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CM Treatment for Alcohol Dependence Using New Technology

Sponsor
UConn Health (Other)
Overall Status
Completed
CT.gov ID
NCT02143037
Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA) (NIH)
114
Enrollment
2
Locations
2
Arms
58
Actual Duration (Months)
57
Patients Per Site
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: prize contingency management for attending treatment
  • Behavioral: usual care
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
114 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
CM Treatment for Alcohol Dependence Using New Technology
Actual Study Start Date :
May 1, 2013
Actual Primary Completion Date :
Mar 1, 2018
Actual Study Completion Date :
Mar 1, 2018

Arms and Interventions

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: prize contingency management for attending treatment

Behavioral: usual care

Outcome Measures

Primary Outcome Measures

  1. longest duration of actively attending treatment [3 months]

    patient attendance to treatment groups as verified by clinic records (number of days attended out of number of days expected to treatment)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Regional Network of Programs, Inc. Bridgeport Connecticut United States 06610
2 Alcohol and Drug Recovery Centers, Inc. Hartford Connecticut United States 06112

Sponsors and Collaborators

  • UConn Health
  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sheila Alessi, Associate Professor, UConn Health
ClinicalTrials.gov Identifier:
NCT02143037
Other Study ID Numbers:
  • 13-040-2
  • P60AA003510
First Posted:
May 20, 2014
Last Update Posted:
May 17, 2019
Last Verified:
May 1, 2019
Additional relevant MeSH terms:
Alcoholism

Study Results

No Results Posted as of May 17, 2019