Contingency Management for Alcohol Use Disorders
Primary Purpose
Alcohol Use Disorder, Contingency Management
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prize Contingency Management for Alcohol Abstinence
Standard 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 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
Sites / Locations
- The Hospital of Central Connecticut at New Britain General
- Farrell Treatment Center
- Behavioral Health Network, Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control Group
Experimental Group
Arm Description
Standard Care
Standard Care plus Prize Contingency Management for Alcohol Abstinence
Outcomes
Primary Outcome Measures
longest duration of abstinence from alcohol
objective report of alcohol use as measured by SCRAMx device
Secondary Outcome Measures
Full Information
NCT ID
NCT02135237
First Posted
February 24, 2014
Last Updated
October 30, 2019
Sponsor
UConn Health
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT02135237
Brief Title
Contingency Management for Alcohol Use Disorders
Official Title
Contingency Management for Alcohol Use Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
January 2014 (Actual)
Primary Completion Date
June 2019 (Actual)
Study Completion Date
June 2019 (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
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Standard Care
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
Standard Care plus Prize Contingency Management for Alcohol Abstinence
Intervention Type
Behavioral
Intervention Name(s)
Prize Contingency Management for Alcohol Abstinence
Intervention Description
The systematic reinforcement of desired behaviors and the withholding of reinforcement for undesired behaviors
Intervention Type
Behavioral
Intervention Name(s)
Standard Care
Primary Outcome Measure Information:
Title
longest duration of abstinence from alcohol
Description
objective report of alcohol use as measured by SCRAMx device
Time Frame
three 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheila Alessi, Ph.D.
Organizational Affiliation
UConn Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital of Central Connecticut at New Britain General
City
New Britain
State/Province
Connecticut
ZIP/Postal Code
06050
Country
United States
Facility Name
Farrell Treatment Center
City
New Britain
State/Province
Connecticut
ZIP/Postal Code
06051
Country
United States
Facility Name
Behavioral Health Network, Inc.
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01104
Country
United States
12. IPD Sharing Statement
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Contingency Management for Alcohol Use Disorders
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