Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT06030154

Amplification of Positivity for Alcohol Use

Led by Laureate Institute for Brain Research, Inc. · Updated on 2025-07-18

100

Participants Needed

1

Research Sites

144 weeks

Total Duration

On this page

Sponsors

L

Laureate Institute for Brain Research, Inc.

Lead Sponsor

U

University of California, San Diego

Collaborating Sponsor

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

Amplification of Positivity for Alcohol Use

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 65 years old
  • Diagnosis of alcohol use disorder according to DSM-5
  • Desire to seek treatment for alcohol use disorder as a primary concern
  • Significant depression or anxiety symptoms as measured by PHQ-9 ≥ 10 and/or OASIS ≥ 8 (Phase 1) or NIH PROMIS Depression/Anxiety score ≥ 55 (Phase 2)
  • Below normal levels of positive affect (PROMIS Positive Affect < 50)
  • Ability to provide written informed consent
  • Sufficient English proficiency to complete study procedures
Not Eligible

You will not qualify if you...

  • Unwillingness or inability to complete major parts of the study protocol
  • Vision or hearing problems interfering with assessments
  • No telephone or easy telephone access
  • Diagnosis of schizophrenia spectrum, other psychotic disorders, OCD, eating disorders, recent substance use disorders except alcohol or cannabis, or bipolar I disorder
  • Active suicidal thoughts with plan and intent within the next month
  • History of unstable liver or kidney problems, glaucoma, serious cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, or metabolic conditions
  • Positive drug or alcohol test at baseline (excluding physician-prescribed medications)
  • Use of medications affecting brain function or positive valence system within 6 weeks prior to enrollment, except stable doses of antidepressants, benzodiazepines, or psychostimulants
  • Use of drugs affecting fMRI response (Phase 2 only)
  • Recent start of psychosocial treatments targeting alcohol use or mood symptoms within 12 weeks
  • MRI contraindications for Phase 2 participants opting for imaging
  • Moderate to severe traumatic brain injury or other neurological disorders
  • Severe alcohol use disorder requiring intensive treatment
  • Special vulnerable populations such as pregnant women, fetuses, neonates, prisoners, or children

AI-Screening

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Trial Site Locations

Total: 1 location

1

Laureate Institute for Brain Research

Tulsa, Oklahoma, United States, 74008

Actively Recruiting

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Research Team

R

Robin L Aupperle, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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