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Contingency Management of Alcohol Abuse in the Severely Mentally ILL (CMETG)

Primary Purpose

Alcohol Abuse, Schizophrenia, Bipolar Disorder

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Contingency Management

About this trial

This is an interventional treatment trial for Alcohol Abuse focused on measuring alcohol abuse, drug abuse, schizophrenia, bipolar disorder, major depressive disorder, contingency management, psychosocial treatment

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Currently receiving psychiatric [AND intensive outpatient addiction treatment] at Community Psychiatric Clinic (CPC).
Aged 18 to 65 years.
Ability to understand written and spoken English language.
DSM-IV diagnosis of alcohol dependence as assessed by the MINI psychiatric interview.
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.
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
A CPC treating clinician must affirm the potential participant is safe to participate in the study.

Exclusion Criteria:

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.
DSM-IV diagnosis of current (last year) drug dependence as assessed by the MINI interview.
Any medical/psychiatric condition, or severity of that condition, that in the opinion of the PI, would compromise safe study participation.
Chart defined organic brain disorder or dementia.
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.

Sites / Locations

Harborview Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Contingency Management

Non-contingent control group

Arm Description

Contingency Management plus treatment as usual

Treatment as usual plus reinforcement for attendance

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in Intensive Outpatient Substance Abuse Treatment Attendance

Self Report Drug Use

Other Drug Use as Measured by Urinalysis

Community Outcomes

(jail bookings, ER visits, mental health and substance abuse service utilization)

Psychiatric Symptomology

Brief Symptom Inventory; Positive and Negative Symptom Scale

Full Information

NCT ID

NCT01567943

First Posted

March 26, 2012

Last Updated

January 5, 2017

Sponsor

University of Washington

1. Study Identification

Unique Protocol Identification Number

NCT01567943

Brief Title

Contingency Management of Alcohol Abuse in the Severely Mentally ILL

Acronym

CMETG

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

March 2012 (undefined)

Primary Completion Date

February 2015 (Actual)

Study Completion Date

February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Washington

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alcohol Abuse, Schizophrenia, Bipolar Disorder, Major Depressive Disorder

Keywords

alcohol abuse, drug abuse, schizophrenia, bipolar disorder, major depressive disorder, contingency management, psychosocial treatment

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

123 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Contingency Management

Arm Type

Experimental

Arm Description

Contingency Management plus treatment as usual

Arm Title

Non-contingent control group

Arm Type

No Intervention

Arm Description

Treatment as usual plus reinforcement for attendance

Intervention Type

Behavioral

Intervention Name(s)

Contingency Management

Intervention Description

Behavioral reinforcement for alcohol abstinence

Primary Outcome Measure Information:

Title

Alcohol Use as Assessed by Ethyl Glucuronide Detection in Urine

Description

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)

Secondary Outcome Measure Information:

Title

Change in Intensive Outpatient Substance Abuse Treatment Attendance

Time Frame

During 16 weeks of treatment

Title

Self Report Drug Use

Time Frame

through 7 months of study

Title

Other Drug Use as Measured by Urinalysis

Time Frame

through 7 months of study

Title

Community Outcomes

Description

(jail bookings, ER visits, mental health and substance abuse service utilization)

Time Frame

entire study period, and three month prior and after study involvement

Title

Psychiatric Symptomology

Description

Brief Symptom Inventory; Positive and Negative Symptom Scale

Time Frame

throughout 7 months of study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Currently receiving psychiatric [AND intensive outpatient addiction treatment] at Community Psychiatric Clinic (CPC). Aged 18 to 65 years. Ability to understand written and spoken English language. DSM-IV diagnosis of alcohol dependence as assessed by the MINI psychiatric interview. 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. 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 A CPC treating clinician must affirm the potential participant is safe to participate in the study. Exclusion Criteria: 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. DSM-IV diagnosis of current (last year) drug dependence as assessed by the MINI interview. Any medical/psychiatric condition, or severity of that condition, that in the opinion of the PI, would compromise safe study participation. Chart defined organic brain disorder or dementia. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Richard K Ries, MD

Organizational Affiliation

University of Washington

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Michael McDonell, PhD

Organizational Affiliation

Washington State University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Harborview Medical Center

City

Seattle

State/Province

Washington

ZIP/Postal Code

98014

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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