A Brief Intervention for Cannabis Use

Cannabis Use Disorder Clinical Trial

Official title:

Development of a Novel Cannabis Brief Intervention for Frequently-Using Emerging Adults: Pilot Randomized Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06395389
• Other study ID #: Pro00133931
• Secondary ID: K12DA031794
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: June 2025

Study information

• Verified date: May 2024
• Source: Medical University of South Carolina
• Contact: Kathryn Gex, Ph.D.
• Phone: (843) 792-4904
• Email: soltisk[@]musc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: June 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Cannabis Use Disorder
• Marijuana Abuse

Intervention

Behavioral:
• Health Education (HealthEdu)
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.
• Values in Action (VIA)
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Institute on Drug Abuse (NIDA)

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Comprehensive Marijuana Motives Questionnaire (CMMQ)	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
Other	Protective Behavioral Strategies - Marijuana (PBSM)	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
Other	Consideration of Future Consequences Scale (CFCS)	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
Other	The Adolescent Reinforcement Survey Schedule - Substance Use Version (ARSS-SUV)	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
Primary	Timeline Followback (TLFB)	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	Marijuana Assessment of Problems Inventory (MAPI)	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
Secondary	Mini International Neuropsychiatric Interview (MINI) Cannabis Use Disorder Module	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
Secondary	Oral Fluid Biospecimen Assay	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