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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02143037
Other study ID # 13-040-2
Secondary ID P60AA003510
Status Completed
Phase N/A
First received
Last updated
Start date May 2013
Est. completion date March 2018

Study information

Verified date May 2019
Source UConn Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 114
Est. completion date March 2018
Est. primary completion date March 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
prize contingency management for attending treatment

usual care


Locations

Country Name City State
United States Regional Network of Programs, Inc. Bridgeport Connecticut
United States Alcohol and Drug Recovery Centers, Inc. Hartford Connecticut

Sponsors (2)

Lead Sponsor Collaborator
UConn Health National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary longest duration of actively attending treatment patient attendance to treatment groups as verified by clinic records (number of days attended out of number of days expected to treatment) 3 months
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