Cannabis, Linked Emotions, and Adolescent Risk Study (CLEAR)

February 27, 2026 updated by: Randi Melissa Schuster, Massachusetts General Hospital

Characterizing Proximal Risk for Depressive Symptoms and Suicidal Ideation With Acute Cannabis Use and Withdrawal Among Adolescents Using Ecological Momentary Assessment

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

We will recruit 200 community-based adolescents, ages 12-18 years, with daily or near daily cannabis use and current depression symptoms. Participants will be enrolled in a 10-week, 3-phased, mixed-methods protocol. All participants will complete a 2 week baseline phase (Phase 1) involving real-time, ambulatory smartphone monitoring (ecological momentary assessment; EMA) during which they will use cannabis per usual to quantify the temporal relationship between use and mood and SI, and the within- (e.g., concurrent other substance use, social context of use) and between-subject factors (e.g., severity of cannabis use, depression and SI) that moderate these linkages. We will work with participants schedule to ensure that the start of this 2-week baseline phase coincides with when they do not anticipate any major deviations from their typical pattern of cannabis use (e.g., family vacation, exam week). After the baseline phase, participants will be scheduled for the randomization component of the study, which will employ a 2-arm, within-subject, parallel group design to examine the effects of short- and longer-term cannabis withdrawal across 8 weeks of cannabis abstinence on depression and SI. Participants will be randomized to 8 weeks of abstinence with contingency management (CB-Abst; n=100) or non-contingent monitoring with no abstinence requirement (CBMon; n=100). Randomization will occur in a 1:1 ratio in blocks of 6 based on a computerized scheme developed by the study statistician. Randomization will be stratified by age, sex, and depression severity. A key aspect of the approach is that the 8-week period is long enough to observe true changes due to cannabis discontinuation, separate from effects of cannabis withdrawal, and residual cannabinoid exposure. Both groups will complete 1-week of EMA in weeks 1 (Phase 2) and 8 (Phase 3) of the randomized study period. In addition to the 3 waves of smartphone, EMA data collection, participants will complete 12 study visits across ~10 weeks. Visits will entail collection of urine samples for verification of self-reported use and abstinence verification (for CB-Abst during the randomization phase), as well as brief questionnaires and interviews on interim substance use, craving, withdrawal, mood symptoms, and SI.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: 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.
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Aim 1: Cannabis use in the last hour
Time Frame: Weeks 1 - 2 (EMA Phase 1; Baseline Use as Usual)
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
Time Frame: Weeks 1 - 2 (EMA Phase 1; Baseline Use as Usual)
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
Time Frame: Weeks 1 - 3, Week 10 (EMA Phase 2-3; Randomized Withdrawal then Sustained Abstinence)
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
Time Frame: Weeks 1 - 3, Week 10 (EMA Phase 2-3; Randomized Withdrawal then Sustained Abstinence)
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
Time Frame: Weeks 1 - 3, Week 10 (EMA Phase 2-3; Randomized Withdrawal then Sustained Abstinence)
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
Time Frame: Weeks 1 - 3, Week 10 (EMA Phase 2-3; Randomized Withdrawal then Sustained Abstinence)
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
Time Frame: Weeks 1 - 3, Week 10 (EMA Phase 2-3; Randomized Withdrawal then Sustained Abstinence)
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
Time Frame: Weeks 1 - 3, Week 10 (EMA Phase 2-3; Randomized Withdrawal then Sustained Abstinence)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Massachusetts General Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Randi M Schuster, PhD, Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 18, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 20, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 28, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024P002417
  • 1R01DA054145-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

As outlined in the approved Data Management and Sharing Plan, IPD will be deposited in the NIMH Data Archive. This is a free data repository open to qualified researchers from all mental health and other research communities to share, archive, cite, access, and explore research data. Clinical data necessary to validate and replicate research findings, including questionnaires, interviews, ecological momentary assessment data, urine drug test results, and Fitbit recordings, will be shared.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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