Alcohol Abuse, Bipolar Disorder, Major Depressive Disorder, Schizophrenia
Conditions
Keywords
alcohol abuse, drug abuse, schizophrenia, bipolar disorder, major depressive disorder, contingency management, psychosocial treatment
Brief 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.
Interventions
BEHAVIORALContingency Management
Behavioral reinforcement for alcohol abstinence
Sponsors
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Currently receiving psychiatric \[AND intensive outpatient addiction treatment\] at Community Psychiatric Clinic (CPC). 2. Aged 18 to 65 years. 3. Ability to understand written and spoken English language. 4. DSM-IV diagnosis of alcohol dependence as assessed by the MINI psychiatric interview. 5. Diagnosis of current serious mental illness: schizophrenia, schizoaffective disorders, bipolar disorder I or II, or recurring major depressive disorders as assessed by the MINI psychiatric interview. 6. Alcohol use in the month prior to study entry: self-reported alcohol use of 5 days or more during the 30 days prior to study entry (5 drinking days/month is selected based on previous research reporting alcohol use in 18% of days assessed in a sample of psychiatric outpatients with co-occurring SUDs & SMI).120 7. A CPC treating clinician must affirm the potential participant is safe to participate in the study.
Exclusion criteria
1. A significant risk of dangerous alcohol withdrawal: a history of alcohol detoxification or seizure in the last 12 months AND participant or clinician concern that abstinence will induce dangerous alcohol withdrawal. 2. DSM-IV diagnosis of current (last year) drug dependence as assessed by the MINI interview. 3. Any medical/psychiatric condition, or severity of that condition, that in the opinion of the PI, would compromise safe study participation. 4. Chart defined organic brain disorder or dementia. 5. Inability to provide informed consent as measured by the University of California San Diego Brief Assessment of Capacity to Consent (UBACC), a tool designed to screen for ability to provide informed consent for research. If indicated by the UBACC screening process, the more comprehensive MacCAT-CR will be used.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Alcohol Use as Assessed by Ethyl Glucuronide Detection in Urine | Over 16 weeks of treatment (repeated measure) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | through 7 months of study | — |
| Community Outcomes | entire study period, and three month prior and after study involvement | (jail bookings, ER visits, mental health and substance abuse service utilization) |
| Psychiatric Symptomology | throughout 7 months of study | Brief Symptom Inventory; Positive and Negative Symptom Scale |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Contingency Management Contingency Management plus treatment as usual
Contingency Management: Behavioral reinforcement for alcohol abstinence | 40 |
| Non-contingent Control Group Treatment as usual plus reinforcement for attendance | 39 |
| Total | 79 |
Baseline characteristics
| Characteristic | Non-contingent Control Group | Contingency Management | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 39 Participants | 40 Participants | 79 Participants |
| Age, Continuous | 46.23 years STANDARD_DEVIATION 10.55 | 44.55 years STANDARD_DEVIATION 9.92 | 45.38 years STANDARD_DEVIATION 10.24 |
| Gender Female | 15 Participants | 14 Participants | 29 Participants |
| Gender Male | 24 Participants | 26 Participants | 50 Participants |
| Region of Enrollment United States | 39 Participants | 40 Participants | 79 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 40 | 0 / 39 |
| serious Total, serious adverse events | 0 / 40 | 0 / 39 |
Outcome results
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.
Time frame: Over 16 weeks of treatment (repeated measure)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Contingency Management | Alcohol Use as Assessed by Ethyl Glucuronide Detection in Urine | 408.86 EtG Value (nanograms per milileter) | Standard Error 39.57 |
| Non-contingent Control Group | Alcohol Use as Assessed by Ethyl Glucuronide Detection in Urine | 734.79 EtG Value (nanograms per milileter) | Standard Error 40.66 |
Secondary
Change in Intensive Outpatient Substance Abuse Treatment Attendance
Time frame: During 16 weeks of treatment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Contingency Management | Change in Intensive Outpatient Substance Abuse Treatment Attendance | 57 percentage of addiction tx attended | Standard Deviation 34 |
| Non-contingent Control Group | Change in Intensive Outpatient Substance Abuse Treatment Attendance | 53 percentage of addiction tx attended | Standard Deviation 37 |
Secondary
Community Outcomes
(jail bookings, ER visits, mental health and substance abuse service utilization)
Time frame: entire study period, and three month prior and after study involvement
Secondary
Other Drug Use as Measured by Urinalysis
Time frame: through 7 months of study
Secondary
Psychiatric Symptomology
Brief Symptom Inventory; Positive and Negative Symptom Scale
Time frame: throughout 7 months of study
Secondary
Self Report Drug Use
Time frame: through 7 months of study