Individualizing Incentives for Alcohol in the Severely Mentally Ill

  • STATUS
    Recruiting
  • End date
    Aug 31, 2024
  • participants needed
    400
  • sponsor
    Washington State University
Updated on 5 June 2022
heavy drinking
bipolar disorder
depressive disorder
psychiatric disorder
schizophrenia
alcoholism
alcohol use disorder
major depressive disorder
major depressive episode
schizoaffective disorder
Accepts healthy volunteers

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.

Details
Condition Schizophrenia, Bipolar Disorder, Major Depressive Disorder, Alcohol Dependence
Treatment Usual CM, High-Magnitude CM, Shaping CM
Clinical Study IdentifierNCT03481049
SponsorWashington State University
Last Modified on5 June 2022

Eligibility

Yes No Not Sure

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
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