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Individualizing Incentives for Alcohol in the Severely Mentally Ill
NA trial testing Usual CM in Schizophrenia in 392 participants. Completed in 22 November 2024.
| Lead sponsor | Washington State University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 392 |
| Start date | 5 May 2018 |
| Primary completion | 3 June 2024 |
| Estimated completion | 22 November 2024 |
| Sites | 2 locations across United States |
Washington State University
Adults 18 to 65, any sex, with Schizophrenia or Bipolar Disorder. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Proportion of uEtG negative samples during weeks 5-16 of treatment. (EtG \<150 ng/mL = EtG-negative)
| Group | Value | 95% CI |
|---|---|---|
| Usual CM | 0.66 | ± 0.25 |
| High-Magnitude CM | 0.65 | ± 0.26 |
| Shaping CM | 0.61 | ± 0.28 |
Time frame: Adverse Event data was collected from the date the participant enrolled in the study (i.e. baseline), through the 1 month induction phase, the 4 month treatment phase, and the 1 year follow-up phase. Therefore, adverse event data was collected for 17 months for each study participant.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Usual CM | High-Magnitude CM | Shaping CM | Not Randomized |
|---|---|---|---|---|---|
| Inpatient Medical Treatment | General disorders | — | — | — | — |
| Suicide Attempt Resulting In Hospitalization | Psychiatric disorders | — | — | — | — |
| Alcohol Withdrawals that lead to hospitalization | Nervous system disorders | — | — | — | — |
| Reaction | System | Usual CM | High-Magnitude CM | Shaping CM | Not Randomized |
|---|---|---|---|---|---|
| Suicidal Ideation | Psychiatric disorders | — | — | — | — |
| ER Visit | General disorders | — | — | — | — |
| Inpatient Psychiatric Treatment | Psychiatric disorders | — | — | — | — |
| SHOT Score >/= 3 | Nervous system disorders | — | — | — | — |
| Alcohol related ER Visit | Psychiatric disorders | — | — | — | — |
| Inpatient Substance Abuse Treatment | Psychiatric disorders | — | — | — | — |
| Jail | Social circumstances | — | — | — | — |
| Suicide attempt (not hospitalization) | Psychiatric disorders | — | — | — | — |
| Other | Injury, poisoning and procedural complications | — | — | — | — |
Most-reported serious reactions: Inpatient Medical Treatment, Suicide Attempt Resulting In Hospitalization, Alcohol Withdrawals that lead to hospitalization.
Data from ClinicalTrials.gov NCT03481049 adverse events section.
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.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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