NCT02143037

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 20, 2014

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

May 17, 2019

Status Verified

May 1, 2019

Enrollment Period

4.8 years

First QC Date

February 24, 2014

Last Update Submit

May 15, 2019

Conditions

Alcohol Use DisorderContingency Management

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Control Group

ACTIVE COMPARATOR

usual care

Behavioral: usual care

Experimental Group

EXPERIMENTAL

usual care plus prize contingency management for attending treatment

Behavioral: prize contingency management for attending treatmentBehavioral: usual care

Interventions

prize contingency management for attending treatmentBEHAVIORAL
Experimental Group
usual careBEHAVIORAL
Control GroupExperimental Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Regional Network of Programs, Inc.

Bridgeport, Connecticut, 06610, United States

Location

Alcohol and Drug Recovery Centers, Inc.

Hartford, Connecticut, 06112, United States

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Sheila M Alessi, Ph.D.

    UConn Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 24, 2014

First Posted

May 20, 2014

Study Start

May 1, 2013

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

May 17, 2019

Record last verified: 2019-05

Locations

US(2)