A Brief Intervention for Cannabis Use

NCT06395389 | Recruiting

• 2 other identifiers: Pro00133931K23DA058077
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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 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).

Conditions

Cannabis Use Disorder

Keywords

Early intervention; Emerging adults

Outcome Measures

Primary Outcomes (1)

• 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, 6-month follow-up

Secondary Outcomes (3)

• Marijuana Assessment of Problems Inventory (MAPI)

  Baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up

• Mini International Neuropsychiatric Interview (MINI) Cannabis Use Disorder Module

  Baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up

• Oral Fluid Biospecimen Assay

  Baseline, 2-week follow-up, 1-month follow-up, 3-month follow-up, 6-month follow-up

Other Outcomes (4)

• Comprehensive Marijuana Motives Questionnaire (CMMQ)

  Baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up

• Protective Behavioral Strategies - Marijuana (PBSM)

  Baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up

• Consideration of Future Consequences Scale (CFCS)

  Baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up

Study Arms (2)

Health Education (HealthEdu)

ACTIVE COMPARATOR

Brief intervention providing recommendations/advice for good sleep hygiene, nutrition and physical activity, stress, and relationships.

Behavioral: Health Education (HealthEdu)

Bloom

EXPERIMENTAL

Brief intervention providing personalized discussion of values/goals, reasons for cannabis use, and strategies to help live in line with values and achieve goals.

Behavioral: Bloom

Interventions

Health Education (HealthEdu) BEHAVIORAL

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 stress and social connection.

Also known as: HealthEdu

Health Education (HealthEdu)

Bloom BEHAVIORAL

Bloom 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.

Bloom

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Ages 18-25
• Self-Report report cannabis use on at least 20 days of the past 30 days
• Submit a positive urine cannabinoid test

You may not qualify if:

• 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)
• Significant risk of suicide or homicide
• Currently pregnant or breastfeeding

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): collaborator
• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

Study Officials

• Kathryn Gex, Ph.D.

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathryn Gex, Ph.D.

CONTACT

(843) 792-4904; soltisk@musc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor-Faculty

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: May 2, 2024
• Study Start: October 18, 2024
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2029
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

US (1)