N/A
Completed N=392
Individualizing Incentives for Alcohol in the Severely Mentally Ill
Source: ClinicalTrials.gov NCT03481049 ↗Enrolled (actual)
392
Serious AEs
4.0%
Results posted
Aug 2025
Primary outcomePrimary: Alcohol Use Assessed by Ethyl Glucuronide (EtG) Detection in Urine — 0.66; 0.65; 0.61 proportion uEtG negative
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Alcohol Use Assessed by Ethyl Glucuronide (EtG) Detection in Urine |
0.66; 0.65; 0.61 | — |
| SECONDARY Positive and Negative Syndrome Scale |
— | — |
| SECONDARY Urinanalysis for Drug Use |
— | — |
| SECONDARY Addiction Severity Index (ASI) |
— | — |
| SECONDARY Alcohol and Cigarette Timeline Followback |
— | — |
| SECONDARY Fagerstrom Test of Nicotine Dependence |
— | — |
| SECONDARY Housing Timeline FollowBack |
— | — |
| SECONDARY Brief HIV Risk Behavior Scale |
— | — |
| SECONDARY NIH Toolbox Emotion Battery |
— | — |
| SECONDARY NIH Toolbox Cognition Battery |
— | — |
| SECONDARY Obsessive-Compulsive Drinking Scale |
— | — |
| SECONDARY Stimulus-Response Compatibility Task |
— | — |
| SECONDARY Stages of Change Readiness and Treatment Eagerness Scale |
— | — |
| SECONDARY Treatment Experiences and Expediencies Questionnaire |
— | — |
Eligibility Criteria
Inclusion Criteria
- Aged 18 to 65 years.
- 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.
- 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).
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03481049). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.