Clinical Research Directory

Clinician Practice Companion to Address Youth Substance Use

Substance use, including the use of opioids, cannabis, and other drugs, is common among adolescents and young adults, and overdose has become a leading cause of death among youth in Canada and the United States. Many young people who use substances also experience co-occurring mental health concerns. Evidence-based approaches to youth substance use care exist, including harm reduction, overdose prevention (such as naloxone and take-home drug testing strips), and medications for addiction treatment. These approaches remain adult-oriented, however, unevenly implemented in youth-serving settings, and insufficiently centered on the needs and goals of youth and their families. This study develops and pilot tests a written "practice companion" that helps clinicians and other trusted adults provide developmentally appropriate substance use care to youth ages 14 to 24 in hospital and community settings. The practice companion offers practical, easy-to-use guidance organized by substance and by pattern of use. It addresses cannabis and other substances that youth commonly use and that clinicians frequently seek support with, alongside a strong focus on overdose prevention through its core elements: naloxone, take-home drug testing strips, harm reduction education, and medications for opioid use disorder. It also attends to co-occurring mental health needs and to how gender, sexuality, housing instability, and other social and structural contexts shape substance use and care. The research team will first interview youth who use substances, their families and caregivers, and clinicians to learn how each element of care should be adapted for young people. The team will then produce the practice companion and pilot test it with 60 youth across three sites, in British Columbia, Québec, and Massachusetts. After receiving care guided by the practice companion, youth will complete an interview about whether the care was relevant, useful, appropriate, and acceptable. Families and clinicians will also be interviewed to assess how feasible, sustainable, and faithful to its design the practice companion is in practice. Throughout the study, the team will work closely with youth and families who have lived experience through a community-based participatory research approach that includes Community Advisory Boards. The work centers equity for Black, Indigenous, and other racialized youth, Two-Spirit and LGBTQ+ youth, and youth experiencing housing instability. Findings will guide a larger future study of the practice companion's effectiveness.

Project e-PBI+ - Parent Intervention to Reduce College Student Drinking and Cannabis Use

College students' risky drinking and cannabis use are major public health problems. The harms associated with risky drinking have been well-documented (such as deaths, blackouts, injuries, assaults, arrests, sexual consequences, academic consequences). Both college health administrators and parents have requested electronic parent-based interventions (e-PBIs) with additional content on cannabis. Parents have demonstrated ample motivation to communicate with their teens. The proposed research will attempt to enhance an existing effective e-PBI, curb the alarming trends noted in the literature, and move the field forward by conducting a randomized controlled trial testing a modified version of the e-PBI that includes updated content including the most up-to-date scientific information from cannabis studies (e-PBI+).

Effects of Cannabis Species Labeling and Marketing on Perceptual, Subjective and Objective Use Outcomes (Aim 2 Study)

This study looks at how cannabis product label and marketing claims affect product perceptions, use expectancies, and use intentions among inexperienced and experienced cannabis users. Participants will answer online survey questions on their perceptions of a cannabis product advertisement.

Gabapentin for Restoring GABA/Glutamate Homeostasis in Co-occurring Bipolar and Cannabis Use Disorders

This research study evaluates the effects of an FDA-approved medication Gabapentin in individuals with Bipolar Disorder who smoke marijuana. Participants in the study will will be assigned to take either Gabapentin or a matched placebo. Study medication will be taken for 17 days. There will be 5 study visits, with 2 MRI brain imaging scans completed. Questionnaires and clinical interview measures will be completed at study visits along with consistent assessment of potential side effects from study medication.

Testing Warning Labels for Retail Cannabis Products Using a Discrete Choice Experiment

This discrete choice experiment (DCE) study aims to address gaps in cannabis packaging regulatory research by testing how variations in cannabis packaging and health warning design impact reactions to packaging and intentions about cannabis use. The goal of this work is to identify the most effective combination of health warning features to improve consumer awareness of cannabis health risks. Establishing criteria for cannabis products in the US is critical because inconsistent state guidelines have resulted in contradictory policies in legal retail states, arguably leading to increased hazardous use and failure to meet public health standards. The contributions of this study's outcomes are expected to be significant because they will benefit public health as cannabis becomes available in legal retail markets and regulatory and governmental agencies seek effective ways to communicate cannabis risks to the public.

Developing and Testing an Online Intervention for Alcohol and Cannabis Misuse and Healthy Relationship Skills Among Young Adult Couples

The goal of this clinical trial is to develop and test a brief online intervention to reduce alcohol and cannabis misuse and improve healthy relationship skills among young adult couples. The main questions it aims to answer are: * Will the intervention be feasible and acceptable to young adult couples? * Will the intervention demonstrate initial efficacy in reducing risky substance use and increasing relationship functioning? Eligible couples will complete a virtual baseline session and be randomized to intervention condition (online intervention with 3-5 weeks of self-paced modules) or control condition (no intervention). Couples will complete two follow-up surveys (post-assessment - approximately 5 weeks after baseline, 3-month). Couples in the control condition will be offered the intervention after 3-month follow-up. Researchers will compare intervention and control groups to see if there there is a difference between the groups on substance misuse and relationship functioning at post-assessment and 3-month follow-up.

Feasibility and Acceptability Trial to Reduce Tobacco and Cannabis Use During Pregnancy and Postpartum

Using both tobacco and cannabis during pregnancy is more common in minoritized groups and can make quitting smoking in pregnancy and remaining smoke free postpartum difficult. Investigators will test an intervention to address prenatal depressive symptoms to encourage people to quit tobacco and cannabis during pregnancy and stay quit postpartum.

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).

Cannabis and Opioid Use Disorder, Study 2

This inpatient study enrolls healthy individuals who have opioid use disorder. Participants live at the University of Kentucky Hospital for approx. 6 weeks. During this time, we will examine how repeated doses of oral cannabis and acute doses of oral and inhaled cannabis 1) modify the intensity and time course of opioid withdrawal, 2) modify the effects of intranasal opioid administration and 3) impact the safety of opioid administration.

Cannabis Effects on Opioid Self-Administration

The study will enroll participants with opioid use disorder and participants will reside at the University of Kentucky Hospital for this 6-week inpatient trial. During this time, double-blind doses of cannabis and opioids will be administered. The goal of the project is to determine if cannabis can alter the drive/desire to take opioids.

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.

Smart Talk: Cannabis Awareness and Prevention Curriculum Evaluation

The Stanford REACH Lab's SMART TALK: Cannabis Awareness and Prevention Toolkit is a free, online educational resource to be used by educators to increase knowledge and awareness of cannabis and reduce use among youth. The aim of this study is to investigate the extent to which the curriculum changes middle and high school students' intentions to use and actual use of cannabis.

Feasibility/Acceptability of a Brief Motivational Intervention for Frequent/High-Intensity Cannabis Use

The study aims to develop a novel brief motivational mobile health (mHealth) intervention for frequent and/or high-intensity cannabis use for non-collegiate young adults. A total of 120 young adults (ages 18-29, not enrolled at or attending a 4-year college or university) will be randomized to receive a mHealth intervention with text messages for five weeks or to an online resource/program with psychoeducation information about cannabis. The mHealth intervention will focus on prompting the young adult to reflect on their journey with cannabis and to reflect on their personal goals and how cannabis is reflected in these goals. Additional mini-modules are included related to topics such as motivations for use, perceived norms and tracking cannabis use. Participants will return to the program each week to reflect on the prior week and reflect on goals for the upcoming week. All participants will complete a program satisfaction survey and complete follow-up assessments at 3- and 6-months post-program.

Precision Brain Stimulation to Reduce Cannabis Craving in Schizophrenia

The central hypothesis is this: Brain circuits most relevant to cannabis use in schizophrenia are distinct from pathways identified in healthy controls who use cannabis. This study seeks to provide evidence that targeted stimulation of the DMN leads to both altered network activity and a concomitant behavioral change in cue-induced craving and cognitive performance in individuals with schizophrenia and schizoaffective disorder, while targeted stimulation of the L DLPFC leads to these changes in healthy controls who use cannabis. This study will test a model that integrates brain network pathophysiology and cognition to 1) explain the prevalence of cannabis use in schizophrenia and 2) identify a target for engagement in schizophrenia. This study seeks to establish a neuroscientific framework to guide future treatment-oriented studies aimed at reducing craving and improving cognitive performance in individuals with schizophrenia and schizoaffective disorder. This is a study of the effect of 2 rTMS interventions on functional connectivity and craving in individuals with schizophrenia or schizoaffective disorder and healthy controls who use cannabis. Aim 1: Target Engagement: Determine if rTMS manipulates functional connectivity of each target (DMN, L DLPFC) (n=100). Aim 2: Clinical Efficacy: Determine if rTMS affects cue-induced craving and if craving change correlates with change in functional connectivity (n=100). As an exploratory analysis, the factors that explain individual variance in rTMS-induced connectivity change will also be explored.

Acute Effects of Cannabis on Cognition and Affect

This study will examine how a moderate dose of THC affects mood, stress responses, and cognitive functioning in regular cannabis users. The study uses a double-blind, placebo-controlled, crossover design, meaning each participant will complete two sessions. Specifically, each participant will be given active cannabis (20 mg THC) in one session, and placebo in the other session. The order will be randomized across participants, so half will receive cannabis first, and the other half will receive placebo first. Ninety adults who use cannabis at least weekly will be recruited from the local community. After an online screening survey, eligible participants will attend a laboratory visit where the participants will provide informed consent and complete saliva and urine drug tests to confirm recent abstinence from cannabis and absence of other drugs. Participants who pass screening will complete baseline questionnaires of cannabis use patterns, depression, anxiety, ADHD symptoms, emotion regulation, affect, and demographic information. Cannabis and placebo materials (obtained from NIDA) will be vaporized using a Volcano vaporizer device. Participants will inhale the vapor under supervision, and neither the participant nor the researcher assessing outcomes will know which product is administered. After vaping, participants will complete repeated mood ratings, saliva samples, and a battery of cognitive tests assessing executive functions like planning, inhibition, working memory, and cognitive flexibility. Participants will also complete a standardized stress challenge (the Maastricht Acute Stress Test), which involves repeated trials of placing their hand in cold water and doing challenging mental math, followed by additional mood ratings and saliva samples. The participants will then watch a nature video and report their feelings of awe and affect. At the end of each session, participants will remain in a supervised room with entertainment and snacks until at least four hours have passed since vaping and the participants report feeling sober. The participants will then return for a second session with the opposite study condition (THC or placebo) one week later. Both sessions follow the same procedures. Participants are fully debriefed after completing the study.

Perceptions of Proposed Warnings for Cannabis Edibles Packaging

The purpose of this study is to compare a delayed-effects warning to an expanded warning developed in previous experiments on knowledge, harm perceptions, and willingness to try cannabis edibles. Additionally, this study will examine the effects of a corresponding icon on attention to and recall of the warning.

Examining the Role of Tolerance on Dose-dependent Effects of Acute THC on Oculomotor and Cognitive Performance

The purpose of this research is to determine the extent to which oculomotor function accurately detects THC-impairment, if cannabis use experience impacts this detection threshold, and to examine how the oculomotor index corresponds to a measure of sustained attention. A double-blind, placebo-controlled, within-subjects crossover design will be used to examine the dose-effects of THC (0, 5mg, 30mg) on oculomotor performance tasks and a sustained attention task in frequent and infrequent cannabis users. Results from the study will advance the investigators' understanding of the effect of THC and cannabis use frequency on oculomotor function and sustained attention, and will directly inform the validity of the investigators' oculomotor platform for identifying acute THC- induced impairment in frequent and infrequent users.

Culturally Adapted EAET-H for Chronic Pain Patients Using Medical Cannabis in Israel - A Pilot Study

The goal of this clinical trial is to evaluate whether a culturally adapted group-based emotional therapy named "Emotional Awareness and Expression Therapy" can help reduce chronic pain and improve emotional well-being in Israeli adults who suffer from chronic musculoskeletal pain and are treated with medical cannabis. Researchers will compare patients who receive the emotional therapy along with their usual care to patients who receive usual care only, to see if the therapy leads to better outcomes in pain, mental health, and daily functioning. Participants will attend a weekly 1.5-hour group therapy session for 8 weeks; Take part in group discussions and emotional processing exercises; Complete questionnaires about pain levels, mood, sleep, and quality of life; Continue their usual medical treatment as prescribed by their doctors.

Evaluating the Impact of Psychotherapeutic Advertising Claims on Cannabis Purchasing

In the U.S., legal cannabis is frequently advertised as an effective treatment for mental health problems such as anxiety and depression-particularly online. States that have legalized cannabis have not implemented regulations to address this type of advertising. This project aims to investigate the influence of psychotherapeutic advertising claims (PAC) and mental health warning labels (WL) on online cannabis purchasing behaviors among light-to-moderate cannabis users with symptoms of depression and/or anxiety. The specific aims are to determine whether PAC increases cannabis purchasing intentions and whether a mental health WL can mitigate this effect. A realistic online cannabis shopping experience will be simulated using the digital Platform for Online Evaluation of Marijuana Marketing and Sales (POEMMS). The study will employ a between-subjects experimental design by randomizing 2,000 participants to one of four online stores that vary in PAC and WL content: (1) a control claims (CC)-only store, (2) a PAC store, (3) a WL store, and (4) a PAC + WL store. Participants will browse and select items as if making real purchases. Analyses will examine three primary outcomes to determine the influence of PAC and WL on purchasing behaviors: (1) total milligrams of THC purchased, (2) average potency (%THC) of products, and (3) overall number of products purchased. The long-term objective is to inform evidence-based cannabis policy and regulatory strategies by understanding the impact of cannabis marketing on vulnerable populations. This research is relevant to public health by addressing the potential risks associated with misleading cannabis marketing, which may lead to increased use and exacerbation of mental health symptoms among individuals with depression and anxiety. The project leverages a multidisciplinary team with expertise in addiction, mental health, epidemiology, and digital health technology. The findings have the potential to inform the development of targeted interventions and policies to reduce harms associated with cannabis advertising-ultimately contributing to better health outcomes and more effective regulation.

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.

Study on Regulated Cannabis Sales in Pharmacies

Though regulated cannabis sales are increasing, little is known about the individual health effects of cannabis regulation. Data from countries with a regulated market can be used to test the effect of regulation on the price of cannabis in the illicit market, and to explore its effect on social and health outcomes at the societal level, but strength of evidence for individual health and social outcomes is more limited because it must be aggregated on a state or country level. Data on individual and social outcomes should include baseline measurements before and outcome measurements after regulations changed. In this context, randomized-controlled trials are the least biased source of data on the effects of interventions. The SCRIPT study aims to investigate the individual health and social impact on recreational cannabis users who are allowed to purchase authorized, regulated cannabis from Swiss pharmacies compared to users who buy cannabis on the illicit market. Participants are randomly allocated in one of the two groups and followed-up for 6 months. After 6 months, all participants are allowed to participate in the intervention and the cohort is followed up for another 18 months. The intervention includes various offers: Participants can choose between cannabis sorts and delivery methods, and they are encouraged to shift from smoking cannabis to vaping cannabis-containing e-liquids, vaporizing cannabis blossoms or using oral cannabis. Vaping / vaporizing electronic devices are also recommended. At the same time, pharmacists offer opportunistic smoking cessation and problematic cannabis, alcohol use and further drug use counseling that conforms to motivational interviewing principles. The SCRIPT study adheres to rigorous quality criteria for the production and storage of regulated cannabis products. Only vaping / vaporizing electronic devices which are validated to reduce exposure to toxicants compared to cannabis smoking are recommended.

Environment and Lung Cancer

Cannabis is the most consumed drug in the world and the French are the main consumers in Europe. The most recognized effects of cannabis on human health are of a neuro-psychic nature. The medical literature on the effects of cannabis on the lung in general, and on lung carcinogenesis in particular, is most often reassuring (Tashkin, Chest 2018; Zhang, Int J Cancer 2015; Ghasemiesfe JAMA Netw. Open. 2019), despite the fact that the concentration of carcinogens in cannabis smoke is higher than that contained in tobacco smoke (Moir, Chem. Res. Toxicol. 2008), and that cannabis smoking has been implicated in the occurrence of ENT cancers. Rather, research focuses on the therapeutic effects of cannabis, especially analgesics, and even on its possible anti-tumor virtues (Abrams, Jama Oncol. 2020). These reassuring data should, however, be viewed with a great deal of caution. On the one hand, the illegal nature of cannabis in most countries and its frequent association with tobacco consumption make studies on the subject difficult and often biased. On the other hand, the daily practice of oncologists, who observe numerous cases of advanced and rapidly progressive lung cancer occurring in young patients who are heavy users of cannabis, raises suspicion of an unrecognized role of cannabis in lung carcinogenesis. In a preliminary multicenter study on French patients under 50 years of age operated for primary lung cancer (Betser, ERJ 2021), we demonstrated that cannabis consumption was extremely frequent, concerning 43% of patients, but mentioned in patients' medical records only in 4 out of 10 cases, while the smoking status was always noted. In addition, by comparing people who smoke cannabis (always here associated with tobacco) to patients who only smoke tobacco or to non-smokers, we identified a different profile of lung cancers, with more poorly differentiated tumors, presenting at a more advanced stage (more T3-T4 versus T1-T2) requiring more complex surgery, and mostly located in the upper lobes of the lung. Similar research work is currently underway at Gustave Roussy (Dr Pradere-Dr Planchard, Villejuif, France) on patients with metastatic lung cancer, with a focus on overall survival and molecular profile.

Effects of Pregnancy-associated Hormones on THC Metabolism in Women

Cannabis use is prevalent among pregnant women, but the effects of use on both the developing fetus and pregnant woman are unknown. Importantly, drug exposure could be influenced by the impact of pregnancy-associated hormones on the metabolism of tetrahydrocannabinol (THC), the main psychoactive component of cannabis. The goal of this study is to determine whether cortisol and estradiol - hormones that rise dramatically during pregnancy - increase the clearance of dronabinol (THC) in reproductive age women to simulate the pregnant state. The collected data will then be used to predict the time course and magnitude of changes in THC metabolism in pregnant women, particularly with gradually increasing estradiol and cortisol concentrations that evolve over the course of pregnancy. The overall objective of this study is to better understand the effects of THC use during pregnancy on the health of the pregnant woman and developing fetus.

Characterization of Endocannabinoid and Endogenous Opioid Levels in Adolescents With Cannabis Use Disorder

This project seeks to learn more about the effects of cannabis use on the endocannabinoid system and endogenous opioid systems in adolescents to address a fundamental gap in knowledge and identify biomarkers that may help distinguish youth who relapse from youth who remain sober.