Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06576076
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-20
Brief Title:
Assessment of Cannabis Use and Depression in Everyday Moments Among Youth ACADEMY
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Characterizing Proximal Risk for Depressive Symptoms and Suicidal Ideation With Acute Cannabis Use and Withdrawal Among Adolescents Using Ecological Momentary Assessment
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 current depression and past month SI 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- eg concurrent other substance use social context of use and between-subject factors eg 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 eg 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 n100 or non-contingent monitoring with no abstinence requirement CBMon n100 Randomization will occur in a 11 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None