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Unified Protocol for Alcoholism

N/A
Recruiting
Led By Todd Farchione, PhD
Research Sponsored by Boston University Charles River Campus
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
DSM-5 diagnosis of an alcohol use disorder (AUD)
Expressed desire to stop drinking alcohol completely or to reduce alcohol consumption
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline following 16-week treatment
Awards & highlights

Study Summary

This trial will help to assess whether the Unified Protocol, a cognitive-behavioral therapy, is more effective than a computerized alcohol reduction program in reducing alcohol consumption in patients with comorbid alcohol use disorders and anxiety disorders.

Eligible Conditions
  • Alcoholism
  • Anxiety Disorders

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have been diagnosed with a problem with alcohol by a doctor using a manual called DSM-5.
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You want to either completely stop drinking alcohol or reduce how much you drink.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline following 16-week treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline following 16-week treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean Number of Drinks Consumed Per Day

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Unified ProtocolActive Control1 Intervention
The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) consists of 5 core skills modules based on cognitive behavioral treatment elements of proven effectiveness. As noted above, these core skills modules were designed to target (and have been shown to address) negative emotionality and aversive reactivity to emotional experiences when they occur (Boswell et al., 2013; Carl et al., 2014; Sauer-Zavala et al., 2012). These modules are preceded by an introductory session that reviews the patient's presenting symptoms and provides a therapeutic rationale, as well as a module on motivational enhancement. A final module consists of relapse prevention. As the treatment proceeds, the domains of thoughts, feelings, and behaviors are each explored in detail, focusing specifically on elucidating dysfunctional emotion regulation strategies that the patient has developed over time within each of these domains, and teaching patients more adaptive emotion regulation skills.
Group II: Take ControlPlacebo Group1 Intervention
TC is a psychotherapy platform derived from the National Institute on Alcohol Abuse and Alcoholism's (NIAAA) self-help approach, Rethinking Drinking. In this study, TC, originally designed as a computerized treatment has been modified to be administered by the therapist to control for effects that may be related to patient-therapist interaction (as opposed to elements of the treatment itself). Specifically, on a weekly basis, therapists will review material from TC and offer general advice on implementation of the alcohol reduction skills in daily life.

Find a Location

Who is running the clinical trial?

Boston University Charles River CampusLead Sponsor
113 Previous Clinical Trials
12,101 Total Patients Enrolled
2 Trials studying Alcoholism
301 Patients Enrolled for Alcoholism
Todd Farchione, PhD5.01 ReviewsPrincipal Investigator - Boston Univeristy
Boston University Charles River Campus

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~9 spots leftby Mar 2025