Individualizing Incentives for Alcohol in the Severely Mentally Ill
Novel EtG-Based Contingency Management for Alcohol in the Severely Mentally Ill
2 other identifiers
interventional
392
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable schizophrenia
Started May 2018
Longer than P75 for not_applicable schizophrenia
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 21, 2017
CompletedFirst Posted
Study publicly available on registry
March 29, 2018
CompletedStudy Start
First participant enrolled
May 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 3, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 22, 2024
CompletedResults Posted
Study results publicly available
August 11, 2025
CompletedAugust 11, 2025
August 1, 2025
6.1 years
November 21, 2017
May 23, 2025
August 8, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Alcohol Use Assessed by Ethyl Glucuronide (EtG) Detection in Urine
Proportion of uEtG negative samples during weeks 5-16 of treatment. (EtG \<150 ng/mL = EtG-negative)
During weeks 5 -16 of treatment
Secondary Outcomes (13)
Positive and Negative Syndrome Scale
At baseline, week 4, 8, 12, 16 through study completion
Urinanalysis for Drug Use
Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure)
Addiction Severity Index (ASI)
Baseline, week 4, 8, 12, 16 through study completion
Alcohol and Cigarette Timeline Followback
Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure)
Fagerstrom Test of Nicotine Dependence
Baseline, week 4, 8, 12, 16 through study completion
- +8 more secondary outcomes
Study Arms (3)
Usual CM
EXPERIMENTALParticipants will earn at least 3 prize draws each time they submit an alcohol negative urine samples during weeks 5-20, plus treatment as usual
High-Magnitude CM
EXPERIMENTALParticipants will earn twice as many prize draws than those in the Usual CM for alcohol abstinence during weeks 5-20, plus treatment as usual.
Shaping CM
EXPERIMENTALParticipants 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.
Interventions
Eligibility Criteria
You may qualify if:
- Aged 18 to 65 years.
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Sound Health
Seattle, Washington, 98014, United States
WSU Research Clinic
Spokane, Washington, 99202, United States
Related Publications (1)
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.
PMID: 40569730DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Michael G. McDonell
- Organization
- Washington State University
Study Officials
- PRINCIPAL INVESTIGATOR
Michael G McDonell, PhD
Washington State University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 21, 2017
First Posted
March 29, 2018
Study Start
May 5, 2018
Primary Completion
June 3, 2024
Study Completion
November 22, 2024
Last Updated
August 11, 2025
Results First Posted
August 11, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share