Usual CM
BehavioralBehavioral reinforcement for alcohol abstinence
NCT Number: NCT03481049
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.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Sound Health, Seattle, Washington, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Behavioral reinforcement for alcohol abstinence
Behavioral reinforcement for alcohol abstinence
Behavioral reinforcement for alcohol abstinence
Time frame: During weeks 5 -16 of treatment
Proportion of uEtG negative samples during weeks 5-16 of treatment. (EtG <150 ng/mL = EtG-negative)
Time frame: At baseline, week 4, 8, 12, 16 through study completion
Psychiatric symptomology
Time frame: Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure)
Urine tests for drug use
Time frame: Baseline, week 4, 8, 12, 16 through study completion
Alcohol and drug addiction severity
Time frame: Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure)
Alcohol and Cigarette Use
Time frame: Baseline, week 4, 8, 12, 16 through study completion
Presence and severity of nicotine dependence
Time frame: Baseline, during 4-week induction period, 16 weeks of treatment (repeated measure) through study completion
Assess homelessness
Time frame: Baseline, during 4-week induction period, 16 weeks of treatment (repeated measure) through study completion
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 and 16 weeks of treatment (repeated measure) through study completion
Negative emotionality
Time frame: Baseline, weeks 20, 47, 71
Executive functioning
Time frame: Baseline, 16 weeks of treatment (repeated measure) through study completion
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, weeks 20, 47, 71
Cognitive measure of approach-avoidance of alcohol-related cues
Time frame: Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure) through study completion
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
Assess drinking goals
Washington State University
Other
Novel EtG-Based Contingency Management for Alcohol in the Severely Mentally Ill
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