Clinical trial NCT06576076: Cannabis, Linked Emotions, and Adolescent Risk Study
Official title: Characterizing Proximal Risk for Depressive Symptoms and Suicidal Ideation with Acute Cannabis Use and Withdrawal Among Adolescents Using Ecological Momentary Assessment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cannabis Use
Depression
Suicidal Ideation
Adolescent Behavior
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2024-08-28
Enrollment: 200
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility criteria: 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 or current depressive episode (Mini International Neuropsychiatric Interview Kid 7.0.2);
* 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 60% 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.

Primary outcomes:
measure: Aim 1: Cannabis use in the last hour
timeFrame: Weeks 1 - 2 (EMA Phase 1; Baseline Use as Usual)
measure: Aim 1: Motivation to use cannabis to improve mood collected
timeFrame: Weeks 1 - 2 (EMA Phase 1; Baseline Use as Usual)
measure: Aim 2: Depleted mood
timeFrame: Weeks 1 - 3, Week 10 (EMA Phase 2-3; Randomized Withdrawal then Sustained Abstinence)
measure: Aim 2: Negative cognitive impact
timeFrame: Weeks 1 - 3, Week 10 (EMA Phase 2-3; Randomized Withdrawal then Sustained Abstinence)
measure: Aim 2: Negative activation
timeFrame: Weeks 1 - 3, Week 10 (EMA Phase 2-3; Randomized Withdrawal then Sustained Abstinence)
measure: Aim 2: Passive suicidal ideation
timeFrame: Weeks 1 - 3, Week 10 (EMA Phase 2-3; Randomized Withdrawal then Sustained Abstinence)
measure: Aim 2: Suicidal urges
timeFrame: Weeks 1 - 3, Week 10 (EMA Phase 2-3; Randomized Withdrawal then Sustained Abstinence)
measure: Aim 2: Non-suicidal self-injury urges
timeFrame: Weeks 1 - 3, Week 10 (EMA Phase 2-3; Randomized Withdrawal then Sustained Abstinence)
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hopsital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Randi M Schuster, PhD
role: PRINCIPAL_INVESTIGATOR
References: