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Behavioral Intervention

Contingency Management for Depression and Cannabis Use (CLEAR Trial)

N/A

Recruiting

Led By Randi M Schuster, PhD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Greater than 60% response rate to EMA prompts during the first EMA phase

Ages 12-18

Must not have

Inability to speak/write English fluently

Gross cognitive impairment, for example due to florid psychosis, intellectual disability, developmental delay, or neurodegenerative disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks 1 - 3, week 10 (ema phase 2-3; randomized withdrawal then sustained abstinence)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to understand how using cannabis and going through withdrawal affects depression and suicide risk in adolescents aged 12-18. They will look at how substance use and mood change over time to develop better

Who is the study for?

This trial is for adolescents aged 12-18 who experience depression or suicidal thoughts and use cannabis. It aims to understand how cannabis affects their mood and risk of suicide, with the goal of creating better interventions.

What is being tested?

The study tests a strategy called 'contingency management' which rewards individuals for abstaining from cannabis use, to see if it helps reduce depression and suicidal thoughts in youth.

What are the potential side effects?

Since this trial involves behavioral intervention rather than medication, there are no direct side effects like those seen with drugs. However, participants may experience changes in mood or behavior.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I responded to more than 60% of the prompts in the first phase.

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I am between 12 and 18 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot speak or write in English fluently.

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I do not have severe cognitive issues like major psychosis or dementia.

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I have been diagnosed with epilepsy.

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I am able to understand and participate in the study without any impairment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 1 - 3, week 10 (ema phase 2-3; randomized withdrawal then sustained abstinence)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weeks 1 - 3, week 10 (ema phase 2-3; randomized withdrawal then sustained abstinence)

This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 1 - 3, week 10 (ema phase 2-3; randomized withdrawal then sustained abstinence) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Aim 1: Cannabis use in the last hour

Aim 1: Motivation to use cannabis to improve mood collected

Aim 2: Depleted mood

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Cannabis Abstinence (CB-Abst)Experimental Treatment1 Intervention

Those randomized to the abstinence condition will be asked to stop using cannabis for eight weeks. They will participate in a contingency management protocol, which uses an escalating remuneration schedule to incentivize abstinence. Abstinence is confirmed biochemically via progressively decreasing values of creatinine-adjusted THCCOOH.

Group II: Cannabis Monitoring (CB-Mon)Active Control1 Intervention

Those randomized to the monitoring condition will be asked to make no changes to their cannabis use frequency or dose for the duration of the eight week study.

Group III: Pre-intervention Pooled Groups (EMA Phase 1 Only)Active Control1 Intervention

All enrolled participants will participate in approximately two weeks of EMA data collection prior to being randomized and starting intervention procedures to characterize mood during baseline use as usual (CB-Abst or CB-Mon).

0 / 6Eligibility criteria met