Recruiting

Cannabis

Sponsor:

Massachusetts General Hospital

Code:

NCT06576076

Conditions

Cannabis Use

Depression

Suicidal Ideation

Adolescent Behavior

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Not accepted

Interventions

Contingency management for cannabis abstinence

Study Details

Brief summary:

The goal of this study is to disentangle relationships between acute cannabis use and withdrawal on proximal depression and suicide risk and recovery in adolescents ages 12-18 years by incorporating time-varying patterns of substance use, mood, and SI. This project aims to guide the development of scalable, individualized, accessible, and affordable interventions aimed to reduce depression and suicide risk among adolescents.

Conditions

Cannabis Use

Depression

Suicidal Ideation

Adolescent Behavior

Study ID

NCT06576076

Start date

Feb 18, 2025

Status verified date

Feb, 2026

Completion date

Apr 30, 2029

Anticipated

Primary completion date

Apr 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Ages 12-18;
  • Current daily or near daily cannabis use (i.e., use ≥ 4 days per week on average; Timeline Followback);
  • Score ≥ 5 on PHQ-9;
  • Access to an internet-capable smartphone (iOS or Android);
  • Provision of at least 1 collateral contact for risk monitoring;
  • Provision of informed assent (or consent if 18 years or older) and parent/guardian consent if <age 18;
  • Greater than 50% response rate to EMA prompts during the first EMA phase;
  • No immediate plan to discontinue cannabis use in the next 3 months;
  • Positive toxicology result for cannabis on baseline urinalysis.

Exclusion Criteria:

  • Any factor that impairs ability to comprehend and effectively participate, including acute intoxication at time of consent;
  • Cannabis use >4 times/day on average (to maximize likelihood of capturing mood and SI during non-use times);
  • Inability to speak/write English fluently;
  • Gross cognitive impairment, for example due to florid psychosis, intellectual disability, developmental delay, or neurodegenerative disease;
  • Current epilepsy diagnosis;
  • Individuals who are under the legal protection of the government or state (wards of the state);
  • Response of "No" to the knowledge check question regarding EMA suicidality response time;
  • Inability to wear Fitbit device.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Cannabis Abstinence (CB-Abst)

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.

no intervention: Cannabis Monitoring (CB-Mon)

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.

no intervention: Pre-intervention Pooled Groups (EMA Phase 1 Only)

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).

Interventions

Contingency management for cannabis abstinence

Those randomized to the abstinence condition (CB-Abst) will be incentivized using an escalating reinforcement schedule for eight weeks of cannabis abstinence.

Primary outcome measure

  • Aim 1: Cannabis use in the last hour [ Time Frame: Weeks 1 - 2 (EMA Phase 1; Baseline Use as Usual) ]
  • Aim 1: Motivation to use cannabis to improve mood collected [ Time Frame: Weeks 1 - 2 (EMA Phase 1; Baseline Use as Usual) ]
  • Aim 2: Depleted mood [ Time Frame: Weeks 1 - 3, Week 10 (EMA Phase 2-3; Randomized Withdrawal then Sustained Abstinence) ]
  • Aim 2: Negative cognitive impact [ Time Frame: Weeks 1 - 3, Week 10 (EMA Phase 2-3; Randomized Withdrawal then Sustained Abstinence) ]
  • Aim 2: Negative activation [ Time Frame: Weeks 1 - 3, Week 10 (EMA Phase 2-3; Randomized Withdrawal then Sustained Abstinence) ]
  • Aim 2: Passive suicidal ideation [ Time Frame: Weeks 1 - 3, Week 10 (EMA Phase 2-3; Randomized Withdrawal then Sustained Abstinence) ]
  • Aim 2: Suicidal urges [ Time Frame: Weeks 1 - 3, Week 10 (EMA Phase 2-3; Randomized Withdrawal then Sustained Abstinence) ]
  • Aim 2: Non-suicidal self-injury urges [ Time Frame: Weeks 1 - 3, Week 10 (EMA Phase 2-3; Randomized Withdrawal then Sustained Abstinence) ]

Central Contacts and Locations

Central contacts

Randi M Schuster, PhD

617-643-6673rschuster@mgh.harvard.edu

Julia Jashinski, MSW

617-643-1984jjashinski@mgh.harvard.edu

Locations

Massachusetts General Hopsital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Randi M Schuster, PhD

617-643-6673rschuster@mgh.harvard.edu

Julia Jashinski, MSW

617-643-1984jjashinski@mgh.harvard.edu

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Mar 3, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-03-03.