Status:
RECRUITING
Cannabis, Linked Emotions, and Adolescent Risk Study
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Cannabis Use
Depression
Eligibility:
All Genders
12-18 years
Phase:
NA
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 t...
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-me...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 18 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06576076
Start Date
February 18 2025
End Date
December 31 2028
Last Update
November 7 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Massachusetts General Hopsital
Boston, Massachusetts, United States, 02114