CM Treatment for Alcohol Dependence Using New Technology

May 15, 2019 updated by: Sheila Alessi, UConn Health

Contingency management (CM) is highly efficacious for reducing substance use, and recent data suggest that reinforcing attendance at treatment can significantly improve treatment outcomes. Importantly, CM interventions that reinforce attendance are more likely to be adopted clinically than those that reinforce abstinence. Having objective indicators of drinking outcomes, nevertheless, is critical for quantifying the benefits of attendance-based CM treatment in alcohol abusing populations. New technology is now available to gauge alcohol use in patients' natural environments. The Secure Continuous Remote Alcohol Monitor (SCRAMx®) continuously monitors alcohol consumption 24 hours a day. As such, it may be ideal for objective evaluation of alcohol consumption during treatment intervention studies, including those that involve CM.

In this study, 114 patients participating in community based outpatient treatment programs for alcohol use disorders will wear SCRAMx for a 12-week period. They will be randomized to standard care or standard care plus CM, with reinforcement contingent upon attendance at treatment. The investigators will assess treatment attendance and alcohol use via SCRAMx and self reports. The investigators expect that patients randomized to the CM intervention will remain in treatment longer and show reductions in both SCRAMx assessed and self reported drinking days relative to those randomized to standard care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

114

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Bridgeport, Connecticut, United States, 06610
        • Regional Network of Programs, Inc.
      • Hartford, Connecticut, United States, 06112
        • Alcohol and Drug Recovery Centers, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age 18 years or older
  • current diagnosis of alcohol use disorder
  • able to 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 at least every other week for data downloads
  • agree to sign an off-campus property transfer form and return SCRAMx equipment in 12 weeks

Exclusion Criteria:

  • serious, uncontrolled psychiatric illness
  • in recovery from pathological gambling
  • unstable address
  • intend to participate in activities incompatible with SCRAMx in the next 3 months
  • are wearing SCRAMx for legal purposes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Group
usual care
Behavioral: usual care
Experimental: Experimental Group
usual care plus prize contingency management for attending treatment
Behavioral: usual care
Behavioral: prize contingency management for attending treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
longest duration of actively attending treatment
Time Frame: 3 months
patient attendance to treatment groups as verified by clinic records (number of days attended out of number of days expected to treatment)
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UConn Health

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

  • Principal Investigator: Sheila M Alessi, Ph.D., UConn Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2013

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

February 24, 2014

First Submitted That Met QC Criteria

May 19, 2014

First Posted (Estimate)

May 20, 2014

Study Record Updates

Last Update Posted (Actual)

May 17, 2019

Last Update Submitted That Met QC Criteria

May 15, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-040-2
  • P60AA003510 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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