Amplification of Positivity for Alcohol Use

Study acronym: AMP-A
StatusActive, Not Recruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 5 months later Jul 2026 → Jan 2027
See other at-risk trials from Laureate Institute for Brain Research, Inc.

Record History

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  1. Enrollment closed, study ongoing Show 6 more changesShow less
    • Primary completion pushed from Jul 2026 to Jan 2027
    • Study completion pushed from Jul 2026 to Apr 2027
    • Eligibility criteria expanded, about 21 words
    • Secondary endpoints: details revised at 7 of 7 entries
    • Site details revised
    • Publications: details revised at 3 of 3 entries
  2. Eligibility criteria expanded, about 135 wordsv3
  3. Start date changed from estimate of Sep 2023 to Sep 25, 2023v2
  4. Study First Submitted
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The proposed study consists of two phases. During Phase 1, the investigators will recruit a small sample of participants to complete a psychosocial intervention termed Amplification of Positivity (AMP) for individuals experiencing comorbid depression or anxiety disorders and alcohol use disorder (AMP-A). These participants will be asked to provide both qualitative and quantitative input about the AMP-A intervention. Based on their input and clinician input, the AMP-A manual will be modified for use in Phase 2. The goal is to recruit up to 20 participants in order to ensure there will be at least 8 participants who complete all sessions of AMP-A. Phase 2 is a randomized clinical trial (RCT) protocol in which individuals experiencing comorbid depression or anxiety disorders and alcohol use disorder will be randomized to complete AMP-A or an evidence-based cognitive-behavioral therapy (CBT) intervention. Up to 100 participants will be recruited in order to reach a target of N=60. Assessed outcomes will include participant acceptability and completion rates, participant compliance with the intervention, positive and negative affect, substance use- and depression and anxiety-related symptom severity, functional disability, and neural reactivity to reward and alcohol cues during functional magnetic resonance imaging (fMRI).
Trial Details
NCT Number NCT06030154
Lead Sponsor Laureate Institute for Brain Research, Inc.
Collaborators: University of California, San Diego, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions
(from sponsor)		 Alcohol Use Disorder, Anxiety, Depression
Related terms Alcoholism, Anxiety Disorders, Depression
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov