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Dual Reinforcement Contingency Management for Alcohol Use Disorders (Peth)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04064463
Recruitment Status : Suspended (due to COVID-19)
First Posted : August 22, 2019
Last Update Posted : April 15, 2020
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Sheila Alessi, UConn Health

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.

Condition or disease Intervention/treatment Phase
Alcohol Use Disorder Contingency Management Behavioral: Standard care Behavioral: Contingency management Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dual Reinforcement Contingency Management for Alcohol Use Disorders
Actual Study Start Date : January 22, 2020
Estimated Primary Completion Date : August 2024
Estimated Study Completion Date : August 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arm Intervention/treatment
Active Comparator: Control Group
Standard care
Behavioral: Standard care
standard treatment for substance use disorders, along with sample monitoring

Experimental: Experimental Group
Standard care plus contingency management
Behavioral: Standard care
standard treatment for substance use disorders, along with sample monitoring

Behavioral: Contingency management
Participants can earn reinforcement for attending group and abstinence from alcohol




Primary Outcome Measures :
  1. Group attendance [ Time Frame: 12 weeks ]
    longest consecutive days attended groups

  2. Alcohol abstinence [ Time Frame: 12 weeks ]
    number of negative PEth samples



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04064463


Locations
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United States, Connecticut
The Village
Hartford, Connecticut, United States, 06105
Sponsors and Collaborators
UConn Health
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Principal Investigator: Sheila Alessi, Ph.D. UConn Health
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Responsible Party: Sheila Alessi, Associate Professor, UConn Health
ClinicalTrials.gov Identifier: NCT04064463    
Other Study ID Numbers: 19-146-2
First Posted: August 22, 2019    Key Record Dates
Last Update Posted: April 15, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alcoholism
Alcohol Drinking
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders