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Contingency Management for Alcohol Use Disorders

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: NCT02135237
Recruitment Status : Completed
First Posted : May 9, 2014
Last Update Posted : November 1, 2019
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 February 24, 2014
First Posted Date  ICMJE May 9, 2014
Last Update Posted Date November 1, 2019
Actual Study Start Date  ICMJE January 2014
Actual Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 7, 2014)
longest duration of abstinence from alcohol [ Time Frame: three months ]
objective report of alcohol use as measured by SCRAMx device
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 Contingency Management for Alcohol Use Disorders
Official Title  ICMJE Contingency Management for Alcohol Use Disorders
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.
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: Prize Contingency Management for Alcohol Abstinence
    The systematic reinforcement of desired behaviors and the withholding of reinforcement for undesired behaviors
  • Behavioral: Standard Care
Study Arms  ICMJE
  • Active Comparator: Control Group
    Standard Care
    Intervention: Behavioral: Standard Care
  • Experimental: Experimental Group
    Standard Care plus Prize Contingency Management for Alcohol Abstinence
    Interventions:
    • Behavioral: Prize Contingency Management for Alcohol Abstinence
    • Behavioral: Standard Care
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 Completed
Actual Enrollment  ICMJE
 (submitted: May 7, 2014)
120
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2019
Actual Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02135237
Other Study ID Numbers  ICMJE 12-204H-2
R01AA021446 ( U.S. NIH Grant/Contract )
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 October 2019

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