Remote Monitoring for Alcoholism
Recruiting in Palo Alto (17 mi)
+4 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Mikhail N Koffarnus
Disqualifiers: Alcohol treatment program, Pregnancy, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Contingency Management for alcoholism?
Research shows that Contingency Management (CM), which uses rewards to encourage positive behavior like staying sober, is effective for treating substance use disorders, including alcohol. Studies have found that CM can be successfully delivered remotely, making it easier for people to access this treatment.12345
Is remote monitoring for alcoholism using contingency management safe for humans?
How is the treatment Contingency Management unique for alcoholism?
Research Team
Eligibility Criteria
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.Inclusion 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.
See 1 more
Exclusion Criteria
Pregnant women, lactating women, or women who are planning to become pregnant in the next 15 months.
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.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive monetary incentives for providing breathalyzer samples over a 12-week period, with different conditions for each group.
12 weeks
Remote monitoring with daily submissions
Follow-up
Participants are monitored for safety and effectiveness after treatment
54 weeks
12 assessment sessions
Treatment Details
Interventions
- Contingency management (Behavioral Intervention)
Trial OverviewThe 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.
Participant Groups
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 Clinic Near You
Research Locations NearbySelect from list below to view details:
Carilion ClinicRoanoke, VA
University of Kentucky TurflandLexington, KY
University of Kentucky Turfland: In-person enrollmentLexington, KY
Carilion Clinic: In person-enrollmentRoanoke, VA
More Trial Locations
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Who Is Running the Clinical Trial?
Mikhail N Koffarnus
Lead Sponsor
Trials
3
Patients Recruited
900+
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
Trials
865
Patients Recruited
1,091,000+
Findings from Research
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
A randomized study of cellphone technology to reinforce alcohol abstinence in the natural environment.Alessi, SM., Petry, NM.[2022]
The cost to set up a contingency management (CM) program for treating patients with severe alcohol use disorder and serious mental illness is approximately $6,038 per site, with average treatment costs ranging from $1,119 to $1,865 per participant over 16 weeks depending on the CM version used.
This study provides a customizable costing tool that helps treatment providers estimate expenses associated with different CM designs, which can aid in budgeting and sustaining CM interventions in their practices.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Budget Impact Tool for Implementing Contingency Management for Co-occurring Alcohol Use Disorders and Serious Mental Illness.Lu, TT., Parent, SC., Chaytor, N., et al.[2023]
Mobile telephone-delivered contingency management (CM) interventions significantly improve abstinence rates from tobacco and alcohol compared to control conditions, based on a systematic review of seven studies involving 222 participants.
The meta-analysis showed strong effect sizes for various outcomes, including a 94% increase in the percentage of negative samples and a 108% increase in the longest duration of abstinence, indicating that this low-cost approach can effectively support individuals with substance use disorders.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Mobile telephone-delivered contingency management interventions promoting behaviour change in individuals with substance use disorders: a meta-analysis.Getty, CA., Morande, A., Lynskey, M., et al.[2021]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
A systematic review of remotely delivered contingency management treatment for substance use.Coughlin, LN., Salino, S., Jennings, C., et al.[2023]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Contingency management: utility in the treatment of drug abuse disorders.Stitzer, ML., Vandrey, R.[2019]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Nationwide access to an internet-based contingency management intervention to promote smoking cessation: a randomized controlled trial.Dallery, J., Raiff, BR., Kim, SJ., et al.[2022]
A study involving 13 heavy drinking adults demonstrated that contingency management (CM) effectively reduced alcohol use, as evidenced by significant declines in both self-reported abstinence and transdermal alcohol measurements over three weeks.
The use of transdermal alcohol sensors, like the SCRAM bracelet, allowed for continuous monitoring and rapid reinforcement of abstinence, highlighting its feasibility for clinical applications in treating alcohol dependence.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Contingency management for alcohol use reduction: a pilot study using a transdermal alcohol sensor.Barnett, NP., Tidey, J., Murphy, JG., et al.[2022]
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Automated Reinforcement Management System: Feasibility study findings of an app-based contingency management treatment for alcohol use disorder.Miguel, AQ., Smith, CL., Rodin, NM., et al.[2023]
Contingency management is highly effective for promoting drug abstinence, and new technologies now allow for remote confirmation of abstinence and delivery of incentives, increasing accessibility to treatment.
These technology-based tools can assess substance use and facilitate group contingencies through online communities, potentially enhancing treatment fidelity and targeting multiple health-risk behaviors simultaneously.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Technology-Based Contingency Management in the Treatment of Substance-Use Disorders.Dallery, J., Raiff, BR., Grabinski, MJ., et al.[2023]
References
A randomized study of cellphone technology to reinforce alcohol abstinence in the natural environment. [2022]
Budget Impact Tool for Implementing Contingency Management for Co-occurring Alcohol Use Disorders and Serious Mental Illness. [2023]
Mobile telephone-delivered contingency management interventions promoting behaviour change in individuals with substance use disorders: a meta-analysis. [2021]
A systematic review of remotely delivered contingency management treatment for substance use. [2023]
Contingency management: utility in the treatment of drug abuse disorders. [2019]
Nationwide access to an internet-based contingency management intervention to promote smoking cessation: a randomized controlled trial. [2022]
Contingency management for alcohol use reduction: a pilot study using a transdermal alcohol sensor. [2022]
Automated Reinforcement Management System: Feasibility study findings of an app-based contingency management treatment for alcohol use disorder. [2023]
Technology-Based Contingency Management in the Treatment of Substance-Use Disorders. [2023]