- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02135237
Contingency Management for Alcohol Use Disorders
October 30, 2019 updated by: Sheila Alessi, UConn Health
Contingency management (CM) treatments are highly efficacious in improving outcomes of substance abusing patients.
However, CM has rarely been applied to individuals with alcohol use disorders, primarily because of technological limitations in monitoring drinking.
The Secure Continuous Remote Alcohol Monitor (SCRAMx®) is a new technology designed to continuously monitor alcohol consumption 24 hours a day for 7 days per week.
The purpose of this study is to evaluate the efficacy of CM in reducing alcohol use using SCRAMx.
In total, 120 alcohol abusing or dependent patients initiating outpatient treatment at community-based clinics will be randomly assigned to one of two conditions: standard care, or standard care plus CM with reinforcement based on results of SCRAMx readings.
Compared with standard care, it is expected that CM will result in fewer drinking days and longer durations of continuous non-drinking days.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
120
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
-
-
Connecticut
-
New Britain, Connecticut, United States, 06050
- The Hospital of Central Connecticut at New Britain General
-
New Britain, Connecticut, United States, 06051
- Farrell Treatment Center
-
-
Massachusetts
-
Springfield, Massachusetts, United States, 01104
- Behavioral Health Network, Inc.
-
-
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 18 years or older
- current diagnosis of alcohol use disorder and self report of recent alcohol use
- pass an informed consent quiz
- agree to wear a SCRAMx monitor for 12 weeks
- have a standard SCRAMx compatible phone line in their home or agree to attend the clinic weekly for brief research visits/downloads
- agree to sign an off-campus property transfer form and return SCRAMx equipment
Exclusion Criteria:
- serious, uncontrolled psychiatric illness
- in recovery from pathological gambling
- have an unstable address
- intend to participate in activities incompatible with SCRAMx over the next 3 months
- are wearing SCRAMx for legal purposes
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control Group
Standard Care
|
|
Experimental: Experimental Group
Standard Care plus Prize Contingency Management for Alcohol Abstinence
|
The systematic reinforcement of desired behaviors and the withholding of reinforcement for undesired behaviors
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
longest duration of abstinence from alcohol
Time Frame: three months
|
objective report of alcohol use as measured by SCRAMx device
|
three months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sheila Alessi, Ph.D., UConn Health
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 (Actual)
January 1, 2014
Primary Completion (Actual)
June 1, 2019
Study Completion (Actual)
June 1, 2019
Study Registration Dates
First Submitted
February 24, 2014
First Submitted That Met QC Criteria
May 7, 2014
First Posted (Estimate)
May 9, 2014
Study Record Updates
Last Update Posted (Actual)
November 1, 2019
Last Update Submitted That Met QC Criteria
October 30, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12-204H-2
- R01AA021446 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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