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Behavioral Intervention
Monetary Incentives for Abstinence in Alcoholism
N/A
Waitlist Available
Research Sponsored by Mikhail N Koffarnus
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up a total of 12 assessment sessions spanning over a 66 week period
Summary
This trial will test whether adding monetary incentives for abstinence to standard treatment improves outcomes for people with alcohol dependence.
Who is the study for?
This trial is for individuals who are currently not drinking alcohol and have recently finished or are finishing an alcohol detox program at Carilion Clinic or University of Kentucky Healthcare. Participants must meet the criteria for alcohol use disorder as per DSM-V but cannot have a primary substance use disorder other than alcohol.
What is being tested?
The study tests if adding monetary incentives for staying sober, verified through a remote breathalyzer connected to a smartphone app, can improve treatment outcomes and reduce relapse after inpatient detox compared to usual outpatient treatments.
What are the potential side effects?
Since this trial involves behavioral interventions with no medications involved, there are no direct medical side effects. However, participants may experience stress or anxiety related to maintaining abstinence to receive monetary rewards.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ a total of 12 assessment sessions spanning over a 66 week period
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~a total of 12 assessment sessions spanning over a 66 week period
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Pattern of abstinence from alcohol during intervention
Time to relapse
Treatment acceptability
Trial Design
5Treatment groups
Active Control
Placebo Group
Group I: Active Comparator: Group A (Intensive incentives)Active Control1 Intervention
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.
Group II: No Intervention: Group E (no incentives)Active Control1 Intervention
Group E will have no monitoring intervention, they will only complete assessment sessions.
Group III: Active Comparator: Group B (Prize-based incentives)Active Control1 Intervention
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.
Group IV: Sham Comparator: Group C (Intensive incentives)Placebo Group1 Intervention
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.
Group V: Sham Comparator: Group D (Price-based incentives)Placebo Group1 Intervention
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.
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Who is running the clinical trial?
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
835 Previous Clinical Trials
1,082,540 Total Patients Enrolled
456 Trials studying Alcoholism
823,556 Patients Enrolled for Alcoholism
Mikhail N KoffarnusLead Sponsor
2 Previous Clinical Trials
673 Total Patients Enrolled
1 Trials studying Alcoholism
200 Patients Enrolled for Alcoholism
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your alcohol addiction is caused by your addiction to another substance.You have a problem with alcohol use that meets the standard criteria set by the DSM-V.You have not consumed alcohol before signing up for the study.
Research Study Groups:
This trial has the following groups:- Group 1: Active Comparator: Group A (Intensive incentives)
- Group 2: No Intervention: Group E (no incentives)
- Group 3: Active Comparator: Group B (Prize-based incentives)
- Group 4: Sham Comparator: Group C (Intensive incentives)
- Group 5: Sham Comparator: Group D (Price-based incentives)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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