- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01307345
Remote Monitoring and Contingency Management Reinforcement for Alcohol Abstinence
July 18, 2018 updated by: UConn Health
This pilot project proposes to monitor real-world alcohol use using a novel technology-cell phone videorecordings in conjunction with breathalyzer recordings-and to conduct a small randomized study of this technology for reinforcing alcohol abstinence.
Individuals with frequent alcohol use (N = 30) will be asked to carry a study cell phone plus a handheld breathalyzer for one month.
Participants will be randomized to one of two conditions: alcohol monitoring or alcohol monitoring plus contingency management.
In both conditions, research assistants will telephone participants on their cell phone an average of 10 times per week to request submission of a breathalyzer sample using the video monitoring function on the cell phone.
Samples will be time and date stamped, and the video containing the breathalyzer result will be sent to study staff via the cell phone.
Participants will be compensated for each video recorded within one hour of receiving the prompt.
Participants randomized to the contingency management condition will receive the same alcohol monitoring described above, and they will also receive reinforcement for each alcohol negative breath sample submitted within one hour of the prompt.
Data from this pilot project will be useful for (1) determining the feasibility of assessing alcohol use in the natural environment via breathalyzers and cell phone technology, and (2) estimating effect sizes of a CM intervention that reinforces alcohol abstinence using breathalyzers and cell phone technology.
In an exploratory manner, we will also evaluate the reliability and validity of the video monitoring procedure and trends toward changes in psychosocial functioning.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Connecticut
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Farmington, Connecticut, United States, 06030-3944
- University of Connecticut Health Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- age >21 years
- frequent alcohol use
- willing to use a cell phone and breathalyzer for 28 days
- have a valid photo ID (driver's license, passport, state ID)
- are willing to sign an off-campus property transfer form and return study equipment in four weeks
Exclusion Criteria:
- desire for, or have received, treatment for alcohol use in the past 6 months
- non-English speaking
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Monitoring Alone
Research assistants will phone or text participants and request videorecordings of breathalyzer samples up to 21 times per week.
Participants will receive compensation for each valid videorecording that occurs within the requested one-hour time frame, and bonus compensation each time all requested videorecordings are submitted within the timeframe over a 7-day period, and/or if >90% of prompts are returned over the study period.
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Experimental: Monitoring plus contingency management for abstinence
Participants assigned to this condition will receive the same monitoring schedule outlined above, plus the same payment for compliance.
In addition, they will receive contingent reinforcement for submission of videorecordings that demonstrate negative breath alcohol samples.
For each sample submitted that reads below the cut point, participants will receive vouchers for payment.
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For each breath sample submitted that reads below the cut point, participants will receive a voucher that can be exchanged for a check or gift card.
Amounts earned will increase for each consecutive negative sample submitted, up to a maximum amount.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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proportion of negative breath samples submitted
Time Frame: Week 4
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Week 4
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Sheila Alessi, Ph.D., University of Conncecticut Health Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2011
Primary Completion (Actual)
September 1, 2011
Study Completion (Actual)
September 1, 2011
Study Registration Dates
First Submitted
February 28, 2011
First Submitted That Met QC Criteria
February 28, 2011
First Posted (Estimate)
March 2, 2011
Study Record Updates
Last Update Posted (Actual)
July 20, 2018
Last Update Submitted That Met QC Criteria
July 18, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11-058-1
- P30DA023918 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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