Phosphatidylethanol-Based Contingency Management for Housing

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-13

Study Completion Date

2022-10-27

Brief Summary

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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.

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Detailed Description

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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

1. 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,
2. 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.

Conditions

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Alcohol Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Phosphatidylethanol-based Contingency Management

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Non-Contingent Control

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Contingency Management (CM)

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes