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A Brief Intervention for Cannabis Use

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06395389
Acronym
Bloom
Enrollment
62
Registered
2024-05-02
Start date
2024-10-18
Completion date
2029-05-01
Last updated
2026-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cannabis Use Disorder

Keywords

Early intervention, Emerging adults

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).

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.

Interventions

BEHAVIORALBloom

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.

BEHAVIORALHealth 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 stress and social connection.

Sponsors

Medical University of South Carolina
Lead SponsorOTHER
National Institute on Drug Abuse (NIDA)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
No

Inclusion criteria

1. Ages 18-25 2. Self-Report report cannabis use on at least 20 days of the past 30 days 3. Submit a positive urine cannabinoid test

Exclusion criteria

1. Currently engaged in substance use treatment for any type of substance use or currently treatment seeking 2. History of substance use treatment for any type of substance 3. 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) 4. 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) 5. Significant risk of suicide or homicide 6. Currently pregnant or breastfeeding

Design outcomes

Primary

MeasureTime frameDescription
Timeline Followback (TLFB)Baseline, 1-month follow-up, 3-month follow-up, 6-month follow-upThe 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

MeasureTime frameDescription
Marijuana Assessment of Problems Inventory (MAPI)Baseline, 1-month follow-up, 3-month follow-up, 6-month follow-upThis 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 ModuleBaseline, 1-month follow-up, 3-month follow-up, 6-month follow-upThis 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 AssayBaseline, 2-week follow-up, 1-month follow-up, 3-month follow-up, 6-month follow-upThis 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.

Countries

United States

Contacts

CONTACTKathryn Gex, Ph.D.
soltisk@musc.edu(843) 792-4904
PRINCIPAL_INVESTIGATORKathryn Gex, Ph.D.

Medical University of South Carolina

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 10, 2026