Remote Alcohol Monitoring to Facilitate Abstinence Reinforcement: Feasibility
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|ClinicalTrials.gov Identifier: NCT03507075|
Recruitment Status : Completed
First Posted : April 24, 2018
Last Update Posted : April 24, 2018
Information provided by (Responsible Party):
Mikhail Koffarnus, Virginia Polytechnic Institute and State University
Directly reinforcing abstinence from alcohol with monetary incentives is an effective treatment for alcohol dependence, but barriers in obtaining frequent, verified biochemical measures of abstinence limit the dissemination of this treatment approach. The goal of this feasibility study is to determine if using technological advancements to remotely, accurately, and securely monitor alcohol use with a newly developed breathalyzer is an effective treatment that is acceptable to participants. If validated, this treatment approach has the potential to facilitate the dissemination of an effective, evidence-based treatment for alcohol dependence to a broader population whose treatment needs are not currently being adequately met.
|Condition or disease||Intervention/treatment||Phase|
|Alcohol Use Disorder||Behavioral: Contingency management: Contingent incentives Behavioral: Contingency management: Noncontingent incentives||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||69 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Remote Alcohol Monitoring to Facilitate Abstinence Reinforcement: Feasibility|
|Actual Study Start Date :||November 15, 2014|
|Actual Primary Completion Date :||January 5, 2017|
|Actual Study Completion Date :||January 5, 2017|
Active Comparator: Contingent
The Contingent group will receive nearly immediate monetary payments over the internet each day they remotely provide negative breathalyzer samples, but will not receive the payments if they provide positive samples or fail to provide samples in a timely manner.
Behavioral: Contingency management: Contingent incentives
Monetary incentives are delivered to participants contingent upon on-time breathalyzer submissions and verified abstinence from alcohol.
Sham Comparator: Noncontingent
The Noncontingent group will receive payments each day they successfully provide samples independent of the alcohol content of those samples.
Behavioral: Contingency management: Noncontingent incentives
Monetary incentives are delivered to participants contingent upon on-time breathalyzer submissions only with no contingency on alcohol use.
Primary Outcome Measures :
- Percent days abstinent from alcohol during intervention [ Time Frame: Percent days abstinent is the aggregate measure throughout the 21-day intervention period ]Three breathalyzer assessments will be collected per day during the treatment period. This outcome measure will consist of the percent days when all three breathalyzers were on time and negative for alcohol.
- Treatment acceptability [ Time Frame: Baseline, one day after treatment end, and at a one-month follow-up ]Participant ratings of treatment acceptability will be collected during assessment sessions
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