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Individualizing Incentives for Alcohol in the Severely Mentally Ill

Primary Purpose

Schizophrenia, Bipolar Disorder, Major Depressive Disorder

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Usual CM
High-Magnitude CM
Shaping CM
Sponsored by
Washington State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Aged 18 to 65 years.
  2. 4 or more standard drinks for females (AFAB)/ 5 or more standard drinks for males (AMAB) on 5 or more occasions in the past 30 days.
  3. DSM-5 diagnosis of moderate to severe alcohol use disorder.
  4. DSM-5 diagnosis of schizophrenia or schizoaffective disorder, bipolar I or II, or recurrent major depressive disorder (>1 episode).

Exclusion Criteria:

  1. Current DSM-5 diagnosis of a severe substance use disorder for any substances used within the past 30 days
  2. A significant risk of medically dangerous alcohol withdrawal (e.g. a history of seizures in the last 12 months, participant or clinician concern that abstinence will induce dangerous alcohol withdrawal).
  3. Any medical/psychiatric condition, or severity of that condition, that in the opinion of the PI, would compromise safe study participation.
  4. Inability to provide informed consent as measured by the MacCAT-CR. (e.g. dementia)
  5. Pregnant or planning to become pregnant.

Sites / Locations

  • Sound Health
  • WSU Research Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Usual CM

High-Magnitude CM

Shaping CM

Arm Description

Participants will earn at least 3 prize draws each time they submit an alcohol negative urine samples during weeks 5-20, plus treatment as usual

Participants will earn twice as many prize draws than those in the Usual CM for alcohol abstinence during weeks 5-20, plus treatment as usual.

Participants will earn prize draws for light drinking during weeks 5-8 instead of alcohol abstinence and will then earn prize draws for abstinence during weeks 9-20, plus treatment as usual.

Outcomes

Primary Outcome Measures

Alcohol use assessed by ethyl glucuronide (EtG) detection in urine
Mean EtG value (in ng/mL). EtG <150 ng/mL = EtG-negative, EtG >149 ng/mL = EtG-positive, EtG <500 ng/mL = light drinking, EtG >499 ng/mL = heavy drinking

Secondary Outcome Measures

Positive and Negative Syndrome Scale
Psychiatric symptomology
Urinanalysis for Drug Use
Urine tests for drug use
Addiction Severity Index (ASI)
Alcohol and drug addiction severity
Alcohol and Cigarette Timeline Followback
Alcohol and Cigarette Use
Fagerstrom Test of Nicotine Dependence
Presence and severity of nicotine dependence
Housing Timeline FollowBack
Assess homelessness
Brief HIV Risk Behavior Scale
HIV risk behavior; with a "drug use" subscale measuring 0 - 30 (with lower scores representing better health outcomes related to drug use and higher scores representing poorer health outcomes related to drug use) and a "sexual behavior" subscale measuring 0 - 25 (with lower scores representing better health outcomes related to sexual behavior and higher scores representing poorer health outcomes related to sexual behavior). Both are summed to create a total score ranging from 0 - 55 (with lower totals representing better health outcomes related to HIV risk and higher totals representing poorer health outcomes related to HIV risk)

Full Information

First Posted
November 21, 2017
Last Updated
July 10, 2023
Sponsor
Washington State University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT03481049
Brief Title
Individualizing Incentives for Alcohol in the Severely Mentally Ill
Official Title
Novel EtG-Based Contingency Management for Alcohol in the Severely Mentally Ill
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 5, 2018 (Actual)
Primary Completion Date
November 3, 2023 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington State University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The investigators will evaluate the efficacy of a 2 various contingency management (CM) interventions (High-Magnitude CM, Shaping CM) for treating heavy drinking among individuals with serious mental illness and alcohol dependence who are seen within the context of a community mental health center setting. Participants will be 400 adults diagnosed with serious mental illness and alcohol dependence and those who demonstrate heavy drinking during the first 4 weeks will be randomized to receive treatment conditions.
Detailed Description
The objective of this study is to determine whether modifications to a CM intervention improve outcomes and reduce costs in heavy drinkers with serious mental illness using alcohol biomarker ethyl glucuronide (EtG) to test of alcohol abstinence. In CM, patients receive tangible rewards for demonstrating drug abstinence. The investigators propose to examine whether 2 strategies - 1. Increasing reinforcer magnitude (High-Magnitude CM) or 2. Reinforcing light drinking before reinforcing abstinence (Shaping CM) - can improve outcomes in heavy drinkers with serious mental illness. The investigators will compare the efficacy of these 2 approaches to Usual CM in heavy drinkers with serious mental illness. A total of 400 participants receiving treatment as usual at 2 treatment agencies will take part in a 4-week induction period. Participants (n=240) who attain a mean EtG > 349 ng/mL (heavy drinking) during the induction period will be randomized to either a) 4 months of standard-magnitude CM for submitting alcohol-abstinent EtG samples (EtG < 150 ng/mL) (Usual CM), b) 4 months of high-magnitude CM for submitting alcohol-abstinent EtG samples (High-Magnitude CM), or c) 1 month of CM for submitting alcohol samples that indicate light drinking (EtG < 500 ng/mL), followed by 3 months of CM for submitting alcohol-abstinent EtG samples (Shaping CM). The primary outcome will be EtG-verified alcohol abstinence during the last 3 months of treatment (when all reinforcement is contingent on abstinence) and during 12 months of follow-up. The investigators will also examine group differences in secondary outcomes, conduct a comprehensive economic analysis, and determine whether variables that make up the NIAAA Addictions Neuroclinical Assessment (ANA) model moderate alcohol abstinence.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Bipolar Disorder, Major Depressive Disorder, Alcohol Dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual CM
Arm Type
Experimental
Arm Description
Participants will earn at least 3 prize draws each time they submit an alcohol negative urine samples during weeks 5-20, plus treatment as usual
Arm Title
High-Magnitude CM
Arm Type
Experimental
Arm Description
Participants will earn twice as many prize draws than those in the Usual CM for alcohol abstinence during weeks 5-20, plus treatment as usual.
Arm Title
Shaping CM
Arm Type
Experimental
Arm Description
Participants will earn prize draws for light drinking during weeks 5-8 instead of alcohol abstinence and will then earn prize draws for abstinence during weeks 9-20, plus treatment as usual.
Intervention Type
Behavioral
Intervention Name(s)
Usual CM
Intervention Description
Behavioral reinforcement for alcohol abstinence
Intervention Type
Behavioral
Intervention Name(s)
High-Magnitude CM
Intervention Description
Behavioral reinforcement for alcohol abstinence
Intervention Type
Behavioral
Intervention Name(s)
Shaping CM
Intervention Description
Behavioral reinforcement for alcohol abstinence
Primary Outcome Measure Information:
Title
Alcohol use assessed by ethyl glucuronide (EtG) detection in urine
Description
Mean EtG value (in ng/mL). EtG <150 ng/mL = EtG-negative, EtG >149 ng/mL = EtG-positive, EtG <500 ng/mL = light drinking, EtG >499 ng/mL = heavy drinking
Time Frame
Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure)
Secondary Outcome Measure Information:
Title
Positive and Negative Syndrome Scale
Description
Psychiatric symptomology
Time Frame
At baseline, week 4, 8, 12, 16 through study completion
Title
Urinanalysis for Drug Use
Description
Urine tests for drug use
Time Frame
Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure)
Title
Addiction Severity Index (ASI)
Description
Alcohol and drug addiction severity
Time Frame
Baseline, week 4, 8, 12, 16 through study completion
Title
Alcohol and Cigarette Timeline Followback
Description
Alcohol and Cigarette Use
Time Frame
Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure)
Title
Fagerstrom Test of Nicotine Dependence
Description
Presence and severity of nicotine dependence
Time Frame
Baseline, week 4, 8, 12, 16 through study completion
Title
Housing Timeline FollowBack
Description
Assess homelessness
Time Frame
Baseline, during 4-week induction period, 16 weeks of treatment (repeated measure) through study completion
Title
Brief HIV Risk Behavior Scale
Description
HIV risk behavior; with a "drug use" subscale measuring 0 - 30 (with lower scores representing better health outcomes related to drug use and higher scores representing poorer health outcomes related to drug use) and a "sexual behavior" subscale measuring 0 - 25 (with lower scores representing better health outcomes related to sexual behavior and higher scores representing poorer health outcomes related to sexual behavior). Both are summed to create a total score ranging from 0 - 55 (with lower totals representing better health outcomes related to HIV risk and higher totals representing poorer health outcomes related to HIV risk)
Time Frame
Baseline, during 4-week induction period, 16 weeks of treatment (repeated measure) through study completion
Other Pre-specified Outcome Measures:
Title
NIH Toolbox Emotion battery
Description
Negative emotionality
Time Frame
Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure) through study completion
Title
NIH Toolbox Cognition battery
Description
Executive functioning
Time Frame
Baseline, weeks 20, 47, 71
Title
Obsessive-Compulsive Drinking Scale
Description
Self-report measure of frequency and consequences alcohol-related thoughts and behaviors; Obsessive subscale ranges from 0 - 20 (with lower score representing better health outcomes and higher scores representing poorer health outcomes) Compulsive subscale ranges from 0 -20 (with lower scores representing better health outcomes and higher scores representing poorer health outcomes). Total score (Obsessive + Compulsive sub scales ) ranging from 0 - 40 (with lower totals representing better health outcomes and higher totals representing poorer health outcomes).
Time Frame
Baseline, 16 weeks of treatment (repeated measure) through study completion
Title
Stimulus-Response Compatibility Task
Description
Cognitive measure of approach-avoidance of alcohol-related cues
Time Frame
Baseline, weeks 20, 47, 71
Title
Stages of Change Readiness and Treatment Eagerness Scale
Description
Motivation to change alcohol use; total scores range from 19 - 95 (with lower totals representing lesser readiness/eagerness for change and higher totals representing greater readiness/eagerness to change)
Time Frame
Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure) through study completion
Title
Treatment Experiences and Expediencies Questionnaire
Description
Assess drinking goals
Time Frame
Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure) through study completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Aged 18 to 65 years. 4 or more standard drinks for females (AFAB)/ 5 or more standard drinks for males (AMAB) on 5 or more occasions in the past 30 days. DSM-5 diagnosis of moderate to severe alcohol use disorder. DSM-5 diagnosis of schizophrenia or schizoaffective disorder, bipolar I or II, or recurrent major depressive disorder (>1 episode). Exclusion Criteria: Current DSM-5 diagnosis of a severe substance use disorder for any substances used within the past 30 days A significant risk of medically dangerous alcohol withdrawal (e.g. a history of seizures in the last 12 months, participant or clinician concern that abstinence will induce dangerous alcohol withdrawal). Any medical/psychiatric condition, or severity of that condition, that in the opinion of the PI, would compromise safe study participation. Inability to provide informed consent as measured by the MacCAT-CR. (e.g. dementia) Pregnant or planning to become pregnant.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael G McDonell, PhD
Organizational Affiliation
Washington State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sound Health
City
Seattle
State/Province
Washington
ZIP/Postal Code
98014
Country
United States
Facility Name
WSU Research Clinic
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Individualizing Incentives for Alcohol in the Severely Mentally Ill

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