Clinical Research Directory

SV2 PET Imaging With [11C]APP311

The aim of this study is to evaluate a new SV2A tracer, \[11C\]APP311, in healthy aging and neuropsychiatric disorders including psychotic disorders and cannabis use disorders.

Tirzepatide for the Treatment of Cannabis Use Disorder

This is a pilot randomized cross-over trial to examine the effects of tirzepatide on cue-reactivity among individuals with cannabis use disorder.

Sex Differences in Neurobehavioral Response to THC

This study investigates sex differences in reward processing following acute THC administration in adults with cannabis use disorder (CUD). Using multimodal neuroimaging (MRS and fMRI), the study will assess glutamate levels in the nucleus accumbens and striatal BOLD response to monetary reward anticipation. Participants will complete two counterbalanced dosing sessions (oral THC 40 mg vs. placebo).

Endocannabinoids in Reward

This study will examine sex differences in the effects of cannabis in people that regularly use it. Men and women that use cannabis at least 4 days a week will participate in a study involving 3 in-person visits. The first visit will be used to determine eligibility for the study. The other two visits will last 7 hours each and take place at least two days apart. Visits include administration of either THC, the chemical responsible for many of the psychoactive effects of cannabis, or a placebo; completion of questionnaires; and a 1-hour brain scan. One visit will also include a blood draw for genetic testing.

Delayed-Release, Extended-Release Methylphenidate (Jornay PM) for Adolescents and Young Adults With Attention-Deficit/Hyperactivity Disorder and Cannabis Use Disorder

The goal of this clinical trial is to look at how delayed-release, extended-release methylphenidate (Jornay PM), an FDA-approved medication for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD), works to treat ADHD symptoms in adolescents and young adults (ages 16-26) with ADHD and Cannabis Use Disorder. Researchers will compare delayed-release, extended-release methylphenidate to a placebo (a look-alike substance that contains no drug). Participants will be assigned to take either delayed-release, extended-release methylphenidate or a placebo every night over 12 weeks. Throughout the study, participants will provide urine samples and complete questionnaires about their ADHD symptoms, cannabis use, and other substance use.

Lemborexant for Cannabis Use Disorder

The goal of this clinical trial is to investigate the use of Lemborexant as a treatment for moderate to severe Cannabis Use Disorder (CUD). The main questions it aims to answer are: 1. Is Lemborexant safe, feasible, and tolerable to use in the CUD population? 2. Will the use of Lemborexant for CUD help to decrease cannabis use, improve sleep, decrease cannabis withdrawal symptoms, and improve cognition? Researchers will compare 10mg Lemborexant to placebo. Participants will: * Take 10mg Lemborexant (or placebo) nightly for 21 nights (treatment phase). * Wear an actigraphy watch continuously for the treatment phase. * Complete a pre-screen survey, attend an in-person screening session, 4 in-person lab visits (weekly from days 0-21), and a virtual follow-up visit 2 weeks after the treatment phase. * Complete a short daily survey for 35 days total.

Trial of Tirzepatide for the Treatment of Cannabis Use Disorder

The purpose of this randomized, double-blind, placebo-controlled, multi-site clinical trial is to evaluate the safety and efficacy of tirzepatide in a sample of 100 patients diagnosed with moderate or severe CUD by DSM-5 criteria.

Study of an Oral Fluid Testing Approach

The purpose of this study is to identify and evaluate oral fluid testing as a biologic measure of cannabis use days that can be assessed remotely. The researchers will conduct this fully virtual study among a community sample of 200 individuals aged 18-30 years who have used cannabis at least 1 time per week on average in the past 30 days. Participants will complete oral fluid (saliva) tests, urine tests, and Timeline Follow-back interviews (self-report) that indicate their recent cannabis use (delta-9-THC). Participants will present for 3 virtual study visits across \~ 3-4 weeks and be asked to complete activities in between: Study Visit 1 (Day 0; informed consent, baseline survey, TLFB interview), Study Visit 2 (\~ Day 7; TLFB interview, urine testing), 6 days of at-home videorecorded oral fluid testing, Study Visit 3 (\~ Day 21; TLFB interview, urine test, oral fluid test, survey, interview). Individuals age 18-30 are invited to screen here: https://redcap.link/softa-bch

Investigating the Neural Correlates of Cognitive Function in Psychosis Patients and Non-Psychiatric Controls With Cannabis Use

Cognitive impairment is well established in people with psychosis and is associated with cannabis use. The current study will investigate the neurobiological basis of cognitive change associated with 28-days of cannabis abstinence in people with psychosis and non-psychiatric controls with cannabis use. Participants will be randomized to a cannabis abstinent group or a non-abstinent control group and will undergo magnetic resonance imaging at baseline and following 28-days of abstinence. This study will help characterize the neuropathophysiological processes underlying cognitive dysfunction associated with cannabis use and its recovery which may guide the development of novel interventions for problematic cannabis use.

Genetic Basis of the Risk and Consequences of Cannabis Exposure in Humans

Cannabis is widely used worldwide and is associated with negative outcomes including cannabis use disorder (CanUD), psychosis, and cognitive impairment amongst others. Given the legalization of "recreational" and "medical" cannabis globally, the increasing availability of cannabis, the higher potency of cannabis, the availability of highly potent cannabinoid products, the commercialization of cannabis, and the rising rates of cannabis use, it is critical to understand how genetic factors influence 1) an individual's vulnerability for addiction and psychosis, 2) the response to cannabinoids, 3) the response to novel treatments for CanUD. CanUD is strongly genetically influenced; the investigators published the first CanUD genomewide association study (GWAS) with genomewide-significant results; however, the precise nature of the contribution of genetic factors in the development of CanUD is still not clear. Cannabis exposure has also been linked to a number of psychosis outcomes including schizophrenia (SCZ). SCZ is highly heritable and population-based and genetics studies both support a bidirectional genetic relationship between SCZ and CanUD. However, the precise contribution of genetic factors in the development of psychosis outcomes related to cannabis are not clear.

Regulated Cannabis Access in Basel

The randomised controlled study on regulated cannabis access in pharmacies in Basel aims to investigate the effects of regulated cannabis access on consumption behaviour and mental and physical health in comparison to the illegal market.

Evaluation of a Brief Computerized and Smart Phone-based Intervention for Stress in Regular Cannabis Users

The prevalence of daily cannabis use and Cannabis Use Disorder (CUD) has increased in the United States over the past two decades. Brief, computerized harm reduction interventions that target specific high-risk CUD populations could be an efficient approach to reducing CUD. Distress intolerance , which refers to the tendency to negatively appraise and escape aversive emotional states, is a risk factor associated with stress-related cannabis use motivation and CUD severity/chronicity. Thus, a brief, accessible, low-cost intervention that reduces distress intolerance in those with CUD and elevated distress intolerance could have a significant public health impact. This proposed project aims to optimize an existing two-session computerized distress tolerance intervention and test its impact on distress intolerance and cannabis use outcomes in a randomized controlled trial. Specifically, the intervention will be condensed to one-session, its active ingredient bolstered, and augmented with smart phone-delivered therapy reminders. After obtaining feedback on the modified Emotional Engagement Distress Tolerance Intervention in a small sample, the intervention's efficacy compared to a stringent, credible, time-matched health education control intervention will be tested in a randomized controlled trial in 80 cannabis users with CUD and high distress intolerance. Distress intolerance, cannabis use, and psychosocial functioning outcomes will be evaluated. As an exploratory aim, a wristworn device will be used to measure objective stress responding in the real-world during the intervention period. Our central hypothesis is that, compared to a control intervention, the Emotional Engagement Distress Tolerance Intervention will produce superior reductions distress intolerance, stress-related cannabis use motivation, disordered cannabis use, and psychosocial functioning.

Applying Neuromodulation to Boost the Efficacy of Motivational Interviewing

The goal of this clinical trial is to learn how adding brain stimulation to a brief counseling session affects adults with cannabis use disorder. The counseling session uses motivational interviewing, which helps people talk through their reasons for changing or not changing cannabis use. The brain stimulation is called transcranial alternating current stimulation (tACS). tACS uses electrodes on the scalp to give a very weak electrical current for a short time. The main questions it aims to answer are: * Does active tACS affect what participants say during the counseling session? * Does active tACS change brain activity after the session? * Is active tACS related to less cannabis use during the month after the session? Researchers will compare motivational interviewing with active tACS to motivational interviewing with placebo stimulation. Placebo stimulation uses the same setup but does not provide the active 30-minute stimulation. Participants will be assigned by chance to one of these groups, and neither participants nor the study staff member running the session will know which type of stimulation is used. Participants will complete questionnaires, breath and urine tests, a recorded counseling session during active or placebo stimulation, MEG and MRI brain scans, daily text-message check-ins about cannabis use, and follow-up questionnaires about one month later.

Cannabinoids and Biological Reactivity to Stress

The goal of this study is to test the impact of two drugs that produce temporary stress-like symptoms, both in isolation and together, on cannabis use motivation in individuals with Cannabis Use Disorder. The main questions it will answer are: 1. How do different forms of stress affect cannabis use motivation? 2. How do different forms of stress affect the body's natural cannabinoids? Researchers will compare a placebo to both drugs in isolation, as well as together, across four separate lab visits. Participants will: 1\) Complete a clinical screening interview (by phone or in-person) and visit the lab for a medical screening, and if eligible: a) Visit the lab four times where they will: i). Take one of four drug combinations ii). Complete an interview, questionnaires, and computerized tasks iii). Have their brain activity recorded with an EEG cap iv). Provide three blood samples

Developing a Telehealth + mHealth Cannabis Use Intervention for Young Adults

The goal of this clinical trial is to determine 1) feasibility of the MOMENT-V intervention for cannabis use disorder in young adults, 2) feasibility of conducting the trial remotely, and 3) whether the MOMENT-V intervention reduces cannabis use frequency and problems. Researchers will compare the MOMENT-V intervention to usual care enhanced by a counselor meeting. Participants will either meet with a counselor two times and use an app on their phone for two weeks, or meet with a counselor briefly one time. All participants will be asked to complete electronic surveys, interviews with a research assistant, and saliva drug testing at home over three months.

Pregnenolone for Cannabis Use Disorder and Depression

This is UG3 phase of a multi-site, milestone-driven UG3/UH3 research program evaluating pregnenolone for individuals with co-occurring cannabis use disorder (CUD) and major depressive disorder (MDD). Pregnenolone is a neurosteroid that modulates cannabinoid receptor signaling and may reduce cannabis-related effects while also improving mood-related symptoms. The primary objective of the UG3 phase is to establish feasibility and generate preliminary data to support a subsequent UH3 randomized clinical trial. Key preparatory activities include obtaining regulatory approvals (including FDA Investigational New Drug \[IND\] protocol amendment and Institutional Review Board approvals), harmonizing study procedures across participating sites, and implementing data management and monitoring systems. The UG3 phase includes two main components. First, a pharmacokinetic study willcharacterize pregnenolone pharmacokinetics in adults with CUD and MDD, including measures such as half-life and clearance. Second, a pilot clinical study will evaluate the feasibility, safety, and tolerability of pregnenolone administered orally over approximately 12 weeks. Feasibility outcomes include recruitment rates, retention, and adherence to study procedures, while safety and tolerability will be assessed through adverse event monitoring and discontinuation rates. Participants will be adults aged 18 to 50 years with diagnoses of cannabis use disorder and major depressive disorder, who report frequent cannabis use and express interest in reducing their use. Clinical assessments of cannabis use, mood symptoms, and related behavioral outcomes will be collected. The UG3 phase will be used to refine study procedures, inform dosing strategies, and establish benchmarks necessary for progression to the UH3 phase. The subsequent UH3 phase will involve a multi-site, randomized, double-blind, placebo-controlled trial evaluating the efficacy of pregnenolone in reducing cannabis use and improving depressive symptoms in this population.

Use of a Generative AI (Gen-AI) Chatbot for Anxiety and Depression Among Persons With Cannabis Use

The goal of this clinical trial is to learn if Therabot-CALM (Cannabis, Anxiety, Low Mood) has acceptability among users and could work to improve the symptoms of persons with cannabis use disorder and anxiety and/or depression. The main question it aims to answer is: What is the usability, feasibility, and acceptability of Therabot-CALM in persons with Cannabis Use Disorder and Anxiety and/or Depression? Participants will * Take a screening questionnaire * Participate in two virtual 1-hour interviews to provide feedback on app design and suggest features. * Engage with Therabot-CALM in a 4-week clinical trial and provide feedback on their app experience in a third virtual interview

Evaluation of Suvorexant for Reduction of Brain Reactivity in Patients With Cannabis Use Disorder (Pilot Study)

The goal of this study is to observe the impact of suvorexant, sold as BELSOMRA, on brain activity of people who frequently use cannabis. Suvorexant is an FDA-approved medication to treat insomnia. Researchers think that suvorexant may reduce activity in certain parts of the brain associated with cannabis use. Researchers are studying if this medication does affect brain activity in these areas. For this study, participants will be asked to complete four study visits over approximately 14 days. Each study visit will include interviews, questionnaires, and collection of biological samples for laboratory testing. All participants will be asked to take suvorexant, an FDA approved medication for treatment of insomnia, for 14 days. They will complete two one-hour functional Magnetic Resonance Imaging (fMRI) scans: one before starting the study medication and one after 14 days of taking the study medication. MRI is used in typical medical settings and is considered to be safe. Participants will also be asked to complete a short daily survey for approximately 14 days.

The Neural Underpinnings of Depression and Cannabis Use in Young People Living With HIV

To elucidate mechanisms of substance use disorders (SUD) and comorbid mental illnesses in people living with HIV (PLWH), the study team seeks to investigate reward and pain circuitry in cannabis use and depression comorbidity, two highly prevalent conditions in PLWH. The study team proposes a tightly integrative study to test the overall hypothesis that cannabis use and depression in young PLWH have an additive effect, inducing both reward deficits and pain hypersensitivity, and that this pattern will predict worse outcomes at 1 year follow-up.

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.

Longitudinal Outpatient Treatment for Cannabis Use Disorder

This study is a placebo-controlled randomized trial comparing the effects of hemp-derived cannabidiol (CBD) with and without Delta-9-tetrahydrocannabinol (THC), relative to placebo, on reducing cannabis use and cannabis use disorder (CUD) symptoms in adult treatment seeking cannabis concentrate users with CUD. Participants enroll in the study for 8 weeks (with telehealth follow-ups at 12 and 16 weeks) and are randomized to either full spectrum CBD, broad spectrum CBD, or placebo. Participants are also engaged in five weeks of psychotherapy treatment for CUD. Blood is collected to quantify investigational drug exposure and cannabis use. Participants also complete self-report measures of medical history, sleep quality, subjective cognitive function, physical activity, psychological functioning, substance use, and acute drug effects.

Preliminary Efficacy Trial of a Digital Intervention for Depression and Cannabis Use

The purpose of this study is to examine the feasibility, acceptability, and preliminary efficacy of a digital intervention for co-occurring cannabis use and depression. Participants will be randomized to complete Amplification of Positivity - Cannabis Use (AMP-C) or symptom tracking. The main outcomes will include changes in depressive symptoms and cannabis use, as well as usability ratings.

Effect of Semaglutide on Cannabis Use in Adults With Cannabis Use Disorder

The HASHTAG Study is investigating whether the medicine semaglutide can help adults with cannabis use disorder (CUD) reduce their cannabis use. Participants will be randomly assigned to receive either semaglutide or a placebo. The first 50 participants will have functional brain scans (fMRI) to investigate how the brain responds to cannabis-related cues. The main outcome after 20 weeks is whether semaglutide reduces cannabis use compared to placebo. Changes in brain activity in response to cannabis cues will be explored as a secondary outcome.

A Study of Cannabidiol in Young Adult Cannabis Users

The investigators will study the harm-reducing effect of hemp-derived CBD in non-treatment-seeking emerging adults who use cannabis regularly. The study will use a novel naturalistic cannabis administration approach, which examines ecologically valid cannabis use utilizing a mobile lab setting to assess the effects of the cannabis products the participants regularly use. The investigators will recruit a sample of emerging adults, half of whom primarily use flower products and half of whom primarily use concentrate products. Individuals will be randomly assigned to hemp-derived CBD or placebo.