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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Contingency Management | Experimental | Contingency Management plus treatment as usual |
|
| Non-contingent control group | No Intervention | Treatment as usual plus reinforcement for attendance |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contingency Management | Behavioral | Behavioral reinforcement for alcohol abstinence |
|
| Measure | Description | Time Frame |
|---|---|---|
| Alcohol Use as Assessed by Ethyl Glucuronide Detection in Urine | Mean EtG value (in ng/mL). 150ng/mL or above = EtG-positive, 149ng/mL or below = EtG-negative. EtG = ethyl glucuronide, alcohol biomarker detectable in urine. | Over 16 weeks of treatment (repeated measure) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Intensive Outpatient Substance Abuse Treatment Attendance | During 16 weeks of treatment | |
| Self Report Drug Use | through 7 months of study | |
| Other Drug Use as Measured by Urinalysis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard K Ries, MD | University of Washington | Principal Investigator |
| Michael McDonell, PhD | Washington State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Harborview Medical Center | Seattle | Washington | 98014 | United States |
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123 participants were enrolled, but only 79 met criteria to be randomized. Criteria for randomization included: EtG-positive urine sample during 4-week pre-randomization phase of the study, and adequate attendance during the pre-randomization phase.
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| ID | Title | Description |
|---|---|---|
| FG000 | Contingency Management | Contingency Management plus treatment as usual Contingency Management: Behavioral reinforcement for alcohol abstinence |
| FG001 | Non-contingent Control Group | Treatment as usual plus reinforcement for attendance |
| FG002 | Pre-randomization Drop-out | These participants were enrolled/consented in the study but not randomized to the Contingency Management or Control conditions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Contingency Management | Contingency Management plus treatment as usual Contingency Management: Behavioral reinforcement for alcohol abstinence |
| BG001 | Non-contingent Control Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Alcohol Use as Assessed by Ethyl Glucuronide Detection in Urine | Mean EtG value (in ng/mL). 150ng/mL or above = EtG-positive, 149ng/mL or below = EtG-negative. EtG = ethyl glucuronide, alcohol biomarker detectable in urine. | Posted | Mean | Standard Error | EtG Value (nanograms per milileter) | Over 16 weeks of treatment (repeated measure) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Contingency Management | Contingency Management plus treatment as usual Contingency Management: Behavioral reinforcement for alcohol abstinence |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael McDonell | Washington State University | 509 368-6967 | mmcdonell@wsu.edu |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D012559 | Schizophrenia |
| D001714 | Bipolar Disorder |
| D003865 | Depressive Disorder, Major |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
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| through 7 months of study |
| Community Outcomes | (jail bookings, ER visits, mental health and substance abuse service utilization) | entire study period, and three month prior and after study involvement |
| Psychiatric Symptomology | Brief Symptom Inventory; Positive and Negative Symptom Scale | throughout 7 months of study |
Treatment as usual plus reinforcement for attendance
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Change in Intensive Outpatient Substance Abuse Treatment Attendance | Posted | Mean | Standard Deviation | percentage of addiction tx attended | During 16 weeks of treatment |
|
|
|
| Secondary | Self Report Drug Use | Not Posted | through 7 months of study | Participants |
| Secondary | Other Drug Use as Measured by Urinalysis | Not Posted | through 7 months of study | Participants |
| Secondary | Community Outcomes | (jail bookings, ER visits, mental health and substance abuse service utilization) | Not Posted | entire study period, and three month prior and after study involvement | Participants |
| Secondary | Psychiatric Symptomology | Brief Symptom Inventory; Positive and Negative Symptom Scale | Not Posted | throughout 7 months of study | Participants |
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Non-contingent Control Group | Treatment as usual plus reinforcement for attendance | 0 | 39 | 0 | 39 |
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| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D003866 | Depressive Disorder |