Brief Intervention for Cannabis Use Disorder

(Bloom Trial)

Overseen By Kathryn Gex, Ph.D.

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Medical University of South Carolina

Disqualifiers: Substance use treatment, Severe alcohol use, SUD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 2 weeks

62 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two brief interventions to assist young adults who might use cannabis in unhealthy ways. One intervention, Values in Action (VIA), emphasizes personal values and goals. The other, Health Education (HealthEdu), offers tips on sleep, nutrition, stress management, and relationships. Researchers aim to determine which approach more effectively reduces potentially problematic cannabis use. Individuals who have used cannabis on most days in the past month and can provide a positive cannabis test might be suitable candidates. As an unphased trial, this study allows participants to contribute to important research that could enhance health interventions for young adults.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are currently in treatment for substance use or have severe medical or psychiatric issues, you may not be eligible to participate.

What prior data suggests that these brief interventions are safe for emerging adults?

Research has shown that the brief interventions compared in this study are generally safe. These interventions do not involve new drugs or medications; instead, they consist of discussions and advice, eliminating side effects typically associated with medications.

The Values in Action (VIA) treatment, which emphasizes personal values and goals, lacks specific data on risks because it is conversation-based. Similarly, the Health Education (HealthEdu) treatment offers advice on sleep, nutrition, and stress, which are usually safe topics.

In summary, both approaches are considered well-tolerated, as they involve guidance and conversation without introducing any new substances into the body. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Brief Intervention for Cannabis Use Disorder because it takes a personalized approach to help individuals align their cannabis use with their personal values and goals. Unlike standard treatments that focus on abstinence or reducing usage through medication, the Values in Action (VIA) method engages individuals in meaningful discussions about their values, reasons for using cannabis, and strategies to live in accordance with their values. Meanwhile, the Health Education (HealthEdu) component offers practical advice on improving overall wellness, such as sleep, nutrition, and stress management. This holistic approach could provide a more tailored and empowering experience for individuals seeking to adjust their cannabis use.

What evidence suggests that this trial's interventions could be effective for cannabis use disorder?

This trial will compare two brief interventions for cannabis use disorder. Studies have shown that short programs can help young adults reduce their cannabis use. One study found that participants in a similar program used cannabis much less over a year. In this trial, participants in the "Bloom" arm will receive a personalized discussion of values and goals, reasons for cannabis use, and strategies to align with values and achieve goals. Research also shows that methods like the Values in Action (VIA) approach effectively reduce problems related to cannabis use. Meanwhile, participants in the "Health Education (HealthEdu)" arm will receive recommendations and advice on sleep hygiene, nutrition, physical activity, stress, and relationships. These findings suggest that short programs focusing on personal values and lifestyle changes can be promising for managing cannabis use. ^{1 6 7 8 9}

Who Is on the Research Team?

Kathryn Gex, Ph.D.

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

This trial is for young adults aged 18-25 who have used cannabis on at least 20 of the past 30 days and tested positive for cannabinoids in their urine. They must have completed an intake visit within the last month.

Inclusion Criteria

Completion of an Intake Visit (PRO #94743) in the past 30 days

Submission of a positive urine cannabinoid test during the Intake Visit

Self-report cannabis use on at least 20 days of the past 30 days

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo two brief intervention sessions targeting cannabis use, each lasting 40-50 minutes, separated by 1 week

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with assessments at 1-month, 3-month, and 6-month intervals

6 months

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Health Education (HealthEdu)
• Values in Action (VIA)

Trial Overview The study compares two short counseling programs, Health Education (HealthEdu) and Values in Action (VIA), to see which one better helps reduce problematic cannabis use. Participants will attend two sessions a week apart and be followed up with three times.

How Is the Trial Designed?

Group I: Bloom Experimental Treatment 1 Intervention

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

Group II: Health Education (HealthEdu) Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

A web-based intervention called eCHECKUP TO GO-marijuana significantly reduced marijuana use among students who were already taking steps to change their behavior, as indicated by high scores on the Action dimension of the Readiness-to-Change Questionnaire.

The study involved 123 monthly marijuana-using students and found that those in the intervention group reported fewer days of use at the 3-month follow-up compared to a control group, highlighting the intervention's potential effectiveness for motivated individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Readiness-to-change as a moderator of a web-based brief intervention for marijuana among students identified by health center screening. Palfai, TP., Tahaney, K., Winter, M., et al.[2018]

Adolescent cannabis use can lead to negative effects on development, cognition, and mental health, making it crucial to address this behavior through effective interventions.

Current strategies for managing cannabis use disorder in adolescents show only modest short-term effects, and the referral to treatment is often hindered by a lack of available resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Substance Use Screening, Brief Intervention, and Referral to Treatment in Pediatric Primary Care, School-Based Health Clinics, and Mental Health Clinics. Calihan, JB., Levy, S.[2023]

Adolescent cannabis use can lead to negative effects on development, cognition, and mental health, making it crucial to address this behavior through effective interventions.

Current strategies for managing cannabis use in adolescents, including screening and brief interventions, show only modest short-term effectiveness, and there are significant limitations in resources for referring adolescents to treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Substance Use Screening, Brief Intervention, and Referral to Treatment in Pediatric Primary Care, School-Based Health Clinics, and Mental Health Clinics. Calihan, JB., Levy, S.[2023]

A study involving 134 young, high-frequency cannabis users showed that Brief Interventions (BIs) led to significant long-term reductions in risky behaviors, such as deep inhalation and driving after cannabis use, which were maintained over 12 months.

The findings suggest that BIs can be an effective public health tool for reducing risks associated with cannabis use, as the positive effects observed at 3 months continued to be evident a year later.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

12-month follow-up of an exploratory 'brief intervention' for high-frequency cannabis users among Canadian university students. Fischer, B., Jones, W., Shuper, P., et al.[2022]

Only 30% of patients with a new cannabis use disorder (CUD) diagnosis initiated treatment, and just 2.1% both initiated and engaged in treatment, indicating a significant gap in care for individuals with CUD.

Patients diagnosed in addiction treatment settings had the highest rates of treatment initiation (25%) and engagement (40.9%), suggesting that the setting of diagnosis plays a crucial role in treatment uptake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The prevalence of Healthcare Effectiveness Data and Information Set (HEDIS) initiation and engagement in treatment among patients with cannabis use disorders in 7 US health systems. Lapham, GT., Campbell, CI., Yarborough, BJH., et al.[2020]

This systematic review aims to evaluate the effectiveness of brief interventions for cannabis use among emerging adults (ages 18-25), a group that is increasingly using cannabis and may benefit from increased awareness and motivation to change their habits.

The review will analyze various study designs and outcomes related to cannabis use, including mental health and academic performance, to provide evidence-based recommendations for post-secondary institutions on implementing effective intervention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief interventions for cannabis use in emerging adults: protocol for a systematic review, meta-analysis, and evidence map. Halladay, J., Petker, T., Fein, A., et al.[2023]

In a randomized controlled trial involving 100 male patients with cannabis use disorder, a brief intervention led to a significant reduction in the number of days cannabis was used compared to simple advice over a 12-week period.

While both groups showed improvements in dependence severity, the brief intervention group demonstrated a more effective reduction in cannabis use, suggesting it could be a valuable addition to routine management for cannabis use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of brief intervention for patients with cannabis use disorder. Shekhawat, AS., Mathur, R., Sarkar, S., et al.[2023]

In a study of 1780 unique visits for patients with substance use disorders (SUD), 17.5% left the hospital against medical advice (AMA), highlighting a significant challenge in managing these patients.

The average length of stay for patients evaluated by the harm reduction (HR) team was 6.6 days, compared to just 4.0 days for those who left AMA, suggesting that HR strategies may improve patient retention and care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using a Harm Reduction Approach to Treat Inpatients With Substance Use Disorders. Shields, LBE., LaRocco, M., Young, MW., et al.[2023]

Among individuals with cannabis use disorder (CUD), 40.15% had visited the emergency department and 10.04% had been hospitalized in the past year, indicating significant healthcare utilization.

Factors such as severe alcohol use disorder, female sex, Black race, low income, and major depressive episodes were linked to higher odds of healthcare utilization, suggesting that targeted screening and intervention efforts should focus on these groups to improve treatment engagement for CUD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Problem alcohol use and healthcare utilization among persons with cannabis use disorder in the United States. John, WS., Wu, LT.[2022]

Citations

1. withpower.com withpower.com/trial/phase-cannabis-use-disorders-4-2024-4085b

Brief Intervention for Cannabis Use Disorder (Bloom Trial) The purpose of this study is to compare two brief interventions targeting potentially problematic cannabis use in emerging adults (ages 18-25).

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4880536/

Treatment of Cannabis Use Disorder: Current Science and ... At 9- and 15-month follow-up, the 9-session intervention showed greater reductions in days of use, dependence symptoms, and abuse symptoms compared to the 2- ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3984620/

A Randomized Controlled Trial Testing the Efficacy ... Compared with controls, CBI participants had significantly lower rates of any cannabis use over 12 months (24.2%, 16.8%, respectively, p<.05), frequency of ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/add.70084

Effectiveness and safety of psychosocial interventions for ... Aim To evaluate the effectiveness, safety and cost-effectiveness of psychosocial interventions for cannabis use disorder (CUD).

5. sciencedirect.com sciencedirect.com/science/article/pii/S221214472400053X

Effectiveness of acceptance and commitment therapy for ... Three previous systematic reviews have concluded that ACT has a positive effect on treatment outcomes for substance use disorders. Specifically, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8655458/

Cannabis use and cannabis use Disorder - PMC In 1992, the lifetime risk of dependence among those who had ever tried cannabis was estimated at 9%, which was lower than the risks for tobacco (32%), heroin ( ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41025421/

Pharmacotherapies for cannabis use disorder Objectives: To assess the effectiveness and safety of pharmacotherapies as compared with each other, placebo or no pharmacotherapy (supportive ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0955395924003062

Clinical and public safety risks associated with cannabis ... We recorded clinical and public safety outcomes (i.e., mental health deterioration, length of stay in the forensic system, rates of hospital readmission, ...

9. mdpi.com mdpi.com/2076-3425/14/3/227

Treatments for Cannabis Use Disorder across the Lifespan For instance, a study reports higher rates of violence and self-harm among patients with comorbid cannabis use disorders as compared to non- ...