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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 use a smartphone app and breathalyzer to remotely monitor alcohol abstinence in order to help people with alcohol dependence.
Who is the study for?
This trial is for adults who drink heavily at least three times a week and want to stop drinking. They must have an alcohol use disorder with alcohol as their main substance of abuse, but not be in another treatment program or need medication for detox.
What is being tested?
The study tests if using a smartphone app and breathalyzer can help people stay away from alcohol by giving them money rewards for staying sober. This could make it easier to treat more people with alcohol dependence effectively.
What are the potential side effects?
Since the intervention involves behavioral incentives rather than medication, there are no direct physical side effects expected from participating in this trial.
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
Treatment acceptability
Trial Design
5Treatment groups
Active Control
Placebo Group
Group I: Group BActive Control1 Intervention
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.
Group II: Group EActive Control1 Intervention
Group E will have no intervention, they will only complete assessment sessions.
Group III: Group AActive Control1 Intervention
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.
Group IV: Group DPlacebo Group1 Intervention
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.
Group V: Group CPlacebo Group1 Intervention
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.
Find a Location
Who is running the clinical trial?
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
835 Previous Clinical Trials
1,082,570 Total Patients Enrolled
456 Trials studying Alcoholism
823,586 Patients Enrolled for Alcoholism
Mikhail N KoffarnusLead Sponsor
2 Previous Clinical Trials
703 Total Patients Enrolled
1 Trials studying Alcoholism
230 Patients Enrolled for Alcoholism
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I want to stop drinking alcohol.You must consider alcohol as your main drug of choice.You have an alcohol addiction according to the DSM-5 criteria.
Research Study Groups:
This trial has the following groups:- Group 1: Group D
- Group 2: Group B
- Group 3: Group E
- Group 4: Group C
- Group 5: Group A
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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