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Phosphatidylethanol-Based Contingency Management for Housing

Primary Purpose

Alcohol Use Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Phosphatidylethanol-based Contingency Management
Non-Contingent Control
Sponsored by
Washington State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use Disorder focused on measuring Unstably Housed, Homeless

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Two heavy drinking episodes (Assigned Male at Birth > 4 standard drinks (SDs), Assigned Female at Birth > 3 SDs) in the prior 14 days OR >14 drinks in the past 2 weeks, confirmed by a PEth level >=20 ng/ml
  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 years;
  4. Currently housed at Catholic Charities Spokane or other locations in the Pacific and Mountain time zones; 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) and/or age over 65 and Inability to provide informed consent based on the mini-Montreal Cognitive Assessment (mini-MoCA);
  3. Alcohol withdrawal-related seizure or hospitalization in prior 12 months; and
  4. Psychiatrically or medically unsafe to participate, as assessed by the PI.

Sites / Locations

  • Catholic Charities of Eastern Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PEth-based CM

Non-contingent Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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).
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
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
Efficacy of PEth-based CM in Stabilization of Housing Status
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

Self-Reported Alcohol Usage
Days self-reported abstinence, drinking or heavy drinking measured by the Alcohol Timeline Follow Back
Alcohol Usage as measured by Urine Ethyl Glucuronide (uEtG)
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
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)

Full Information

First Posted
July 24, 2019
Last Updated
April 25, 2023
Sponsor
Washington State University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT04038021
Brief Title
Phosphatidylethanol-Based Contingency Management for Housing
Official Title
Phosphatidylethanol-Based Contingency Management to Reduce Alcohol Use and Improve Housing Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
January 13, 2020 (Actual)
Primary Completion Date
August 23, 2022 (Actual)
Study Completion Date
October 27, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington State University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 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.
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 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 6 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, 6 months of non-contingent control for submitting samples each week for the first 4 weeks then every 2 weeks for 4 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 the 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder
Keywords
Unstably Housed, Homeless

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PEth-based CM
Arm Type
Experimental
Arm Description
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.
Arm Title
Non-contingent Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Phosphatidylethanol-based Contingency Management
Other Intervention Name(s)
Contingency Management (CM)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Non-Contingent Control
Intervention Description
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 Measure Information:
Title
Rate of Attrition to measure acceptability of PEth-based CM Intervention
Description
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.
Time Frame
26 weeks of treatment (repeated measure) through study completion
Title
Acceptability of PEth-based CM: Client Satisfaction Questionnaire-8
Description
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).
Time Frame
Weeks 4, 8, 12, 16, 20, and 26; repeated measure to assess change in satisfaction through study completion
Title
Qualitative interviews to assess satisfaction, feasibility and acceptability of PEth-based CM Intervention using Theory Domains Framework (TDF)
Description
Assessed by TDF to encode interviews to provide comprehensive, theory-informed data to identify determinants of satisfaction, feasibility and acceptability of intervention
Time Frame
Weeks 4, 12, and 26; repeated measure to assess change in satisfaction, feasibility, and tolerability through study completion
Title
Incidence of alcohol abstinence assessed by PEth biomarker
Description
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
Time Frame
Weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, and 26; repeated measure to assess change through study completion
Title
Efficacy of PEth-based CM in Stabilization of Housing Status
Description
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.
Time Frame
Weeks 1, 4, 8, 12, 16, 20, and 26; repeated measure to assess change of housing through study completion
Secondary Outcome Measure Information:
Title
Self-Reported Alcohol Usage
Description
Days self-reported abstinence, drinking or heavy drinking measured by the Alcohol Timeline Follow Back
Time Frame
26 weeks of treatment (repeated measure) through study completion
Title
Alcohol Usage as measured by Urine Ethyl Glucuronide (uEtG)
Description
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
Time Frame
26 weeks of treatment (repeated measure) through study completion
Title
The Addiction Severity Index Lite
Description
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)
Time Frame
Weeks 1, 4, 8, 12, 16, 20, and 26 (repeated measure) through study completion
Other Pre-specified Outcome Measures:
Title
Short-Form Health Survey-12
Description
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.
Time Frame
Weeks 4, 8, 12, 16, 20, and 26 (repeated measure) through study completion
Title
Non-Study Resource Form for Medical and Criminal Justice Utilization
Description
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.
Time Frame
Weeks 4, 8, 12, 16, 20, and 26 through study completion
Title
Substance Use Test
Description
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
Time Frame
26 weeks of treatment (repeated measure) through study completion
Title
Cigarette Consumption
Description
Assessed with the Cigarette Timeline Follow Back to measure smoking and other nicotine use
Time Frame
26 weeks of treatment (repeated measure) through study completion
Title
Cognitive Functioning
Description
Using a battery of cognitive tests from Test My Brain
Time Frame
Week 1 and 26 (repeated measure) through study completion
Title
Fagerstrom Test for Nicotine Dependence
Description
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
Time Frame
26 weeks of treatment (repeated measure) through study completion
Title
Alcohol-Related Incentive Salience
Description
Self-rating instrument that provides a total and two subscale scores that measure some cognitive aspects of alcohol cravings
Time Frame
Weeks 1, 4, 8, 12, 16, 20, and 26 (repeated measure) through study completion
Title
Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES)
Description
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.
Time Frame
Weeks 1, 4, 8, 12, 16, 20, and 26 (repeated measure) through study completion
Title
Rate of Adverse Events
Description
Risks related to suicidality, dangerous alcohol use and withdrawal symptoms will be assessed
Time Frame
26 weeks of treatment (repeated measure) through study completion
Title
Emotional Functioning - Depression
Description
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).
Time Frame
Weeks 1, 4, 8, 12, 16, 20, and 26 (repeated measure) through study completion
Title
Emotional Functioning - Anxiety
Description
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).
Time Frame
Weeks 1, 4, 8, 12, 16, 20, and 26 (repeated measure) through study completion
Title
Emotional Functioning - Stress
Description
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)
Time Frame
Weeks 1, 4, 8, 12, 16, 20, and 26 (repeated measure) through study completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Two heavy drinking episodes (Assigned Male at Birth > 4 standard drinks (SDs), Assigned Female at Birth > 3 SDs) in the prior 14 days OR >14 drinks in the past 2 weeks, confirmed by a PEth level >=20 ng/ml 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); Age >=18 years; Currently housed at Catholic Charities Spokane or other locations in the Pacific and Mountain time zones; and Previously, literally homeless or unstably housed (e.g., couch surfing) for > 1 month Exclusion Criteria: Current diagnosis of substance use disorder (other than AUD and tobacco), severe; Inability to provide informed consent based on the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) and/or age over 65 and Inability to provide informed consent based on the mini-Montreal Cognitive Assessment (mini-MoCA); Alcohol withdrawal-related seizure or hospitalization in prior 12 months; and Psychiatrically or medically unsafe to participate, as assessed by the PI.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael G McDonell, PhD
Organizational Affiliation
Washington State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Catholic Charities of Eastern Washington
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Phosphatidylethanol-Based Contingency Management for Housing

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