Individualizing Incentives for Alcohol in the Severely Mentally Ill

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03481049
• Other study ID #: 16326
• Secondary ID: R01AA022070
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 5, 2018
• Est. completion date: August 31, 2024

Study information

• Verified date: April 2024
• Source: Washington State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: August 31, 2024
• Est. primary completion date: November 3, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism
• Bipolar Disorder
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder
• Schizophrenia

Intervention

Behavioral:
• Usual CM
Behavioral reinforcement for alcohol abstinence
• High-Magnitude CM
Behavioral reinforcement for alcohol abstinence
• Shaping CM
Behavioral reinforcement for alcohol abstinence

Locations

Country	Name	City	State
United States	Sound Health	Seattle	Washington
United States	WSU Research Clinic	Spokane	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Washington State University	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	NIH Toolbox Emotion battery	Negative emotionality	Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure) through study completion
Other	NIH Toolbox Cognition battery	Executive functioning	Baseline, weeks 20, 47, 71
Other	Obsessive-Compulsive Drinking Scale	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).	Baseline, 16 weeks of treatment (repeated measure) through study completion
Other	Stimulus-Response Compatibility Task	Cognitive measure of approach-avoidance of alcohol-related cues	Baseline, weeks 20, 47, 71
Other	Stages of Change Readiness and Treatment Eagerness Scale	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)	Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure) through study completion
Other	Treatment Experiences and Expediencies Questionnaire	Assess drinking goals	Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure) through study completion
Primary	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	Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure)
Secondary	Positive and Negative Syndrome Scale	Psychiatric symptomology	At baseline, week 4, 8, 12, 16 through study completion
Secondary	Urinanalysis for Drug Use	Urine tests for drug use	Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure)
Secondary	Addiction Severity Index (ASI)	Alcohol and drug addiction severity	Baseline, week 4, 8, 12, 16 through study completion
Secondary	Alcohol and Cigarette Timeline Followback	Alcohol and Cigarette Use	Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure)
Secondary	Fagerstrom Test of Nicotine Dependence	Presence and severity of nicotine dependence	Baseline, week 4, 8, 12, 16 through study completion
Secondary	Housing Timeline FollowBack	Assess homelessness	Baseline, during 4-week induction period, 16 weeks of treatment (repeated measure) through study completion
Secondary	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)	Baseline, during 4-week induction period, 16 weeks of treatment (repeated measure) through study completion