Clinical Trial

Amplification of Positivity for Alcohol Use

Study acronym: AMP-A
Recruiting
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Record status
This record was last updated July 18, 2025 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.
Summary
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).
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2023-09-06; most recent amendment 2025-07-15.
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 Alcohol Use Disorder, Anxiety, Depression
Enrollment 100 participants
Start Date 2023-09-25
Primary Completion 2026-07 (estimated)
Study Completion 2026-07 (estimated)
Updated on ClinicalTrials.gov 2025-07-18