge to use, which serves as both a symptom and a diagnostic and prognostic marker because it is a predictor of relapse. The cumulative total of criteria allows the disorder to be classified as mild (2-3), moderate (4-5), or severe (≤ 6). Since the 2020 health crisis, researchers have observed an increase in the use of psychoactive substances, particularly among vulnerable populations. Despite public policy efforts and treatment programs, relapses remain common after treatment, affecting 60 to 70% of patients within six months of their hospitalization. This phenomenon is also observed at La Musse Hospital, where many patients admitted to the nutrition and alcoholism unit express a sense of emptiness upon returning home: a void in relationships, therapy, and daily activities. This feeling often contributes to a return to substance use. To address these relapses, this study aims to evaluate the impact of a post-hospitalization equine-assisted therapy program on the mental health and addictive behaviors of patients receiving addiction treatment. Already used at La Musse Hospital as part of the care pathway, equine-assisted therapy is based on the interaction between the patient and the horse in a therapeutic setting. Several studies have demonstrated the benefits of this approach on emotional regulation, self-confidence, stress management, and overall well-being. This prospective, single-center, interventional study will include twenty-two patients who have been hospitalized at least once in the nutrition and alcoholism unit at La Musse Hospital or another facility. Participants will be randomly assigned to either a group receiving post-hospitalization equine-assisted therapy or a control group.

Gender: All

Ages: 18 Years - Any

Updated: 2026-04-01

Equine-assisted Therapy
Addiction
Recidivism
+2
RECRUITING

NCT06885606

The Use of tDCS for Vaping Reduction

Project Summary - tDCS for Vaping Reduction Background: While the prevalence of tobacco smoking has plateaued over the last several years, the prevalence of nicotine vaping (e-cigarettes) continues to increase exponentially in Canada. Originally touted as a safe alternative to smoking, e-cigarette use or vaping is now most popular among youth and young adults. The high prevalence of e-cigarette use, coupled with growing evidence of associated harms and reports of addiction and difficulties in quitting reinforces the urgent need to develop and test methods to attenuate e-cigarette craving as a step towards developing approaches to vaping cessation that are brief, inexpensive and effective. Non-invasive brain stimulation techniques have become a popular area of research as a treatment option for substance use disorders with growing evidence of their effectiveness for a variety of addictions. One of these techniques, transcranial direct current stimulation (tDCS), has been shown to decrease cigarette craving and consumption. Thus, the purpose of this pilot study is to evaluate the effectiveness of using tDCS for vaping reduction in e-cigarette users. Methods: This will be a double-blind sham-controlled randomized trial whereby 40 daily nicotine-containing e-cigarette users will be recruited to undergo 10 consecutive daily sessions of tDCS (Monday to Friday for 2 weeks). Participants will be randomized (1:1) to either sham (0mA) or active tDCS (2mA), with the anode at the left dorsolateral prefrontal cortex (DLPFC) and cathode at the right DLPFC. The primary outcome is vaping frequency (puffs/day and nicotine pods/week) at end of treatment (2 weeks). The secondary outcome will be e-cigarette craving. Participants will be followed-up via the phone at 1 month and 3 months post randomization respectively. Implication: This will be the first treatment study to target vaping reduction. There are currently no established treatment options for e-cigarette addiction and medications traditionally used for smoking cessation only address withdrawal symptoms and not addiction pathology. Thus, findings from this study may be used to inform future designs of vaping reduction strategies or vaping cessation.

Gender: All

Ages: 18 Years - 65 Years

Updated: 2026-03-19

1 state

Vaping
Addiction
Transcranial Direct Current Stimulation(tDCS)
ACTIVE NOT RECRUITING

NCT02836080

Integrated Collaborative Care Teams for Youth With Mental Health and/or Addiction Challenges (YouthCan IMPACT)

Among youth, the prevalence of mental health and addiction (MHA) disorders is roughly 20%, yet youth are challenged to access services in a timely fashion. To address MHA system gaps, this study will test the benefits of an Integrated Collaborative Care Team (ICCT) model for at-risk youth with MHA challenges. In partnership with community agencies, adolescent psychiatry hospital departments, and family health teams, investigators have developed an innovative model of service provision involving rapid access to MHA services. This model will be implemented and compared to the usual treatment youth receive in hospital-based, outpatient, mental health clinics in Toronto. A rapid, systematic, approach to MHA services geared to need in a youth-friendly environment is expected to result in better MHA outcomes for youth. Moreover, the ICCT approach is expected to decrease service wait-times, be more youth- and family-centred, and be more cost-effective.

Gender: All

Ages: 14 Years - 18 Years

Updated: 2026-03-17

1 state

Mental Disorders
Addiction