- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06395389
A Brief Intervention for Cannabis Use
May 1, 2024 updated by: Kathryn Gex, Medical University of South Carolina
Development of a Novel Cannabis Brief Intervention for Frequently-Using Emerging Adults: Pilot Randomized Trial
The purpose of this study is to compare two brief interventions targeting potentially problematic cannabis use in emerging adults (ages 18-25).
Brief interventions are two 40-50 minute sessions separated by 1 week.
Eligible emerging adults will complete a detailed cannabis assessment (biological and self-report), followed by one of the two brief interventions, and three follow-up assessments: one immediately after the second session and at 1- and 3-months post-intervention.
Assignment to the brief intervention is random.
Salivary samples will be collected at baseline, post-intervention, and both follow-ups, for a total of 4 samples, to be tested for tetrahydrocannabinol (THC) and cannabidiol (CBD).
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Cannabis is the most widely used federally illicit substance among emerging adults (age 18-25) in the U.S., and frequent cannabis use is associated with myriad long-term health, social, and academic/occupational consequences.
Despite this, rates of perceived risk of daily/regular cannabis use have steadily declined over the past two decades, and this is associated with increased frequency of use, a risk for for Cannabis Use Disorder (CUD).
Brief interventions (BIs) are among the most frequently used approaches for addressing problematic or potentially problematic substance use in non-treatment-seeking adolescents and young adults.
Although several cannabis brief interventions have been developed and tested to date, meta-analyses indicate that the efficacy of these interventions for emerging adults is mixed and the quality of studies is low, suggesting that novel approaches and rigorous methodology are necessary to improve efficacy.
The current study will evaluate the feasibility, acceptability, and preliminary efficacy of a novel cannabis BI for emerging adults who frequently use cannabis.
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Kathryn Gex, Ph.D.
- Phone Number: (843) 792-4904
- Email: soltisk@musc.edu
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Ages 18-25
- Self-Report report cannabis use on at least 20 days of the past 30 days.
- Completion of an Intake Visit (PRO #94743) in the past 30 days
- Submit a positive urine cannabinoid test during the Intake Visit
Exclusion Criteria:
- Currently engaged in substance use treatment for any type of substance use
- Severe alcohol use disorder or presence of any substance use disorder (SUD) requiring a higher level of care
- Significant or acutely unstable medical or psychiatric problems (i.e., psychosis, mania) that would contraindicate research procedures, interfere with safety, compromise data integrity, or preclude consistent study participation
- Significant risk of suicide or homicide
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Health Education (HealthEdu)
Brief intervention providing recommendations/advice for good sleep hygiene, nutrition and physical activity, financial and other related life skills.
|
The Health Education condition is a 2-session brief intervention with each session lasting 40-50 minutes and separated by about 1 week (5-10 days).
The first session focuses on providing in-depth information on good sleep hygiene and habits to improve sleep and information on positive eating habits, nutrition, and physical activity/functional exercise.
The second session focuses on providing information about good financial health and related life skills.
Other Names:
|
Experimental: Values in Action (VIA)
Brief intervention providing personalized discussion of values/goals, reasons for cannabis use, and strategies to help live in line with values and achieve goals.
|
VIA is a 2-session brief intervention with each session lasting 40-50 minutes and separated by about 1 week (5-10 days).
The first session encourages participants to ask themselves what is important to them.
This discussion emphasizes identifying values and ways to live in line with their values, as well as why they use cannabis and providing personalized feedback related to their reasons for use.
The second session asks participants to reflect on information from session one and consider what they would like to do next to live in line with their values.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Timeline Followback (TLFB)
Time Frame: Baseline, 1-month follow-up, 3-month follow-up
|
The TLFB is a calendar based assessment that is able to capture the frequency and quantity of substance use and other measurable behaviors.
Responders identify anchor dates to facilitate recall of days in which substances were used.
|
Baseline, 1-month follow-up, 3-month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Marijuana Assessment of Problems Inventory (MAPI)
Time Frame: Baseline, 1-month follow-up, 3-month follow-up
|
This is a 23-item assessment of the frequency in which problems or negative consequences associated with cannabis use have occurred.
For each item, participants select 0 times, 1-2 times, 3-5 times, 6-10 times, or 10+ times in the past month.
Higher scores on this inventory indicate a higher frequency of problems or consequences experienced.
|
Baseline, 1-month follow-up, 3-month follow-up
|
Mini International Neuropsychiatric Interview (MINI) Cannabis Use Disorder Module
Time Frame: Baseline, 1-month follow-up, 3-month follow-up
|
This is a 12-item semi-structured clinician interview that assesses diagnostic symptom criteria of cannabis use disorder (CUD) from the Diagnostic and Statistical Manual 5th Edition (DSM-5).
Clinicians select either 'yes' or 'no' for the presence of the symptom.
|
Baseline, 1-month follow-up, 3-month follow-up
|
Oral Fluid Biospecimen Assay
Time Frame: Baseline, 2-week follow-up, 1-month follow-up, 3-month follow-up
|
This is a relatively brief objective assessment of recent cannabis use that is collected through mouth swab and is tested at Forensic Fluids Laboratory for the presence of delta-9 tetrahydrocannabinol (THC), delta-8 THC, and cannabidiol (CBD) using a cut-off of 1 nanogram/liter.
|
Baseline, 2-week follow-up, 1-month follow-up, 3-month follow-up
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comprehensive Marijuana Motives Questionnaire (CMMQ)
Time Frame: Baseline, 1-month follow-up, 3-month follow-up
|
This is a 44-item measure capturing the various reasons why the individual uses cannabis, including for enjoyment/enhancement, coping, social anxiety, sleep, celebration, boredom, conformity, expansion, and others.
For each item, participants select 1 (almost never/never), 2 (some of the time), 3 (half the time), 4 (most of the time), or 5 (almost always/always).
Higher average scores indicate more reasons for cannabis use / using cannabis more often for identified reasons.
|
Baseline, 1-month follow-up, 3-month follow-up
|
Protective Behavioral Strategies - Marijuana (PBSM)
Time Frame: Baseline, 1-month follow-up, 3-month follow-up
|
This is a 36-item measure that assesses the use of different cognitive and behavioral strategies that are intended to minimize harms or negative consequences associated with cannabis use.
For each item, participants select 1 (Never), 2 (Rarely), 3 (Occasionally), 4 (Sometimes), 5 (Usually), or 6 (Always).
Higher scores indicate more frequent use of strategies to reduce the risk of harm or negative consequences from cannabis use.
|
Baseline, 1-month follow-up, 3-month follow-up
|
Consideration of Future Consequences Scale (CFCS)
Time Frame: Baseline, 1-month follow-up, 3-month follow-up
|
This is a 12-item scale that assesses how characteristic or uncharacteristic it is for the individual to take into account the future consequences of an action or choice made in the present moment.
Participants rate each item from 1 to 5: 1 (extremely uncharacteristic), 2 (somewhat uncharacteristic), 3 (uncertain), 4 (somewhat characteristic), 5 (extremely characteristic).
Higher scores indicate a greater consideration of future consequences.
|
Baseline, 1-month follow-up, 3-month follow-up
|
The Adolescent Reinforcement Survey Schedule - Substance Use Version (ARSS-SUV)
Time Frame: Baseline, 1-month follow-up, 3-month follow-up
|
This is a 35-item assessment of day-to-day activities that individuals engage in with or without the use of substances (in this case cannabis) and the extent to which they enjoyed participating in the activity with or without substance use.
For each frequency item, participants select 0 (not engaged), 1 (once a week or less), 2 (2-4 times per week), 3 (about once a day), or 4 (more than once a day).
For each enjoyment item, participants select (0 (unpleasant/neutral), 1 (mildly pleasant), 2 (moderately pleasant), 3 (very pleasant), or 4 (extremely pleasant).
A cross-product of frequency and enjoyment is created for each item to calculate final scores of substance-free reinforcement and substance-related reinforcement.
A reinforcement ratio is then calculated for substance-free and substance-related activities by dividing each score from the sum of both scores (i.e., substance-free / (substance-free + substance-related); or substance-related / (substance-free + substance-related)).
|
Baseline, 1-month follow-up, 3-month follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Kathryn Gex, Ph.D., Medical University of South Carolina
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
May 1, 2024
Primary Completion (Estimated)
May 1, 2025
Study Completion (Estimated)
June 1, 2025
Study Registration Dates
First Submitted
April 22, 2024
First Submitted That Met QC Criteria
April 29, 2024
First Posted (Actual)
May 2, 2024
Study Record Updates
Last Update Posted (Estimated)
May 3, 2024
Last Update Submitted That Met QC Criteria
May 1, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00133931
- K12DA031794 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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