Cannabis, Linked Emotions, and Adolescent Risk Study

NCT06576076 | Recruiting DMC

• 2 other identifiers: 2024P0024171R01DA054145-01A1
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (8)

• Aim 1: Cannabis use in the last hour

  Responses will be collected via ecological momentary assessment based on 7-9 random prompts a day. The outcome is a binary rating as to whether cannabis was used in the last hour, either 0 (No use) or 1 (Use in the last hour). We will examine data from all participants prior to randomization to experimental arms (Pre-intervention Pooled Groups arm).

  Weeks 1 - 2 (EMA Phase 1; Baseline Use as Usual)

• Aim 1: Motivation to use cannabis to improve mood collected

  Responses will be collected via ecological momentary assessment based on 7-9 random prompts a day. We will use the subset of responses following cannabis use in the last hour. The outcome is a rating for whether cannabis was used to improve negative mood, from 1 (No, not at all) to 100 (Yes, very much). Higher ratings indicate greater motivation to use cannabis to improve negative mood. We will examine data from all participants prior to randomization to experimental arms (Pre-intervention Pooled Groups arm).

  Weeks 1 - 2 (EMA Phase 1; Baseline Use as Usual)

• Aim 2: Depleted mood

  Responses will be collected via ecological momentary assessment based on 7-9 random prompts a day. The outcome is a composite score of depleted mood computed as the average over 5 ratings each assessed on a 0 (No, not at all) - 100 (Yes, very much) scale with the following question prompt: Right now how much do you feel \[MOOD\] (sub in Sad/Self-hatred/Numb/Hopeless/Fatigued). Higher ratings indicate worse feelings of depleted mood. We will examine data for participants split between the two experimental arms (CB-Abst versus CB-Mon).

  Weeks 1 - 3, Week 10 (EMA Phase 2-3; Randomized Withdrawal then Sustained Abstinence)

• Aim 2: Negative cognitive impact

  Responses will be collected via ecological momentary assessment based on 7-9 random prompts a day. The outcome is a composite score of negative cognitive impact computed as the average over 2 ratings each assessed on a 0 (No, not at all) - 100 (Yes, very much) scale with the following question prompt: Right now how much do you feel \[MOOD\] (sub in Disinterested/Inattentive). Higher ratings indicate worse feelings of negative cognitive impact. We will examine data for participants split between the two experimental arms (CB-Abst versus CB-Mon).

  Weeks 1 - 3, Week 10 (EMA Phase 2-3; Randomized Withdrawal then Sustained Abstinence)

• Aim 2: Negative activation

  Responses will be collected via ecological momentary assessment based on 7-9 random prompts a day. The outcome is a composite score of negative activation computed as the average over 3 ratings each assessed on a 0 (No, not at all) - 100 (Yes, very much) scale with the following question prompt: Right now how much do you feel \[MOOD\] (sub in Agitated/Irritated/Anxious). Higher ratings indicate worse feelings of negative activation. We will examine data for participants split between the two experimental arms (CB-Abst versus CB-Mon).

  Weeks 1 - 3, Week 10 (EMA Phase 2-3; Randomized Withdrawal then Sustained Abstinence)

• Aim 2: Passive suicidal ideation

  Responses will be collected via ecological momentary assessment based on 7-9 random prompts a day. The outcome is a composite score of passive suicidal ideation computed as the average over 3 ratings each assessed on a 0 (No, not at all) - 100 (Yes, very much) scale with the following question prompt: Right now how strong is your \[IDEATION\] (sub in Thoughts about death/Wishing suffering could be over/Better off as dead). Higher ratings indicate worse passive suicidal ideation. We will examine data for participants split between the two experimental arms (CB-Abst versus CB-Mon).

  Weeks 1 - 3, Week 10 (EMA Phase 2-3; Randomized Withdrawal then Sustained Abstinence)

• Aim 2: Suicidal urges

  Responses will be collected via ecological momentary assessment based on 7-9 random prompts a day. The outcome is a rating to the following prompt: right now how strong is your intention to kill yourself, from 0 (No, not at all) to 100 (Yes, very much). Higher ratings indicate worse suicidal urges. We will examine data for participants split between the two experimental arms (CB-Abst versus CB-Mon).

  Weeks 1 - 3, Week 10 (EMA Phase 2-3; Randomized Withdrawal then Sustained Abstinence)

• Aim 2: Non-suicidal self-injury urges

  Responses will be collected via ecological momentary assessment based on 7-9 random prompts a day. The outcome is a rating to the following prompt: right now how strong is your desire to hurt your body, from 0 (No, not at all) to 100 (Yes, very much). Higher ratings indicate worse self-injury urges. We will examine data for participants split between the two experimental arms (CB-Abst versus CB-Mon).

  Weeks 1 - 3, Week 10 (EMA Phase 2-3; Randomized Withdrawal then Sustained Abstinence)

Study Arms (3)

Cannabis Abstinence (CB-Abst)

EXPERIMENTAL

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.

Behavioral: Contingency management for cannabis abstinence

Cannabis Monitoring (CB-Mon)

NO 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.

Pre-intervention Pooled Groups (EMA Phase 1 Only)

NO 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).

Interventions

Contingency management for cannabis abstinence BEHAVIORAL

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

Cannabis Abstinence (CB-Abst)

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Massachusetts General Hopsital

Boston, Massachusetts, 02114, United States

RECRUITING

Related Publications (1)

• Feibus I, Mahiques MB, Costello M, Potter K, Bentley KH, Hoeppner BB, Liu L, Evohr B, Yan L, Gilman J, Evins AE, Kossowsky J, Schuster RM. Characterizing proximal risk for depressive symptoms and suicidal ideation with acute cannabis use and withdrawal among adolescents using ecological momentary assessment: Study protocol. PLoS One. 2025 Dec 18;20(12):e0338790. doi: 10.1371/journal.pone.0338790. eCollection 2025.

  PMID: 41411314 DERIVED

MeSH Terms

Conditions

Depression; Suicidal Ideation; Adolescent Behavior

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Suicide; Self-Injurious Behavior

Study Officials

• Randi M Schuster, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Randi M Schuster, PhD

CONTACT

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

Julia Jashinski, MSW

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor; Director of School-Based Research and Program Development

Model Details: Following a shared two-week baseline assessment period (Arm 1) for all enrolled participants, participants will be split into 2 arms, randomly assigned to one of two interventions (Arms 2 or 3, CB-Abst or CB-Mon).

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: August 28, 2024
• Study Start: February 18, 2025
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): April 30, 2029
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Scientific data will be available one year after the grant end date specified on the first Notice of Award. Scientific data included in published manuscripts will be made available at the time of publication. Scientific data and the code/software/tools used to development the published or submitted dataset will be shared at the time of data submission or publication and maintained for no shorter than five years.
• Access Criteria: Data access will be controlled. In order to access shared data, qualified researchers will be required to complete a data use certification and receive approval from NDA Data Access Committee.

Locations

US (1)