Individualizing Incentives for Alcohol in the Severely Mentally Ill

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

Status
Recruiting

Start date
05/05/2018

Healthy
Accepts Healthy Volunteers

Contact

Morgan E Kelly, MA

206-566-3601

[email protected]

Conditions
AlcoholismSchizophreniaDepressive DisorderDepressive Disorder, MajorBipolar Disorder

Age
18 Years — 65 Years

Gender
All

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.

Overview
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.

Eligibility Criteria
Inclusion Criteria:

Currently receiving treatment psychiatric [AND intensive outpatient addiction treatment] at Sound Health or Frontier Behavioral Health.
Aged 18 to 65 years.
4 or more standard drinks 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.

Exclusion Criteria:

Current DSM-5 diagnosis of a severe substance use disorder.
A significant risk of dangerous alcohol withdrawal: a history of seizures in the last 12 months AND 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 University of California San Diego Brief Assessment of Capacity (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.

Frontier Behavioral Health

Spokane, Washington 99202 Recruiting

Tom Anderson

509-838-4651

[email protected]

Sound Health

Seattle, Washington 98014 Recruiting

David Newman

206-461-3614

[email protected]

Subscribe.

Stay up to date on our latest content and information on clinical trial research by subscribing to our newsletter.

Conditions

Select the conditions that you wish to learn more about.