CM Treatment for Alcohol Dependence Using New Technology
Primary Purpose
Alcohol Use Disorder, Contingency Management
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
prize contingency management for attending treatment
usual care
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Use Disorder
Eligibility Criteria
Inclusion Criteria:
- age 18 years or older
- current diagnosis of alcohol use disorder
- able to 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 at least every other week for data downloads
- agree to sign an off-campus property transfer form and return SCRAMx equipment in 12 weeks
Exclusion Criteria:
- serious, uncontrolled psychiatric illness
- in recovery from pathological gambling
- unstable address
- intend to participate in activities incompatible with SCRAMx in the next 3 months
- are wearing SCRAMx for legal purposes
Sites / Locations
- Regional Network of Programs, Inc.
- Alcohol and Drug Recovery Centers, Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control Group
Experimental Group
Arm Description
usual care
usual care plus prize contingency management for attending treatment
Outcomes
Primary Outcome Measures
longest duration of actively attending treatment
patient attendance to treatment groups as verified by clinic records (number of days attended out of number of days expected to treatment)
Secondary Outcome Measures
Full Information
NCT ID
NCT02143037
First Posted
February 24, 2014
Last Updated
May 15, 2019
Sponsor
UConn Health
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT02143037
Brief Title
CM Treatment for Alcohol Dependence Using New Technology
Official Title
CM Treatment for Alcohol Dependence Using New Technology
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
May 2013 (Actual)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UConn Health
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Contingency management (CM) is highly efficacious for reducing substance use, and recent data suggest that reinforcing attendance at treatment can significantly improve treatment outcomes. Importantly, CM interventions that reinforce attendance are more likely to be adopted clinically than those that reinforce abstinence. Having objective indicators of drinking outcomes, nevertheless, is critical for quantifying the benefits of attendance-based CM treatment in alcohol abusing populations. New technology is now available to gauge alcohol use in patients' natural environments. The Secure Continuous Remote Alcohol Monitor (SCRAMx®) continuously monitors alcohol consumption 24 hours a day. As such, it may be ideal for objective evaluation of alcohol consumption during treatment intervention studies, including those that involve CM.
In this study, 114 patients participating in community based outpatient treatment programs for alcohol use disorders will wear SCRAMx for a 12-week period. They will be randomized to standard care or standard care plus CM, with reinforcement contingent upon attendance at treatment. The investigators will assess treatment attendance and alcohol use via SCRAMx and self reports. The investigators expect that patients randomized to the CM intervention will remain in treatment longer and show reductions in both SCRAMx assessed and self reported drinking days relative to those randomized to standard care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder, Contingency Management
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
114 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
usual care
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
usual care plus prize contingency management for attending treatment
Intervention Type
Behavioral
Intervention Name(s)
prize contingency management for attending treatment
Intervention Type
Behavioral
Intervention Name(s)
usual care
Primary Outcome Measure Information:
Title
longest duration of actively attending treatment
Description
patient attendance to treatment groups as verified by clinic records (number of days attended out of number of days expected to treatment)
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age 18 years or older
current diagnosis of alcohol use disorder
able to 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 at least every other week for data downloads
agree to sign an off-campus property transfer form and return SCRAMx equipment in 12 weeks
Exclusion Criteria:
serious, uncontrolled psychiatric illness
in recovery from pathological gambling
unstable address
intend to participate in activities incompatible with SCRAMx in the next 3 months
are wearing SCRAMx for legal purposes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheila M Alessi, Ph.D.
Organizational Affiliation
UConn Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Regional Network of Programs, Inc.
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06610
Country
United States
Facility Name
Alcohol and Drug Recovery Centers, Inc.
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06112
Country
United States
12. IPD Sharing Statement
Learn more about this trial
CM Treatment for Alcohol Dependence Using New Technology
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