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Remote Alcohol Monitoring to Facilitate Abstinence From Alcohol: Exp 2

M

Mikhail N Koffarnus

Status

Active, not recruiting

Conditions

Alcohol Use Disorder

Treatments

Behavioral: Contingency Management
Behavioral: Contingency management

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT03942770
19-324
R01AA026605

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. As our feasibility study demonstrates, remote breathalyzer monitoring drastically improves the practicality of delivering an alcohol contingency management intervention. In Experiment 2, we will test whether the addition of remote abstinence incentives to treatment as usual improves outpatient treatment outcomes and prevents relapse following inpatient detoxification at a regional hospital system. We will also assess whether readmission rates are reduced using a newly developed smartphone app and breathalyzer.

Enrollment

91 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Recently completed or currently completing an alcohol detoxification program through the Carilion Clinic or University of Kentucky Healthcare system.
  • Meet DSM-V criteria for alcohol use disorder.
  • Abstinent from alcohol at the time of consent.

Exclusion criteria

  • Alcohol use disorder is secondary to another substance use disorder.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

91 participants in 5 patient groups

Active Comparator: Group A (Intensive incentives)
Active Comparator group
Description:
Group A will have the opportunity to earn payments based on the results of their breathalyzer screens. Participants will receive a compliance incentive per submitted sample regardless of the results, but will also have the opportunity to earn more incentives for providing negative results. For the first 3 weeks, these additional incentives will scale based on the number of consecutive days of sustained negative samples. For the remaining weeks incentives will be based on a randomized "prize" drawing.
Treatment:
Behavioral: Contingency Management
Active Comparator: Group B (Prize-based incentives)
Active Comparator group
Description:
Group B will have the opportunity to earn payments based on the results of their breathalyzer screens. Participants will receive a compliance incentive per submitted sample regardless of the results, but will only have the opportunity to earn more incentives based on a randomized "prize" drawing if they submit a negative sample.
Treatment:
Behavioral: Contingency Management
Sham Comparator: Group C (Intensive incentives)
Sham Comparator group
Description:
Group C serves as a direct control group to Group A and will follow the same incentive procedures, however participants will receive incentives regardless of the results of their samples.
Treatment:
Behavioral: Contingency management
Sham Comparator: Group D (Price-based incentives)
Sham Comparator group
Description:
Group D serves as a direct control group to Group B and will follow the same incentive procedures, however participants will receive incentives regardless of the results of their samples.
Treatment:
Behavioral: Contingency management
No Intervention: Group E (no incentives)
No Intervention group
Description:
Group E will have no monitoring intervention, they will only complete assessment sessions.

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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