Remote Alcohol Monitoring to Facilitate Abstinence From Alcohol: Exp 1

Mikhail N Koffarnus

Status: Active, not recruiting

Conditions: Alcohol Use Disorder

Treatments: Behavioral: Contingency management

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03883126

R01AA026605

54073

Details and patient eligibility

About

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 study is to use technological advancements to remotely, accurately, and securely monitor alcohol use with a newly developed smartphone app and breathalyzer. 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.

Enrollment: 211 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Meet Diagnostic and Statistical Manual (DSM)-5 criteria for alcohol use disorder
• Average 3 or more heavy drinking days (≥5 drinks in one occasion for men, ≥4 for women) per week for the past month on the Timeline Follow-back.
• Must endorse alcohol as their primary drug of use.
• Express a desire to abstain from drinking.

Exclusion criteria

• Are currently enrolled in an alcohol treatment program (not including attendance at Alcoholics Anonymous or similar community support meetings).
• Score 23 or greater on the Alcohol Withdrawal Symptom Checklist, a score indicating that medication would be likely required to manage alcohol detoxification.
• Pregnant women, lactating women, or women who are planning to become pregnant in the next 15 months.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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211 participants in 5 patient groups

Group A

Active Comparator group

Description:

Group A 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 for the first 3 weeks of the intervention. For the remaining 9 weeks they will continue to receive incentives for submitting negative samples.

Treatment:

Behavioral: Contingency management

Behavioral: Contingency management

Group B

Active Comparator group

Description:

Group B 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 for the first 3 weeks of the intervention.For the remaining 9 weeks they will not be required to submit breathalyzer samples.

Treatment:

Behavioral: Contingency management

Behavioral: Contingency management

Group C

Sham Comparator group

Description:

Group C will receive nearly immediate monetary payments over the internet each day they remotely provide breathalyzer samples regardless of the alcohol content, but will not receive the payments if they fail to provide samples in a timely manner for the first 3 weeks of the intervention. For the remaining 9 weeks they will continue to receive incentives for submitting on time samples regardless of alcohol content.

Treatment:

Behavioral: Contingency management

Behavioral: Contingency management

Group D

Sham Comparator group

Description:

Group D will receive nearly immediate monetary payments over the internet each day they remotely provide breathalyzer samples regardless of the alcohol content, but will not receive the payments if they fail to provide samples in a timely manner for the first 3 weeks of the intervention. For the remaining 9 weeks they will not be required to submit breathalyzer samples.

Treatment:

Behavioral: Contingency management

Behavioral: Contingency management

Group E

No Intervention group

Description:

Group E will have no intervention, they will only complete assessment sessions.