Phosphatidylethanol-Based Contingency Management for Housing

NCT04038021 | Completed DMC

• 2 other identifiers: 17752R21AA027045-01A1
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Use Disorder

Keywords

Unstably Housed; Homeless

Outcome Measures

Primary Outcomes (5)

• 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

  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

Secondary Outcomes (3)

• Self-Reported Alcohol Usage

  26 weeks of treatment (repeated measure) through study completion

• Alcohol Usage as measured by Urine Ethyl Glucuronide (uEtG)

  26 weeks of treatment (repeated measure) through study completion

• The Addiction Severity Index Lite

  Weeks 1, 4, 8, 12, 16, 20, and 26 (repeated measure) through study completion

Other Outcomes (12)

• Short-Form Health Survey-12

  Weeks 4, 8, 12, 16, 20, and 26 (repeated measure) through study completion

• Non-Study Resource Form for Medical and Criminal Justice Utilization

  Weeks 4, 8, 12, 16, 20, and 26 through study completion

• Substance Use Test

  26 weeks of treatment (repeated measure) through study completion

Study Arms (2)

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.

Behavioral: Phosphatidylethanol-based Contingency Management

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.

Behavioral: Non-Contingent Control

Interventions

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.

Also known as: Contingency Management (CM)

PEth-based CM

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.

Non-contingent Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington State University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Catholic Charities of Eastern Washington

Spokane, Washington, 99202, United States

Location

Related Publications (1)

• 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.

  PMID: 38284925 DERIVED

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Michael G McDonell, PhD

  Washington State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 24, 2019
• First Posted: July 30, 2019
• Study Start: January 13, 2020
• Primary Completion: August 23, 2022
• Study Completion: October 27, 2022
• Last Updated: April 27, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)