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CM Treatment for Alcohol Dependence Using New Technology

Primary Purpose

Alcohol Use Disorder, Contingency Management

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
prize contingency management for attending treatment
usual care
Sponsored by
UConn Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Regional Network of Programs, Inc.
  • Alcohol and Drug Recovery Centers, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Group

Experimental Group

Arm Description

usual care

usual care plus prize contingency management for attending treatment

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
February 24, 2014
Last Updated
May 15, 2019
Sponsor
UConn Health
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT02143037
Brief Title
CM Treatment for Alcohol Dependence Using New Technology
Official Title
CM Treatment for Alcohol Dependence Using New Technology
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
May 2013 (Actual)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
March 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UConn Health
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder, Contingency Management

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
usual care
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
usual care plus prize contingency management for attending treatment
Intervention Type
Behavioral
Intervention Name(s)
prize contingency management for attending treatment
Intervention Type
Behavioral
Intervention Name(s)
usual care
Primary Outcome Measure Information:
Title
longest duration of actively attending treatment
Description
patient attendance to treatment groups as verified by clinic records (number of days attended out of number of days expected to treatment)
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sheila M Alessi, Ph.D.
Organizational Affiliation
UConn Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Regional Network of Programs, Inc.
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06610
Country
United States
Facility Name
Alcohol and Drug Recovery Centers, Inc.
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06112
Country
United States

12. IPD Sharing Statement

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CM Treatment for Alcohol Dependence Using New Technology

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