Clinical trial NCT06395389: A Brief Intervention for Cannabis Use
Official title: Development of a Novel Cannabis Brief Intervention for Frequently-Using Emerging Adults: Pilot Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cannabis Use Disorder
Keywords: Early intervention
Emerging adults
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2024-05-02
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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).

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.

Eligibility criteria: 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)
* Submit a positive urine cannabinoid test during the Intake Visit

Exclusion Criteria:

* 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 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

Primary outcomes:
measure: Timeline Followback (TLFB)
timeFrame: Baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up
Secondary outcomes:
measure: Marijuana Assessment of Problems Inventory (MAPI)
timeFrame: Baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up
measure: Mini International Neuropsychiatric Interview (MINI) Cannabis Use Disorder Module
timeFrame: Baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up
measure: Oral Fluid Biospecimen Assay
timeFrame: Baseline, 2-week follow-up, 1-month follow-up, 3-month follow-up, 6-month follow-up
Other outcomes:
measure: Comprehensive Marijuana Motives Questionnaire (CMMQ)
timeFrame: Baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up
measure: Protective Behavioral Strategies - Marijuana (PBSM)
timeFrame: Baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up
measure: Consideration of Future Consequences Scale (CFCS)
timeFrame: Baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up
measure: The Adolescent Reinforcement Survey Schedule - Substance Use Version (ARSS-SUV)
timeFrame: Baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Kathryn Gex, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: