Adaptive Interventions for Problem Drinkers

Alcoholism Clinical Trial

Official title:

Adaptive Interventions for Problem Drinkers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02511808
• Other study ID #: 14-413
• Secondary ID: R01AA022714
• Status: Completed
• Phase: N/A
• Start date: March 2015
• Est. completion date: May 2019

Study information

• Verified date: September 2020
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to understand how certain interventions help people reduce or quit their drinking and how certain interventions may help best at certain points in time in the change process.

Description:

Problem drinkers (PDs) represent a majority of the estimated 32 million Americans with alcohol problems that spans a spectrum of severity from individuals who drink excessively and experience of occasional negative consequences to those with moderate Alcohol Dependence (AD) and intact psychosocial functioning. PDs can benefit from relatively brief treatment that could be delivered in mainstream healthcare, but less than 5% receive such care. In addition, PD treatment is only modestly effective, and there is a surprising absence of empirical research to guide PD treatment selection. Adaptive Interventions (AI) are a novel approach to treatment development that may have significant advantages over fixed treatments in improving efficacy and fostering adoption of Evidence Based Practices in mainstream healthcare. If study aims are achieved, a set of empirically-derived decision support tools will be created to guide Alcohol Use Disorders (AUD) care similar to tools that exist for other chronic diseases. In addition, new knowledge will be gained about Mechanisms of Behavior Change of AUD that can guide future AUD treatment research. Finally, important progress will be made in methods that capitalize on the remarkable advances in sensor technologies, advanced mathematics, and engineering to create a new type of tailored, near-real time feedback, adaptive behavior therapies.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: May 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Primary Inclusion Criteria: Adults who have heavy weekly alcohol consumption (and/or an alcohol use disorder) and are willing to reduce their drinking.

Primary Exclusion Criteria: Adults for whom the level of treatment provided is not appropriate and/or who require more intensive substance use or psychiatric treatment.

Related Conditions & MeSH terms

• Alcohol Abuse
• Alcohol Drinking
• Alcohol Use Disorders
• Alcohol-Related Disorders
• Alcoholism
• Disease

Intervention

Behavioral:
• Brief Advice
Brief Advice (BA) consists of a 20-minute session delivered by a study therapist, adhering to the NIAAA's Clinician Guide to Problem Drinkers. It includes personalized, normative feedback based on NIAAA drinking norms, goal selection, instructions on self-monitoring, discussion of drink reduction strategies, and distribution of the NIAAA bibliotherapy guide.
• Motivational Interviewing
Motivational Interviewing will consist of standard techniques, such as developing discrepancy, enhancing motivation, and developing a change plan, that have been adapted to treatment for problem drinkers.
• Behavioral Self-Control Training
Behavioral Self-Control Training will consist of Cognitive Behavioral Therapy adapted to problem drinkers, whose core components include a functional analysis, skills training, daily self-monitoring, homework, and graded exposures and mastery of high risk situations.

Locations

Country	Name	City	State
United States	Northwell Health	Great Neck	New York

Sponsors (2)

Lead Sponsor	Collaborator
Northwell Health	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Kuerbis AN, Shao S, Treloar Padovano H, Jadanova A, Selva Kumar D, Vitale R, Nitzburg G, Vadhan NP, Morgenstern J. Context and craving among individuals with alcohol use disorder attempting to moderate their drinking. Exp Clin Psychopharmacol. 2020 Jan 23. doi: 10.1037/pha0000349. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time Line Follow Back	Calendar-based method of recording drinking patterns. Data will be aggregated into summary variables.	24 Weeks