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| ID | Type | Description | Link |
|---|---|---|---|
| R01AA022070 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Usual CM | Behavioral | Behavioral reinforcement for alcohol abstinence |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Positive and Negative Syndrome Scale | Psychiatric symptomology | At baseline, week 4, 8, 12, 16 through study completion |
| Urinanalysis for Drug Use | Urine tests for drug use |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael G McDonell, PhD | Washington State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sound Health | Seattle | Washington | 98014 | United States | ||
| WSU Research Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40569730 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual CM | Participants will earn at least 5 prize draws each time they submit an alcohol negative urine samples during weeks 5-20, plus treatment as usual Usual CM: Behavioral reinforcement for alcohol abstinence |
| FG001 | High-Magnitude CM | Participants will earn at least 15 prize draws for alcohol abstinence during weeks 5-20, plus treatment as usual. High-Magnitude CM: Behavioral reinforcement for alcohol abstinence |
| FG002 | Shaping CM | Participants will earn prize draws (at least 5) 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. Shaping CM: Behavioral reinforcement for alcohol abstinence |
| FG003 | Not Randomized | This is the group of participants who enrolled in the study but were not eligible for randomization. (Randomization criteria included an induction phase average uEtG >349 ng/mL and attendance in the last week of induction.) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual CM | 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 Usual CM: Behavioral reinforcement for alcohol abstinence |
| BG001 | High-Magnitude CM |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Posted | Mean | Standard Deviation | proportion uEtG negative | During weeks 5 -16 of treatment |
|
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.
The data safety monitoring plan included the standard definitions accepted by clinicaltrials.gov, with the following differences:
Because inpatient psychiatric or substance abuse treatment can be considered a worsening of a pre-existing condition with this study populations, these events were reported as Adverse Events, not Serious Adverse Events.
AEs/SAEs were assessed through regularly scheduled questionnaires and assessments.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual CM | Participants will earn at least 5 prize draws each time they submit an alcohol negative urine samples during weeks 5-20, plus treatment as usual Usual CM: Behavioral reinforcement for alcohol abstinence |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Inpatient Medical Treatment | General disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alcohol related ER Visit | Psychiatric disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael G. McDonell | Washington State University | 509-368-6967 | mmcdonell@wsu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 27, 2025 | Aug 5, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 6, 2023 | Aug 5, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D001714 | Bipolar Disorder |
| D003865 | Depressive Disorder, Major |
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
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| High-Magnitude CM |
| Behavioral |
Behavioral reinforcement for alcohol abstinence |
|
| Shaping CM | Behavioral | Behavioral reinforcement for alcohol abstinence |
|
| Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure) |
| Addiction Severity Index (ASI) | Alcohol and drug addiction severity | Baseline, week 4, 8, 12, 16 through study completion |
| Alcohol and Cigarette Timeline Followback | Alcohol and Cigarette Use | Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure) |
| Fagerstrom Test of Nicotine Dependence | Presence and severity of nicotine dependence | Baseline, week 4, 8, 12, 16 through study completion |
| Housing Timeline FollowBack | Assess homelessness | 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) | Baseline, during 4-week induction period, 16 weeks of treatment (repeated measure) through study completion |
| NIH Toolbox Emotion Battery | Negative emotionality | Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure) through study completion |
| NIH Toolbox Cognition Battery | Executive functioning | 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). | Baseline, 16 weeks of treatment (repeated measure) through study completion |
| Stimulus-Response Compatibility Task | Cognitive measure of approach-avoidance of alcohol-related cues | 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) | Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure) through study completion |
| Treatment Experiences and Expediencies Questionnaire | Assess drinking goals | Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure) through study completion |
| Spokane |
| Washington |
| 99202 |
| United States |
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. High-Magnitude CM: Behavioral reinforcement for alcohol abstinence |
| BG002 | Shaping CM | 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. Shaping CM: Behavioral reinforcement for alcohol abstinence |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG002 | Shaping CM | Participants will earn at least 5 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. Shaping CM: Behavioral reinforcement for alcohol abstinence. |
|
|
| Secondary | Positive and Negative Syndrome Scale | Psychiatric symptomology | Not Posted | At baseline, week 4, 8, 12, 16 through study completion | Participants |
| Secondary | Urinanalysis for Drug Use | Urine tests for drug use | Not Posted | Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure) | Participants |
| Secondary | Addiction Severity Index (ASI) | Alcohol and drug addiction severity | Not Posted | Baseline, week 4, 8, 12, 16 through study completion | Participants |
| Secondary | Alcohol and Cigarette Timeline Followback | Alcohol and Cigarette Use | Not Posted | Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure) | Participants |
| Secondary | Fagerstrom Test of Nicotine Dependence | Presence and severity of nicotine dependence | Not Posted | Baseline, week 4, 8, 12, 16 through study completion | Participants |
| Secondary | Housing Timeline FollowBack | Assess homelessness | Not Posted | Baseline, during 4-week induction period, 16 weeks of treatment (repeated measure) through study completion | Participants |
| Secondary | 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) | Not Posted | Baseline, during 4-week induction period, 16 weeks of treatment (repeated measure) through study completion | Participants |
| Secondary | NIH Toolbox Emotion Battery | Negative emotionality | Not Posted | Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure) through study completion | Participants |
| Secondary | NIH Toolbox Cognition Battery | Executive functioning | Not Posted | Baseline, weeks 20, 47, 71 | Participants |
| Secondary | 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). | Not Posted | Baseline, 16 weeks of treatment (repeated measure) through study completion | Participants |
| Secondary | Stimulus-Response Compatibility Task | Cognitive measure of approach-avoidance of alcohol-related cues | Not Posted | Baseline, weeks 20, 47, 71 | Participants |
| Secondary | 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) | Not Posted | Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure) through study completion | Participants |
| Secondary | Treatment Experiences and Expediencies Questionnaire | Assess drinking goals | Not Posted | Baseline, during 4-week induction period and 16 weeks of treatment (repeated measure) through study completion | Participants |
| 0 |
| 53 |
| 4 |
| 57 |
| 30 |
| 57 |
| EG001 | High-Magnitude CM | Participants will earn at least 15 prize draws for alcohol abstinence during weeks 5-20, plus treatment as usual. High-Magnitude CM: Behavioral reinforcement for alcohol abstinence | 0 | 54 | 3 | 55 | 21 | 55 |
| EG002 | Shaping CM | Participants will earn prize draws (at least 5) for light drinking during weeks 5-8 and will then earn prize draws for abstinence during weeks 9-20, plus treatment as usual. Shaping CM: Behavioral reinforcement for alcohol abstinence | 0 | 51 | 7 | 54 | 23 | 54 |
| EG003 | Not Randomized | Participants who enrolled in the study but were not eligible for randomization. (Eligibility for randomization included an average induction uEtG >349 ng/mL and attendance in last week of induction.) | 0 | 234 | 2 | 234 | 63 | 234 |
| Suicide Attempt Resulting In Hospitalization | Psychiatric disorders | Systematic Assessment |
|
| Alcohol Withdrawals that lead to hospitalization | Nervous system disorders | Systematic Assessment |
|
| ER Visit | General disorders | Systematic Assessment |
|
| Inpatient Psychiatric Treatment | Psychiatric disorders | Systematic Assessment |
|
| Inpatient Substance Abuse Treatment | Psychiatric disorders | Systematic Assessment |
|
| Jail | Social circumstances | Systematic Assessment |
|
| SHOT Score >/= 3 | Nervous system disorders | Systematic Assessment |
|
| Suicide attempt (not hospitalization) | Psychiatric disorders | Systematic Assessment |
|
| Suicidal Ideation | Psychiatric disorders | Systematic Assessment |
|
| Other | Injury, poisoning and procedural complications | Systematic Assessment | Injuries that were significant, but did not results in visit to emergency department |
|
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| D003866 | Depressive Disorder |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |