Cannabis, Linked Emotions, and Adolescent Risk Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-18
SponsorMassachusetts General Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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);
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Contingency management for cannabis abstinence
BehavioralThose randomized to the abstinence condition (CB-Abst) will be incentivized using an escalating reinforcement schedule for eight weeks of cannabis abstinence.
Treatment groups
200 Participants
are divided into 3 treatment groupsGroup A: Cannabis Abstinence (CB-Abst)Experimental treatment 1 intervention
Group B: Cannabis Monitoring (CB-Mon)No intervention 0 interventions
Group C: Pre-intervention Pooled Groups (EMA Phase 1 Only)No intervention 0 interventions
Trial outcomes
Primary outcomes
1
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).
Time frame
Weeks 1 - 2 (EMA Phase 1; Baseline Use as Usual)2
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).
Time frame
Weeks 1 - 2 (EMA Phase 1; Baseline Use as Usual)3
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).
Time frame
Weeks 1 - 3, Week 10 (EMA Phase 2-3; Randomized Withdrawal then Sustained Abstinence)4
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).
Time frame
Weeks 1 - 3, Week 10 (EMA Phase 2-3; Randomized Withdrawal then Sustained Abstinence)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Massachusetts General Hospital
Lead sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov