SchizophreniaNCT03481049
Individualizing Incentives for Alcohol in the Severely Mentally Ill
A study testing Usual CM, High-Magnitude CM and Shaping CM in people with Schizophrenia and Bipolar Disorder, run by Washington State University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Bipolar Disorder, Major Depressive Disorder
- What is being tested?
- Usual CM, High-Magnitude CM and Shaping CM
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 392 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 May 2018to 22 Nov 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Sound Health
Seattle, Washington, 98014
WSU Research Clinic
Spokane, Washington, 99202
About this study
Official title: Novel EtG-Based Contingency Management for Alcohol in the Severely Mentally Ill
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.
Read the detailed description
The objective of this study is to determine whether modifications to a CM intervention improve outcomes and reduce costs in heavy drinkers with serious mental illness using alcohol biomarker ethyl glucuronide (EtG) to test of alcohol abstinence. In CM, patients receive tangible rewards for demonstrating drug abstinence.
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.
- Being tested
- Usual CM, High-Magnitude CM, Shaping CM
- Medical subject headings
- Schizophrenia, Bipolar Disorder, Depressive Disorder, Major, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual CMBehavioural
Behavioral reinforcement for alcohol abstinence
High-Magnitude CMBehavioural
Behavioral reinforcement for alcohol abstinence
Shaping CMBehavioural
Behavioral reinforcement for alcohol abstinence
| Study group | Role | What they receive |
|---|---|---|
| Usual CM | Experimental | 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 Receives: Behavioral: Usual CM |
| High-Magnitude CM | Experimental | 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. Receives: Behavioral: High-Magnitude CM |
| Shaping CM | Experimental | 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. Receives: Behavioral: Shaping CM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: During weeks 5 -16 of treatment
Secondary outcomes (13)
Positive and Negative Syndrome Scale
Psychiatric symptomology
Measured: At baseline, week 4, 8, 12, 16 through study completion
Urinanalysis for Drug Use
Urine tests for drug use
Measured: Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure)
Addiction Severity Index (ASI)
Alcohol and drug addiction severity
Measured: Baseline, week 4, 8, 12, 16 through study completion
Alcohol and Cigarette Timeline Followback
Alcohol and Cigarette Use
Measured: Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure)
Fagerstrom Test of Nicotine Dependence
Presence and severity of nicotine dependence
Measured: Baseline, week 4, 8, 12, 16 through study completion
Housing Timeline FollowBack
Assess homelessness
Measured: Baseline, during 4-week induction period, 16 weeks of treatment (repeated measure) through study completion
Brief HIV Risk Behavior Scale
HIV risk behavior; with a "drug use" subscale measuring 0 - 30 (with lower scores representing better health outcomes related to drug use and higher scores representing poorer health outcomes related to drug use) and a "sexual behavior" subscale measuring 0 - 25 (with lower scores representing better health outcomes related to sexual behavior and higher scores representing poorer health outcomes related to sexual behavior). Both are summed to create a total score ranging from 0 - 55 (with lower totals representing better health outcomes related to HIV risk and higher totals representing poorer health outcomes related to HIV risk)
Measured: Baseline, during 4-week induction period, 16 weeks of treatment (repeated measure) through study completion
NIH Toolbox Emotion Battery
Negative emotionality
Measured: Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure) through study completion
NIH Toolbox Cognition Battery
Executive functioning
Measured: Baseline, weeks 20, 47, 71
Obsessive-Compulsive Drinking Scale
Self-report measure of frequency and consequences alcohol-related thoughts and behaviors; Obsessive subscale ranges from 0 - 20 (with lower score representing better health outcomes and higher scores representing poorer health outcomes) Compulsive subscale ranges from 0 -20 (with lower scores representing better health outcomes and higher scores representing poorer health outcomes). Total score (Obsessive + Compulsive sub scales ) ranging from 0 - 40 (with lower totals representing better health outcomes and higher totals representing poorer health outcomes).
Measured: Baseline, 16 weeks of treatment (repeated measure) through study completion
Stimulus-Response Compatibility Task
Cognitive measure of approach-avoidance of alcohol-related cues
Measured: Baseline, weeks 20, 47, 71
Stages of Change Readiness and Treatment Eagerness Scale
Motivation to change alcohol use; total scores range from 19 - 95 (with lower totals representing lesser readiness/eagerness for change and higher totals representing greater readiness/eagerness to change)
Measured: Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure) through study completion
Treatment Experiences and Expediencies Questionnaire
Assess drinking goals
Measured: Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure) through study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start5 May 2018
- Primary completion3 Jun 2024
- Study completion22 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 392 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Michael McDonell, Washington State University
- Investigators
- Michael G McDonell, PhD, Principal investigator, Washington State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03481049
- Sponsor's protocol ID
- 16326
- Other IDs
- R01AA022070
- Status last verified
- Aug 2025
- First submitted
- 21 Nov 2017
- Last updated
- 11 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40569730
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel EtG-Based Contingency Management for Alcohol in the Severely Mentally Ill
- ClinicalTrials.gov ID
- NCT03481049
- Acronym / sponsor ID
- 16326
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 392 participants (actual)
- Lead sponsor
- Washington State UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 5 May 2018 (actual)
- Primary completion
- 3 Jun 2024 (actual)
- Study completion
- 22 Nov 2024 (actual)
- First posted
- 29 Mar 2018 (actual)
- Results
- Posted 11 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The objective of this study is to determine whether modifications to a CM intervention improve outcomes and reduce costs in heavy drinkers with serious mental illness using alcohol biomarker ethyl glucuronide (EtG) to test of alcohol abstinence. In CM, patients receive tangible rewards for demonstrating drug abstinence.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Usual CM | Experimental | Behavioral: Usual CMParticipants 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 | Experimental | Behavioral: High-Magnitude CMParticipants 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 | Experimental | Behavioral: Shaping CMParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual CMBehavioral reinforcement for alcohol abstinence | Behavioural | Usual CM |
| High-Magnitude CMBehavioral reinforcement for alcohol abstinence | Behavioural | High-Magnitude CM |
| Shaping CMBehavioral reinforcement for alcohol abstinence | Behavioural | Shaping CM |
Primary outcome
Alcohol Use Assessed by Ethyl Glucuronide (EtG) Detection in Urine
Time frame: During weeks 5 -16 of treatment
Proportion of uEtG negative samples during weeks 5-16 of treatment. (EtG <150 ng/mL = EtG-negative)
13 secondary outcomes
Positive and Negative Syndrome Scale
Time frame: At baseline, week 4, 8, 12, 16 through study completion
Urinanalysis for Drug Use
Time frame: Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure)
Addiction Severity Index (ASI)
Time frame: Baseline, week 4, 8, 12, 16 through study completion
Alcohol and Cigarette Timeline Followback
Time frame: Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure)
Fagerstrom Test of Nicotine Dependence
Time frame: Baseline, week 4, 8, 12, 16 through study completion
Housing Timeline FollowBack
Time frame: Baseline, during 4-week induction period, 16 weeks of treatment (repeated measure) through study completion
Brief HIV Risk Behavior Scale
Time frame: Baseline, during 4-week induction period, 16 weeks of treatment (repeated measure) through study completion
NIH Toolbox Emotion Battery
Time frame: Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure) through study completion
NIH Toolbox Cognition Battery
Time frame: Baseline, weeks 20, 47, 71
Obsessive-Compulsive Drinking Scale
Time frame: Baseline, 16 weeks of treatment (repeated measure) through study completion
Stimulus-Response Compatibility Task
Time frame: Baseline, weeks 20, 47, 71
Stages of Change Readiness and Treatment Eagerness Scale
Time frame: Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure) through study completion
Treatment Experiences and Expediencies Questionnaire
Time frame: Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure) through study completion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40569730McDonell 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael G McDonell, PhD principal investigator
Washington State University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Usual CM, High-Magnitude CM and Shaping CM in people with Schizophrenia and Bipolar Disorder, run by Washington State University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol Use Assessed by Ethyl Glucuronide (EtG) Detection in Urine (time frame: During weeks 5 -16 of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03481049, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.