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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04064463
Recruitment Status : Recruiting
First Posted : August 22, 2019
Last Update Posted : August 14, 2020
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Sheila Alessi, UConn Health

Tracking Information
First Submitted Date  ICMJE August 20, 2019
First Posted Date  ICMJE August 22, 2019
Last Update Posted Date August 14, 2020
Actual Study Start Date  ICMJE January 22, 2020
Estimated Primary Completion Date August 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 20, 2019)
  • Group attendance [ Time Frame: 12 weeks ]
    longest consecutive days attended groups
  • Alcohol abstinence [ Time Frame: 12 weeks ]
    number of negative PEth samples
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dual Reinforcement Contingency Management for Alcohol Use Disorders
Official Title  ICMJE Dual Reinforcement Contingency Management for Alcohol Use Disorders
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Alcohol Use Disorder
  • Contingency Management
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: Control Group
    Standard care
    Intervention: Behavioral: Standard care
  • Experimental: Experimental Group
    Standard care plus contingency management
    Interventions:
    • Behavioral: Standard care
    • Behavioral: Contingency management
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 20, 2019)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2024
Estimated Primary Completion Date August 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • in intensive outpatient treatment
  • DSM-5 diagnosis of an alcohol use disorder

Exclusion Criteria:

  • have a condition that may hinder study participation
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ruth Fetter 860-679-4556 fetter@uchc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04064463
Other Study ID Numbers  ICMJE 19-146-2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sheila Alessi, UConn Health
Study Sponsor  ICMJE UConn Health
Collaborators  ICMJE National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators  ICMJE
Principal Investigator: Sheila Alessi, Ph.D. UConn Health
PRS Account UConn Health
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP