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NCT06395467 · ClinicalTrials.gov registry record · NA
Integrated Treatment for Enhancing Growth in Recovery During Adolescence
A NA study of Alcohol Use Disorder and Cannabis Use Disorder, sponsored by Massachusetts General Hospital.
- Recruiting
- Registry status
- NA
- Development phase
- 294
- Enrollment target
- 2
- Study locations
NCT06395467: Recruiting NA study of Alcohol Use Disorder and Cannabis Use Disorder, sponsored by Massachusetts General Hospital.
NCT06395467 is a NA study of Alcohol Use Disorder and Cannabis Use Disorder that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 294 participants, below the 327-participant average among 184 other Alcohol Use Disorder trials with a reported enrollment target (10% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06395467, a NA study of Alcohol Use Disorder and Cannabis Use Disorder, is actively recruiting participants, sponsored by Massachusetts General Hospital.
- RECRUITING
- Registry status
- NA
- Development phase
- 294 participants
- Enrollment target
- 2
- Study locations
Study Summary
This is a Phase II parallel group randomized controlled trial with 294 adolescents (age: 14-21 years) with alcohol and other drug \[AOD\] use disorder (hereafter substance use disorder), that compares two different active psychosocial interventions designed to address adolescent substance use disorder. Participants are recruited from our clinical settings and the community at two sites: one in the metro Boston, Massachusetts (MA) area and the other in the metro Farmington, Connecticut (CT), area. Study aims and hypotheses are as follows: 1. To extend the evidence for the initial efficacy of Integrated Treatment for Enhancing Growth in Recovery During Adolescence (InTEGRA), which integrates 12-Step Facilitation (TSF) with Motivational Enhancement Therapy/Cognitive Behavioral Therapy (MET/CBT) relative to gold standard MET/CBT alone (N = 294). It is hypothesized that youth assigned to InTEGRA will have greater 12-step participation during and following treatment, higher abstinence rates, and fewer substance-related negative consequences. 2. Investigate the personal recovery capital (PRC) and social recovery capital (SRC) mechanisms of behavior change through which InTEGRA may confer benefits dynamically over time (e.g., PRC: motivation, self-efficacy, coping; SRC: 12-step involvement; social network changes). 3. Investigate moderators of InTEGRA's effects on outcomes across one-year follow-up (e.g., effect of age, network support for AOD use; psychiatric severity; age composition of 12-step meetings on substance use and substance-related consequences). It is hypothesized that higher network support for AOD use, abstinence motivation, and greater AOD severity, will have a better response to InTEGRA. 4. Explore barriers and facilitators to InTEGRA adoption and implementation across providers and system administrators within the context of a type I hybrid effectiveness-implementation research design.
Primary Outcome
Percent Days Abstinent (PDA) from alcohol and other drugs (cannabis, opioids, etc.). Derived from Timeline Followback (TLFB) and Form-90 measures of substance use. Abstinence reports confirmed with Breathalyzer and Toxicology Screen data.
Conditions Studied
Interventions
- BEHAVIORAL InTEGRA
- BEHAVIORAL MET/CBT
Study Locations (2)
Connecticut
- UConn Health - Farmington
Massachusetts
- MGH Department of Psychiatry - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 294 participants |
| Start Date | 2024-11-26 |
| Est. Completion | 2028-05-31 |
| Phase | NA |
What NCT06395467 shows while recruiting
NCT06395467 is an interventional study that assigns participants to a tested intervention. The registered 294 participants enrollment target is mid-sized for trials with a published cap, below the 327-participant average among 184 other Alcohol Use Disorder trials with a reported enrollment target (10% lower).
The record links to 2 conditions, with Alcohol Use Disorder appearing as the primary indexed condition, and to 2 interventions - of which InTEGRA is the first listed.
NCT06395467 reports a single indexed study location in Connecticut, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06395467 about?
NCT06395467 is a clinical study titled "Integrated Treatment for Enhancing Growth in Recovery During Adolescence". This is a Phase II parallel group randomized controlled trial with 294 adolescents (age: 14-21 years) with alcohol and other drug \[AOD\] use disorder (hereafter substance use disorder), that compares two different active psychosocial interventions designed to address adolescent substance use disord...
What is the current status of trial NCT06395467?
This trial is currently recruiting. It is a NA study. The enrollment target is 294 participants. The study started on 2024-11-26. Estimated completion is 2028-05-31.
What conditions does trial NCT06395467 study?
This clinical trial studies the following conditions: Alcohol Use Disorder, Cannabis Use Disorder.
What interventions are being tested in trial NCT06395467?
The interventions under investigation include: InTEGRA (BEHAVIORAL), MET/CBT (BEHAVIORAL).
Who is sponsoring clinical trial NCT06395467?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06395467 being conducted?
This trial has 2 study locations across Connecticut, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Alcohol Use Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06395467's enrollment target sits among peer trials
294 31st of 184 higher than 154 of 184 other Alcohol Use Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alcohol Use Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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