CM Treatment for Alcohol Dependence Using New Technology

NCT ID: NCT02143037

Last Updated: 2019-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2018-03-31

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.

Conditions

Alcohol Use Disorder; Contingency Management

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control Group

usual care

Group Type: ACTIVE_COMPARATOR

usual care

Intervention Type: BEHAVIORAL

Experimental Group

usual care plus prize contingency management for attending treatment

Group Type: EXPERIMENTAL

prize contingency management for attending treatment

Intervention Type: BEHAVIORAL

usual care

Intervention Type: BEHAVIORAL

Interventions

prize contingency management for attending treatment

Intervention Type: BEHAVIORAL

usual care

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

UConn Health

OTHER

Sponsor Role: lead

Responsible Party

Sheila Alessi

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sheila M Alessi, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

UConn Health

Locations

Regional Network of Programs, Inc.

Bridgeport, Connecticut, United States

Alcohol and Drug Recovery Centers, Inc.

Hartford, Connecticut, United States

Countries

United States

Other Identifiers

P60AA003510

Identifier Type: NIH

Identifier Source: secondary_id

View Link

13-040-2

Identifier Type: -

Identifier Source: org_study_id