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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02135237
Other study ID # 12-204H-2
Secondary ID R01AA021446
Status Completed
Phase N/A
First received
Last updated
Start date January 2014
Est. completion date June 2019

Study information

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

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date June 2019
Est. primary completion date June 2019
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 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

Study Design


Intervention

Behavioral:
Prize Contingency Management for Alcohol Abstinence
The systematic reinforcement of desired behaviors and the withholding of reinforcement for undesired behaviors
Standard Care


Locations

Country Name City State
United States Farrell Treatment Center New Britain Connecticut
United States The Hospital of Central Connecticut at New Britain General New Britain Connecticut
United States Behavioral Health Network, Inc. Springfield Massachusetts

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 abstinence from alcohol objective report of alcohol use as measured by SCRAMx device three months
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