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Phosphatidylethanol-Based Contingency Management for Housing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04038021
Recruitment Status : Recruiting
First Posted : July 30, 2019
Last Update Posted : March 31, 2020
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Michael McDonell, Washington State University

Brief Summary:
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 50 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. Individuals who demonstrate AUD during the first 4 weeks will be randomized to receive Phosphatidylethanol-based CM treatment or non-contigent treatment.

Condition or disease Intervention/treatment Phase
Alcohol Use Disorder Behavioral: Phosphatidylethanol-based Contingency Management Behavioral: Non-Contingent Control Not Applicable

Detailed Description:

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 50 participants receiving treatment as usual through Catholic Charities Spokane will take part in a 4-week initiation phase. Participants who attend every visit in this initiation period and PEth biomarker indicates a decrease in alcohol usage will be randomized to a) 4 months of PEth-based CM for submitting alcohol-abstinent PEth results of 16:0/18:1 which is associated with abstinence in the past week, which is <20 ng/ml PEth biomarker in the blood when abstinent for 14-28 days. Urine EtG results will be analyzed to verify PEth result findings, b) 4 months of non-contingent control for submitting samples each week for the first 4 weeks then every 2 weeks for 8 weeks and then every 4 weeks until week 26. Control participants receive reinforcers regardless of the results of their PEth results. The primary outcomes will assess acceptability measured by attrition, Client Satisfaction Questionnaire-8 and qualitative interviews at weeks 4, 12, and 26. Other primary outcomes include assessment of effectiveness of PEth-based CM on reducing alcohol use to abstinence and housing status.

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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phosphatidylethanol-Based Contingency Management to Reduce Alcohol Use and Improve Housing Outcomes
Actual Study Start Date : January 13, 2020
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arm Intervention/treatment
Experimental: PEth-based CM
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.
Behavioral: Phosphatidylethanol-based Contingency Management
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.
Other Name: Contingency Management (CM)

Active Comparator: Non-contingent Control
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.
Behavioral: Non-Contingent Control
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.




Primary Outcome Measures :
  1. Rate of Attrition to measure acceptability of PEth-based CM Intervention [ Time Frame: 26 weeks of treatment (repeated measure) through study completion ]
    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.

  2. Acceptability of PEth-based CM: Client Satisfaction Questionnaire-8 [ Time Frame: Weeks 4, 8, 12, 16, 20, and 26; repeated measure to assess change in satisfaction through study completion ]
    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).

  3. Qualitative interviews to assess satisfaction, feasibility and acceptability of PEth-based CM Intervention using Theory Domains Framework (TDF) [ Time Frame: Weeks 4, 12, and 26; repeated measure to assess change in satisfaction, feasibility, and tolerability through study completion ]
    Assessed by TDF to encode interviews to provide comprehensive, theory-informed data to identify determinants of satisfaction, feasibility and acceptability of intervention

  4. Incidence of alcohol abstinence assessed by PEth biomarker [ Time Frame: 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 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

  5. Efficacy of PEth-based CM in Stabilization of Housing Status [ Time Frame: Weeks 1, 4, 8, 12, 16, 20, and 26; repeated measure to assess change of housing through study completion ]
    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.


Secondary Outcome Measures :
  1. Self-Reported Alcohol Usage [ Time Frame: 26 weeks of treatment (repeated measure) through study completion ]
    Days self-reported abstinence, drinking or heavy drinking measured by the Alcohol Timeline Follow Back

  2. Alcohol Usage as measured by Urine Ethyl Glucuronide (uEtG) [ Time Frame: 26 weeks of treatment (repeated measure) through study completion ]
    uEtG collected and measured to determine alcohol usage in last 1-4 days; uEtG greater or equal to 100 ng/ml is identified as recent drinking occurrence

  3. Visual Analog Scale - Alcohol Cravings [ Time Frame: 26 weeks of treatment (repeated measure) through study completion ]
    Assessed using a 10cm visual analog scale anchored at 0 (no cravings) and 100 (most intense craving possible)

  4. The Addiction Severity Index Lite [ Time Frame: Weeks 1, 4, 8, 12, 16, 20, and 26 (repeated measure) through study completion ]
    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)


Other Outcome Measures:
  1. Short-Form Health Survey-12 [ Time Frame: Weeks 4, 8, 12, 16, 20, and 26 (repeated measure) through study completion ]
    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.

  2. Non-Study Resource Form for Medical and Criminal Justice Utilization [ Time Frame: Weeks 4, 8, 12, 16, 20, and 26 through study completion ]
    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.

  3. Substance Use Test [ Time Frame: 26 weeks of treatment (repeated measure) through study completion ]
    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

  4. Cigarette Consumption [ Time Frame: 26 weeks of treatment (repeated measure) through study completion ]
    Assessed with the Cigarette Timeline Follow Back to measure smoking and other nicotine use

  5. Emotional and Executive Functioning [ Time Frame: Week 1 and 26 (repeated measure) through study completion ]
    Using NIH Toolbox, a brief, comprehensive, standardized assessment that is administered by computer

  6. Fagerstrom Test for Nicotine Dependence [ Time Frame: 26 weeks of treatment (repeated measure) through study completion ]
    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

  7. Alcohol-Related Incentive Salience [ Time Frame: Weeks 1, 4, 8, 12, 16, 20, and 26 (repeated measure) through study completion ]
    Self-rating instrument that provides a total and two subscale scores that measure some cognitive aspects of alcohol cravings

  8. Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES) [ Time Frame: Weeks 1, 4, 8, 12, 16, 20, and 26 (repeated measure) through study completion ]
    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.

  9. Rate of Adverse Events [ Time Frame: 26 weeks of treatment (repeated measure) through study completion ]
    Risks related to suicidality, dangerous alcohol use and withdrawal symptoms will be assessed



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. One heavy drinking episode (men > 4 standard drinks (SDs), women > 3 SDs) in the prior 30 days;
  2. DSM-5 diagnosis of a current Alcohol Use Disorder (AUD) as assessed by the Structured Clinical Interview for Diagnostic and Statistical Manual 5 (DSM-5);
  3. Age 18-65 years;
  4. Currently housed at Catholic Charities Spokane; and
  5. Previously, literally homeless or unstably housed (e.g., couch surfing) for > 1 month

Exclusion Criteria:

  1. Current diagnosis of substance use disorder (other than AUD and tobacco), severe;
  2. Inability to provide informed consent based on the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR);
  3. Alcohol withdrawal-related seizure or hospitalization in prior 12 months; and
  4. Psychiatrically or medically unsafe to participate, as assessed by the PI.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04038021


Contacts
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Contact: Elizabeth Fraser, MSc 509-368-6940 elizabeth.fraser@wsu.edu

Locations
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United States, Washington
Catholic Charities of Eastern Washington Recruiting
Spokane, Washington, United States, 99202
Contact: Kelly Keenan, MURP    509-960-8648    kelly.keenan@cceasternwa.org   
Sponsors and Collaborators
Washington State University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
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Principal Investigator: Michael G McDonell, PhD Washington State University
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Responsible Party: Michael McDonell, Associate Professor, Washington State University
ClinicalTrials.gov Identifier: NCT04038021    
Other Study ID Numbers: 17752
R21AA027045-01A1 ( U.S. NIH Grant/Contract )
First Posted: July 30, 2019    Key Record Dates
Last Update Posted: March 31, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michael McDonell, Washington State University:
Unstably Housed
Homeless
Additional relevant MeSH terms:
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Alcoholism
Alcohol Drinking
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders