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| ID | Type | Description | Link |
|---|---|---|---|
| R21AA027045-01A1 | 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 contingency management (CM) in reducing alcohol use in individuals experiencing unstable housing but who are currently housed in shelters. Participants will be 20-30 adults diagnosed with alcohol use disorder (AUD) and has a history or unstable housing or literal homelessness in the last year but is currently receiving housing through Catholic Charities Spokane or other locations. Individuals who demonstrate AUD and have measurable PEth >ng/mL at the baseline visit will be randomized to receive Phosphatidylethanol-based CM treatment or non-contigent treatment.
The objective of this study is to determine whether CM intervention improves outcomes in the unstably housed population using alcohol biomarker phosphatidylethanol (PEth) and ethyl glucuronide (EtG) to test alcohol abstinence. In CM, participants receive tangible rewards for demonstrating drug abstinence while non-contingent intervention receive the rewards regardless of PEth and EtG results for alcohol.
The investigators propose to examine whether CM intervention, to reduce alcohol use to abstinence, is a feasible and acceptable treatment in supported housing. Additionally, this study will assess group differences (between PEth-based CM and non-contingent control) in alcohol abstinence, as assessed by PEth, EtG, and self-report. Characterization of group differences in housing status and other alcohol associated harms (e.g., physical and mental health, medical care, and incarceration) will also be analyzed.
A total of 20-30 participants receiving treatment as usual through Catholic Charities Spokane or other locations in the Pacific and Mountain Time Zones will take part. Participants with AUD and have PEth biomarker results above >20 ng/mL, which indicates regular alcohol usage will be randomized to
The investigators will also be examining group differences in secondary outcomes including self-reported abstinence and heavy drinking assessed by the alcohol timeline follow back and urine EtG analyses. Other secondary outcomes include a) Addiction Severity Index Lite which assesses impact of alcohol us on psychiatric, legal, medical and family functioning, b) self-reported drug use and its severity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEth-based CM | Experimental | PEth-based CM participants will receive gift cards (starting at $30) each time they submit a blood spot sample (via finger prick ) with a negative alcohol result. They will receive an additional $5 (building on the previous amount) for each additional negative alcohol result in a row. There is a cap at $100 for each negative result. |
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| Non-contingent Control | Active Comparator | Non-contingent control participants will receive gift cards each visit if they provide a pinprick blood sample regardless of whether the results are positive or negative for alcohol. Their level of reinforcement (amount in gift cards) will be equal to the average weekly CM earnings from the previous month. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phosphatidylethanol-based Contingency Management | Behavioral | In CM, tangible reinforcers are provided after individuals demonstrate biochemically verified abstinence of various substances. CM is associated with increased abstinence from illicit drugs, nicotine, and alcohol and is the most powerful psychosocial treatment for initiating abstinence of these substances. When participants submit a negative result for alcohol (via blood phosphatidylethanol biomarkers), the subject will receive rewards (gift cards). In contrast, they will not receive rewards when their samples test positive for alcohol. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Attrition to measure acceptability of PEth-based CM Intervention | Tolerability of PEth-based CM procedures (pinprick blood sample) measured by attendance, or attrition, with CM noted as acceptable if attrition is less than or equal to 30%. Attrition will be defined as 1 month of no contact with study team. | 26 weeks of treatment (repeated measure) through study completion |
| Acceptability of PEth-based CM: Client Satisfaction Questionnaire-8 | Administration of Client Satisfaction Questionnaire-8, a brief measure of client satisfaction that has been validated in addiction treatment. The scale ranges from 1 to 4 with 4 indicating higher satisfaction. Total scores therefore range from 8 (least satisfaction) to 32 (highest satisfaction). | Weeks 4, 8, 12, 16, 20, and 26; repeated measure to assess change in satisfaction through study completion |
| Qualitative interviews to assess satisfaction, feasibility and acceptability of PEth-based CM Intervention using Theory Domains Framework (TDF) | Assessed by TDF to encode interviews to provide comprehensive, theory-informed data to identify determinants of satisfaction, feasibility and acceptability of intervention | Weeks 4, 12, and 26; repeated measure to assess change in satisfaction, feasibility, and tolerability through study completion |
| Incidence of alcohol abstinence assessed by PEth biomarker | Efficacy of PEth-based CM in reduction of alcohol consumption to abstinence assessed by measurement of PEth in blood samples. PEth biomarker assessed at 16:0/18:1 for 7 days or < 20 ng/ml which is consistent with 14-28 days of abstinence | Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, and 26; repeated measure to assess change through study completion |
| Efficacy of PEth-based CM in Stabilization of Housing Status |
| Measure | Description | Time Frame |
|---|---|---|
| Self-Reported Alcohol Usage | Days self-reported abstinence, drinking or heavy drinking measured by the Alcohol Timeline Follow Back | 26 weeks of treatment (repeated measure) through study completion |
| Alcohol Usage as measured by Urine Ethyl Glucuronide (uEtG) |
| Measure | Description | Time Frame |
|---|---|---|
| Short-Form Health Survey-12 | Measures mental and physical functioning and overall health-related quality of life. The scale for health includes: poor, fair, good, very good, and excellent. The pain interference scale includes: not at all, a little bit, moderately, quite a bit, and extremely. | Weeks 4, 8, 12, 16, 20, and 26 (repeated measure) through study completion |
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 |
|---|---|---|---|---|---|---|
| Catholic Charities of Eastern Washington | Spokane | Washington | 99202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38284925 | Derived | Jett JD, Beck R, Tyutyunnyk D, Sanchez J, Weeks DL, Javors MA, Hill-Kapturczak N, Lopez-Cruzan M, Kriegel L, Ginsburg BC, Cabassa L, McDonell MG. Feasibility of a telehealth-based contingency management intervention for alcohol use disorders using the phosphatidylethanol (PEth) 16:0/18:1 alcohol biomarker: a pilot randomized trial. Am J Drug Alcohol Abuse. 2024 Mar 3;50(2):162-172. doi: 10.1080/00952990.2023.2283691. Epub 2024 Jan 29. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 22, 2024 | |
| Reset | Jun 17, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 22, 2024 | Jun 17, 2024 |
| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| Non-Contingent Control | Behavioral | In the non-contingent control intervention, participants will receive rewards (gift cards) regardless of the alcohol biomarker results in their samples. Once the samples have been received, the subjects will receive reinforcers that is consistent with the average from the CM group's earnings. |
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Measured by self-report of housing status using the Residential Timeline Follow Back; includes number of days stably housed, temporarily housed, institutionally housed or literally homeless. Residential Timeline Follow Back classifies location description of housing into literal homelessness, institutional housing, temporary housing, or stable housing.
| Weeks 1, 4, 8, 12, 16, 20, and 26; repeated measure to assess change of housing through study completion |
uEtG collected and measured to determine alcohol usage in last 1-4 days; uEtG greater or equal to 300 ng/ml is identified as recent drinking occurrence |
| 26 weeks of treatment (repeated measure) through study completion |
| The Addiction Severity Index Lite | Assesses alcohol use on psychiatry, legal, medical, and family functioning, as well as self-reported drug use and its severity. Scale ranges from 0 (no craving at all) to 4 (extreme cravings) | Weeks 1, 4, 8, 12, 16, 20, and 26 (repeated measure) through study completion |
| Non-Study Resource Form for Medical and Criminal Justice Utilization | Measures outpatient addiction, mental health, primary care, and vocational services, as well as the emergency department, inpatient psychiatric, and medical hospitalizations, detox admissions, residential addiction treatment, arrests and incarcerations. | Weeks 4, 8, 12, 16, 20, and 26 through study completion |
| Substance Use Test | Urine samples will be tested for opioids, amphetamine, methamphetamine, cocaine, and cannabis with E-Z split (type of urine analysis cup) point-of-care immunoassays | 26 weeks of treatment (repeated measure) through study completion |
| Cigarette Consumption | Assessed with the Cigarette Timeline Follow Back to measure smoking and other nicotine use | 26 weeks of treatment (repeated measure) through study completion |
| Cognitive Functioning | Using a battery of cognitive tests from Test My Brain | Week 1 and 26 (repeated measure) through study completion |
| Fagerstrom Test for Nicotine Dependence | Assesses an individual's dependence on nicotine; score total range from 0 to 10 with 0 being no dependence and 10 being most intense physical dependence on nicotine | 26 weeks of treatment (repeated measure) through study completion |
| Alcohol-Related Incentive Salience | Self-rating instrument that provides a total and two subscale scores that measure some cognitive aspects of alcohol cravings | Weeks 1, 4, 8, 12, 16, 20, and 26 (repeated measure) through study completion |
| Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES) | 19-item scale measuring an individual's eagerness to change drinking habits; each item has a score of 1 (strongly disagree) , 2 (disagree), 3 (not sure/undecided), 4 (agree), and 5 (strongly agree). There are three sub-scales for recognition, ambivalence, and taking steps in relation to drinking. The higher the score for each sub-scale indicate acknowledgement of drinking problem, uncertainty of control over drinking, and changing habits around drinking, respectively. Lower scores indicate denial of alcohol being a problem, not wondering about control of drinking, and not taking steps to change drinking, respectively. | Weeks 1, 4, 8, 12, 16, 20, and 26 (repeated measure) through study completion |
| Rate of Adverse Events | Risks related to suicidality, dangerous alcohol use and withdrawal symptoms will be assessed | 26 weeks of treatment (repeated measure) through study completion |
| Emotional Functioning - Depression | A questionnaire measuring the severity of depression (PHQ-9). PQQ-9 is scored on a 4 point scale: 1 (not at all), 2 (several days), 3 (more than half the days), and 4 (nearly every day). | Weeks 1, 4, 8, 12, 16, 20, and 26 (repeated measure) through study completion |
| Emotional Functioning - Anxiety | A questionnaire measuring the severity of anxiety (GAD-7). GAD-7 is scored on a 4 point scale: 1 (not at all), 2 (several days), 3 (more than half the days), and 4 (nearly every day). | Weeks 1, 4, 8, 12, 16, 20, and 26 (repeated measure) through study completion |
| Emotional Functioning - Stress | A questionnaire measuring the severity of stress (PSS). The PSS is scored on a 5 point scale: 0 (Never), 1 (Almost Never), 2 (Sometimes), 3 (Fairly Often), 4 (Very Often) | Weeks 1, 4, 8, 12, 16, 20, and 26 (repeated measure) through study completion |