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OpenTrials
Completed

NCT Number: NCT02511808

Adaptive Interventions for Problem Drinkers

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwell Health

Great Neck, New York, 11021, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Brief Advice

Behavioral

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

Behavioral

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

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.

Primary outcomes

  1. Time Line Follow Back

    Time frame: 24 Weeks

    Calendar-based method of recording drinking patterns. Data will be aggregated into summary variables.

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jul 30, 2015
Registry last updated
Sep 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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