Dual Reinforcement Contingency Management for Alcohol Use Disorders (Peth)
Primary Purpose
Alcohol Use Disorder, Contingency Management
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard care
Contingency management
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Use Disorder
Eligibility Criteria
Inclusion Criteria:
- in intensive outpatient treatment
- DSM-5 diagnosis of an alcohol use disorder
Exclusion Criteria:
- have a condition that may hinder study participation
Sites / Locations
- The VillageRecruiting
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 contingency management
Outcomes
Primary Outcome Measures
Group attendance
longest consecutive days attended groups
Alcohol abstinence
number of negative PEth samples
Secondary Outcome Measures
Full Information
NCT ID
NCT04064463
First Posted
August 20, 2019
Last Updated
March 22, 2023
Sponsor
UConn Health
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT04064463
Brief Title
Dual Reinforcement Contingency Management for Alcohol Use Disorders
Acronym
Peth
Official Title
Dual Reinforcement Contingency Management for Alcohol Use Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 22, 2020 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)
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
Phosphatidylethanol (PEth) is a direct biomarker of alcohol that can detect moderate to heavy drinking with high sensitivity and specificity over 3-week periods. Reinforcing negative PEth results alongside attendance may increase the proportion of participants who respond to CM during and post treatment. In the proposed study, the investigators will collect PEth samples every 3 weeks for 12 weeks in 150 participants initiating outpatient treatment for alcohol use disorders. Using a two-group randomized design, participants will be assigned to standard care with PEth monitoring alone or with CM for attending treatment and submitting PEth negative samples. Compared to standard care and monitoring, the investigators expect that the CM intervention will result in greater attendance, more PEth negative samples, and higher proportions of self-reported non-drinking days, along with lower proportions of heavy drinking days, over the short term and the long term, measured throughout a 12-month follow-up. The investigators anticipate that the reinforcement intervention may decrease other drug use and sexual risk behaviors that spread HIV, reduce psychiatric symptoms, and improve quality of life as well.
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
150 (Anticipated)
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 contingency management
Intervention Type
Behavioral
Intervention Name(s)
Standard care
Intervention Description
standard treatment for substance use disorders, along with sample monitoring
Intervention Type
Behavioral
Intervention Name(s)
Contingency management
Intervention Description
Participants can earn reinforcement for attending group and abstinence from alcohol
Primary Outcome Measure Information:
Title
Group attendance
Description
longest consecutive days attended groups
Time Frame
12 weeks
Title
Alcohol abstinence
Description
number of negative PEth samples
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
in intensive outpatient treatment
DSM-5 diagnosis of an alcohol use disorder
Exclusion Criteria:
have a condition that may hinder study participation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ruth Fetter
Phone
860-679-4556
Email
fetter@uchc.edu
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 Village
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruth Fetter
Phone
860-679-4556
Email
fetter@Uchc.edu
12. IPD Sharing Statement
Learn more about this trial
Dual Reinforcement Contingency Management for Alcohol Use Disorders
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