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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04064463
Other study ID # 19-146-2
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 22, 2020
Est. completion date May 2025

Study information

Verified date April 2024
Source UConn Health
Contact Ruth Fetter
Phone 860-679-4556
Email fetter@uchc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date May 2025
Est. primary completion date May 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - in intensive outpatient treatment - DSM-5 diagnosis of an alcohol use disorder Exclusion Criteria: - have a condition that may hinder study participation

Study Design


Intervention

Behavioral:
Standard care
standard treatment for substance use disorders, along with sample monitoring
Contingency management
Participants can earn reinforcement for attending group and abstinence from alcohol

Locations

Country Name City State
United States The Village Hartford Connecticut

Sponsors (2)

Lead Sponsor Collaborator
UConn Health National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Group attendance longest consecutive days attended groups 12 weeks
Primary Alcohol abstinence number of negative PEth samples 12 weeks
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