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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.
Awards & highlights
Study 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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
801 Previous Clinical Trials
1,365,197 Total Patients Enrolled
423 Trials studying Alcoholism
985,508 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
Media Library
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are being accepted into this research trial?
"Affirmative. Clinicaltrials.gov details demonstrate that this research investigation is still actively searching for applicants, having been initially posted on June 16th 2020 and lastly edited October 13th 2022. A total of 200 subjects must be enrolled from two separate clinical trial sites."
Answered by AI
Is this clinical study currently accepting participants?
"Affirmative. The information located on clinicaltrials.gov attests that this medical trial is actively recruiting participants, which was first posted to the website in June of 2020 and was last updated in October 2022. 200 patients are needed between two locations for successful completion of the study."
Answered by AI
Who else is applying?
What site did they apply to?
Nationwide Online Enrollment from the Unversity of Kentucky
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
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