Clinical Trials Directory

Trials / Completed

CompletedNCT01567943

Contingency Management of Alcohol Abuse in the Severely Mentally ILL

Novel EtG-Based Contingency Management for Alcohol in the Severely Mentally Ill

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
123 (actual)
Sponsor
University of Washington · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

Summary

The investigators will evaluate the efficacy of a comprehensive 12-week contingency management intervention for treating alcohol dependence for persons with severe mental illness who are seen within the context of a community mental health center setting. The primary contingency will be submission of alcohol-free urines. Additional reinforcers will be provided for intensive outpatient addiction treatment attendance. Reinforcers will be vouchers or actual items useful for day-to-day living. Participants will be 120 adults diagnosed with alcohol dependance and severe mental illness.

Detailed description

The contingency management (CM) paradigm that will be used is the variable magnitude of reinforcement procedure. In order to encourage engagement in study procedures and reduce dropout in the randomized sample, all participants will undergo a 4-week pre-randomization induction period. During the induction period, participants will be reinforced for providing urine-tests three times a week. Those who demonstrate study participation and need for treatment during the induction period will be randomized to receive treatment as usual and either 1) 12 weeks of CM for alcohol abstinence (assessed by Ethyl glucuronide immunoassay urine-test) AND weekly reinforcement for intensive outpatient addiction treatment attendance; or 2) 12 weeks of reinforcement for providing urine-samples and continued study involvement. Randomization will be used to assign participants to treatment conditions. The primary outcome will be changes in alcohol use assessed by Ehyl glucuronide immunoassay urine-tests, breath-tests, as well as self- and clinician-reported alcohol use. The secondary outcome will be changes in intensive outpatient group attendance assessed by intensive outpatient clinician-report, as well as administrative data sources, and self-report. Other outcomes will include: urine-tests and self-reported illicit drug use, psychiatric symptoms, other outpatient treatment utilization, HIV-risk, and nicotine use. All outcomes will be assessed \[for 4-weeks prior to study enrollment (self-report, clinician ratings etc)\] and throughout the 4-week induction, 12-week intervention, and 3-month follow-up periods.

Conditions

Interventions

TypeNameDescription
BEHAVIORALContingency ManagementBehavioral reinforcement for alcohol abstinence

Timeline

Start date
2012-03-01
Primary completion
2015-02-01
Completion
2016-02-01
First posted
2012-03-30
Last updated
2017-02-23
Results posted
2017-01-05

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01567943. Inclusion in this directory is not an endorsement.