Cannabis UseCLEARNCT06576076
Cannabis, Linked Emotions, and Adolescent Risk Study
A study testing Contingency management for cannabis abstinence in people with Cannabis Use and Depression, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Cannabis Use, Depression, Suicidal Ideation
- What is being tested?
- Contingency management for cannabis abstinence
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2025to 30 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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;
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hopsital
Boston, Massachusetts, 02114
Randi M Schuster, PhD, 617-643-6673, rschuster@mgh.harvard.edu
Julia Jashinski, MSW, 617-643-1984, jjashinski@mgh.harvard.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Cannabis Use, Depression, Suicidal Ideation, Adolescent Behavior
- Being tested
- Contingency management for cannabis abstinence
- Medical subject headings
- Depression, Suicidal Ideation, Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contingency management for cannabis abstinenceBehavioural
Those randomized to the abstinence condition (CB-Abst) will be incentivized using an escalating reinforcement schedule for eight weeks of cannabis abstinence.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Weeks 1 - 3, Week 10 (EMA Phase 2-3; Randomized Withdrawal then Sustained Abstinence)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start18 Feb 2025
- Primary completion30 Apr 2029 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cannabis UseStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Randi Melissa Schuster, Massachusetts General Hospital
- Investigators
- Randi M Schuster, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06576076
- Sponsor's protocol ID
- 2024P002417
- Other IDs
- 1R01DA054145-01A1
- Acronym
- CLEAR
- Status last verified
- Feb 2026
- First submitted
- 20 Aug 2024
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 41411314
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterizing Proximal Risk for Depressive Symptoms and Suicidal Ideation With Acute Cannabis Use and Withdrawal Among Adolescents Using Ecological Momentary Assessment
- ClinicalTrials.gov ID
- NCT06576076
- Acronym / sponsor ID
- CLEAR / 2024P002417
- Conditions
- Cannabis Use, Depression, Suicidal Ideation, Adolescent Behavior
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 18 Feb 2025 (actual)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 28 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Cannabis Abstinence (CB-Abst) | Experimental | Behavioral: Contingency management for cannabis abstinenceThose 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. |
| 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). |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contingency management for cannabis abstinenceThose randomized to the abstinence condition (CB-Abst) will be incentivized using an escalating reinforcement schedule for eight weeks of cannabis abstinence. | Behavioural | Cannabis Abstinence (CB-Abst) |
Primary outcome
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).
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).
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).
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).
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).
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).
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).
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Derived from this study: PubMed 41411314Feibus 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.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Cannabis Use
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
RecruitingPhase 1
Acute Effects of Cannabis on Cognition and Affect
Cannabis Use
RecruitingPhase 3
Efficacy of PP-01 in Mitigating Cannabis Withdrawal Symptoms in Adults With Cannabis Use Disorder
Cannabis Withdrawal
Active, not recruitingObservational study
Cannabis Use and Outcomes in Black and White Patients With Cancer
Cancer
RecruitingObservational study
A Study in Patients Reporting Cannabis Use Followed With an Application-Based Cannabis Journal
Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Randi M Schuster, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contingency management for cannabis abstinence in people with Cannabis Use and Depression, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Randi M Schuster, PhD (617-643-6673, rschuster@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aim 1: Cannabis use in the last hour (time frame: Weeks 1 - 2 (EMA Phase 1; Baseline Use as Usual)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06576076, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.