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Contingency Management for Alcoholism in Severe Mental Illness

N/A

Waitlist Available

Led By Michael G McDonell, PhD

Research Sponsored by Washington State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

DSM-5 diagnosis of schizophrenia or schizoaffective disorder, bipolar I or II, or recurrent major depressive disorder (>1 episode)

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 4, 8, 12, 16 through study completion

Awards & highlights

Study Summary

This trial will study whether two different approaches to contingency management (CM) can help reduce heavy drinking among people with serious mental illness and alcohol dependence who are seen at community mental health centers.

Who is the study for?

This trial is for adults aged 18-65 with serious mental illness and alcohol dependence, who drink heavily. It's open to those diagnosed with schizophrenia, schizoaffective disorder, bipolar I or II, or recurrent major depressive disorder. Pregnant individuals or those at risk of severe alcohol withdrawal symptoms are excluded.Check my eligibility

What is being tested?

The study tests two contingency management (CM) interventions—High-Magnitude CM and Shaping CM—to treat heavy drinking in the severely mentally ill within a community health setting. Participants will be randomly assigned to one of these treatment conditions.See study design

What are the potential side effects?

While specific side effects are not listed for the CM interventions being tested, participants may experience stress or anxiety due to changes in their routine or as a reaction to the therapy process.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with schizophrenia, schizoaffective disorder, bipolar disorder, or recurrent major depression.

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I have had 4+/5+ drinks on 5+ days in the last month.

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I am between 18 and 65 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 4, 8, 12, 16 through study completion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 4, 8, 12, 16 through study completion

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 4, 8, 12, 16 through study completion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Alcohol Use Disorder

Secondary outcome measures

Addiction Severity Index (ASI)

Alcohol and Cigarette Timeline Followback

Brief HIV Risk Behavior Scale

+4 more

Other outcome measures

NIH Toolbox Cognition battery

NIH Toolbox Emotion battery

Obsessive-Compulsive Drinking Scale

+3 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Usual CMExperimental Treatment1 Intervention

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

Group II: Shaping CMExperimental Treatment1 Intervention

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.

Group III: High-Magnitude CMExperimental Treatment1 Intervention

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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Washington State UniversityLead Sponsor

101 Previous Clinical Trials

56,314 Total Patients Enrolled

7 Trials studying Alcoholism

1,091 Patients Enrolled for Alcoholism

National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH

799 Previous Clinical Trials

1,362,111 Total Patients Enrolled

422 Trials studying Alcoholism

984,808 Patients Enrolled for Alcoholism

Michael G McDonell, PhDPrincipal InvestigatorWashington State University

1 Previous Clinical Trials

17 Total Patients Enrolled

1 Trials studying Alcoholism

17 Patients Enrolled for Alcoholism

Media Library

High-Magnitude CM Clinical Trial Eligibility Overview. Trial Name: NCT03481049 — N/A

Alcoholism Research Study Groups: Usual CM, High-Magnitude CM, Shaping CM

Alcoholism Clinical Trial 2023: High-Magnitude CM Highlights & Side Effects. Trial Name: NCT03481049 — N/A

High-Magnitude CM 2023 Treatment Timeline for Medical Study. Trial Name: NCT03481049 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria must prospective participants fulfill to be accepted into this trial?

"In order to be eligible for this clinical research, participants must have manic disorder and fall into the age range of 18-65. A total of 400 individuals are being recruited for participation."

Answered by AI

Does the enrollment criteria for this trial include persons of advanced age?

"Participation in this research project is open to individuals aged 18-65."

Answered by AI

Is participation in this experiment an option for current patients?

"Affirmative. Clinicaltrials.gov reveals that this medical trial, which debuted on May 5th 2018, is currently recruiting participants from 3 different sites with a goal of 400 enrollees."

Answered by AI

What is the aggregate number of individuals participating in this medical experiment?

"Correct. The clinical trial is actively recruiting, as evidenced by the records on clinicaltrials.gov that date back to May 5th 2018 and have been recently updated on May 17th 2022. This study requires 400 participants from 3 sites in total."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Individualizing Incentives for Alcohol in the Severely Mentally Ill

Michael McDonell 2018. "Individualizing Incentives for Alcohol in the Severely Mentally Ill". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03481049.

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