Clinical trial NCT03481049: 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
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Bipolar Disorder
Major Depressive Disorder
Alcohol Dependence
Lead sponsor: Washington State University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2018-03-29
Enrollment: 392
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Alcohol use assessed by ethyl glucuronide (EtG) detection in urine
timeFrame: Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure)
Secondary outcomes:
measure: Positive and Negative Syndrome Scale
timeFrame: At baseline, week 4, 8, 12, 16 through study completion
measure: Urinanalysis for Drug Use
timeFrame: Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure)
measure: Addiction Severity Index (ASI)
timeFrame: Baseline, week 4, 8, 12, 16 through study completion
measure: Alcohol and Cigarette Timeline Followback
timeFrame: Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure)
measure: Fagerstrom Test of Nicotine Dependence
timeFrame: Baseline, week 4, 8, 12, 16 through study completion
measure: Housing Timeline FollowBack
timeFrame: Baseline, during 4-week induction period, 16 weeks of treatment (repeated measure) through study completion
measure: Brief HIV Risk Behavior Scale
timeFrame: Baseline, during 4-week induction period, 16 weeks of treatment (repeated measure) through study completion
Other outcomes:
measure: NIH Toolbox Emotion battery
timeFrame: Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure) through study completion
measure: NIH Toolbox Cognition battery
timeFrame: Baseline, weeks 20, 47, 71
measure: Obsessive-Compulsive Drinking Scale
timeFrame: Baseline, 16 weeks of treatment (repeated measure) through study completion
measure: Stimulus-Response Compatibility Task
timeFrame: Baseline, weeks 20, 47, 71
measure: Stages of Change Readiness and Treatment Eagerness Scale
timeFrame: Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure) through study completion
measure: Treatment Experiences and Expediencies Questionnaire
timeFrame: Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure) through study completion
Locations:
city: Seattle
country: United States
facility: Sound Health
state: Washington
city: Spokane
country: United States
facility: WSU Research Clinic
state: Washington
Study officials:
affiliation: Washington State University
name: Michael G McDonell, PhD
role: PRINCIPAL_INVESTIGATOR
References: