Individualizing Incentives for Alcohol in the Severely Mentally Ill
NCT ID: NCT03481049
Last Updated: 2025-08-11
Study Results
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View full resultsBasic Information
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COMPLETED
NA
392 participants
INTERVENTIONAL
2018-05-05
2024-11-22
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Usual CM
Participants will earn at least 3 prize draws each time they submit an alcohol negative urine samples during weeks 5-20, plus treatment as usual
Usual CM
Behavioral reinforcement for alcohol abstinence
High-Magnitude CM
Participants will earn twice as many prize draws than those in the Usual CM for alcohol abstinence during weeks 5-20, plus treatment as usual.
High-Magnitude CM
Behavioral reinforcement for alcohol abstinence
Shaping CM
Participants will earn prize draws for light drinking during weeks 5-8 instead of alcohol abstinence and will then earn prize draws for abstinence during weeks 9-20, plus treatment as usual.
Shaping CM
Behavioral reinforcement for alcohol abstinence
Interventions
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Usual CM
Behavioral reinforcement for alcohol abstinence
High-Magnitude CM
Behavioral reinforcement for alcohol abstinence
Shaping CM
Behavioral reinforcement for alcohol abstinence
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
65 Years
ALL
Yes
Sponsors
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National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIH
Washington State University
OTHER
Responsible Party
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Michael McDonell
Professor
Principal Investigators
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Michael G McDonell, PhD
Role: PRINCIPAL_INVESTIGATOR
Washington State University
Locations
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Sound Health
Seattle, Washington, United States
WSU Research Clinic
Spokane, Washington, United States
Countries
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References
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McDonell MG, Parent S, Jett JD, Keshtkar M, Palmer K, Beck R, Tyutyunnyk D, Williams M, Weeks DL, Chaytor NS, McPherson S, Murphy SM, Ries RK, Roll JM. Testing adaptations to contingency management for alcohol use disorders: A randomized controlled trial. J Consult Clin Psychol. 2025 Aug;93(8):540-550. doi: 10.1037/ccp0000960. Epub 2025 Jun 26.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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16326
Identifier Type: -
Identifier Source: org_study_id
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