About this 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 four follow-up assessments: one immediately after the second session and at 1-, 3-, and 6-months post-intervention. Assignment to the brief intervention is random. Salivary samples will be collected at baseline, post-intervention, and all follow-ups, for a total of 5 samples, to be tested for tetrahydrocannabinol (THC) and cannabidiol (CBD).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Ages 18-25
Self-Report report cannabis use on at least 20 days of the past 30 days
Submit a positive urine cannabinoid test
Disqualifiers
Currently engaged in substance use treatment for any type of substance use or currently treatment seeking
History of substance use treatment for any type of substance
Severe alcohol use disorder or indication of any substance use disorder requiring a higher level of care (AUDIT score ≥14 or DUDIT score ≥2 for women, ≥6 for men)
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 (Screening psychosis score =7)
Trial design
Parallel
Treatments tested in this trial
Health Education (HealthEdu)
BehavioralThe 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 stress and social connection.
Bloom
BehavioralBloom 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
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.
Other outcomes
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.
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.
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.
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)).
Sponsors and contacts
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Medical University of South Carolina
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator