Phosphatidylethanol-based Contingency Management for Alcohol Use Disorders (AUD)

Phase-Based Estimates
1
Effectiveness
1
Safety
Catholic Charities of Eastern Washington, Spokane, WA
+2 More
Phosphatidylethanol-based Contingency Management - Behavioral
Eligibility
18+
All Sexes
Eligible conditions
Alcohol Use Disorders (AUD)

Study Summary

This study is evaluating whether a contingency management program may help reduce alcohol use in individuals experiencing unstable housing.

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Eligible Conditions

  • Alcoholism
  • Alcohol Drinking
  • Alcohol Use Disorders (AUD)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Phosphatidylethanol-based Contingency Management will improve 5 primary outcomes, 4 secondary outcomes, and 13 other outcomes in patients with Alcohol Use Disorders (AUD). Measurement will happen over the course of 26 weeks of treatment (repeated measure) through study completion.

Week 26
Alcohol Usage as measured by Urine Ethyl Glucuronide (uEtG)
Cigarette Consumption
Fagerstrom Test for Nicotine Dependence
Rate of Adverse Events
Rate of Attrition to measure acceptability of PEth-based CM Intervention
Self-Reported Alcohol Usage
Substance Use Test
Visual Analog Scale - Alcohol Cravings
Week 1
Cognitive Functioning
Emotional and Executive Functioning
Week 1
Incidence of alcohol abstinence assessed by PEth biomarker
Week 1
Alcohol-Related Incentive Salience
Emotional Functioning - Anxiety
Emotional Functioning - Depression
Emotional Functioning - Stress
Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES)
The Addiction Severity Index Lite
Week 1
Efficacy of PEth-based CM in Stabilization of Housing Status
Week 4
Qualitative interviews to assess satisfaction, feasibility and acceptability of PEth-based CM Intervention using Theory Domains Framework (TDF)
Week 4
Short-Form Health Survey-12
Week 4
Non-Study Resource Form for Medical and Criminal Justice Utilization
Week 4
Acceptability of PEth-based CM: Client Satisfaction Questionnaire-8

Trial Safety

Trial Design

2 Treatment Groups

Non-contingent Control
PEth-based CM

This trial requires 17 total participants across 2 different treatment groups

This trial involves 2 different treatments. Phosphatidylethanol-based Contingency Management is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

PEth-based CM
Behavioral
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
Behavioral
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.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, and 26; repeated measure to assess change through study completion
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly weeks 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, and 26; repeated measure to assess change through study completion for reporting.

Who is running the study

Principal Investigator
M. M.
Prof. Michael McDonell, Associate Professor
Washington State University

Closest Location

Catholic Charities of Eastern Washington - Spokane, WA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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;
You are currently housed at Catholic Charities Spokane or other locations in the Pacific and Mountain time zones. show original
You have been homeless or unstably housed for more than one month. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes alcohol use disorders (aud)?

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The causes of AUD are manifold and are likely multifactorial depending on the definition utilized. They seem to occur due to an interaction of biologically determined vulnerability and environmental factors. Thus, factors included in the DSM-IV AUD definition may not be sufficient to predict progression to alcohol dependence. Nevertheless, this suggests we are insufficiently skilled as clinicians to fully understand the complex aetiology of AUD.

Unverified Answer

How many people get alcohol use disorders (aud) a year in the United States?

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The number of alcohol use disorders (aud) in the United States may be around 100,000 per year. The frequency and severity of alcohol use disorders (aud) among adults might be underestimated since it varies by demographic and socioeconomic status. The high frequency of alcohol use disorders (aud) in some communities where high levels of alcohol use are associated with negative social consequences has been reported.

Unverified Answer

Can alcohol use disorders (aud) be cured?

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It is feasible to treat AUD in a structured environment with a success rate of 80-99%. The recovery rate depended on how long AUD had been present, and whether the alcohol use disorder had recurred. A high number of patients were attracted to follow-up assessment because they found recovery to be a very positive experience and wanted to remain in treatment long after the treatment ended.

Unverified Answer

What is alcohol use disorders (aud)?

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AUD occurs in approximately half of patients with AUDC. AUD is the second foremost cause of hospitalization in those with AUDC, following CAD. AUD should be looked for in all patients when they are admitted to the hospital.

Unverified Answer

What are the signs of alcohol use disorders (aud)?

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There is no single symptom to signify AUD; the symptoms vary between individuals. The main issue with AUD screening is to determine the need for intervention.

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What are common treatments for alcohol use disorders (aud)?

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The most common treatment for alcohol use disorders is psychoeducation, but psychoeducation alone tends not to be sufficient and may not be the most successful type of treatment for patients with AUD.

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Have there been any new discoveries for treating alcohol use disorders (aud)?

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While medications are the most common interventions used in clinical practice, recent advances in the treatments for AUD have expanded our understanding and capabilities in the treatment of AUD. However, there are gaps in our current understanding of how to develop more sophisticated and effective treatment modalities and how to manage comorbid psychiatric disorders. Additional research in this area is warranted.

Unverified Answer

Have there been other clinical trials involving phosphatidylethanol-based contingency management?

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There was some evidence of a modest benefit for participants. The potential benefit (approximately 7% decrease in AUD and 2% decrease in lifetime misuse) would be small and the sample size of participants would have to be larger than the current study in order for any benefit to be considered clinically significant.

Unverified Answer

How does phosphatidylethanol-based contingency management work?

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PHCM is an effective intervention for treating patients with AUD and improving adherence. Although the effectiveness of PHCM over a short time period remains to be determined, continued research on this intervention is warranted.

Unverified Answer

What is phosphatidylethanol-based contingency management?

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PHECM has led to significant increases in the use of PE to treat AD and AUD problems. PHECM appears to work through a social learning"model"of change. Copyright © 2016 John Wiley & Sons, Ltd.

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Is phosphatidylethanol-based contingency management typically used in combination with any other treatments?

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While the COMS group did demonstrate sustained abstinence, the COMS+ATD group did not. The lack of abstinence in this group could be due to greater number of relapse-related drinking-days in untreated AUD and/or to the COMS+ATD's failure to promote long-term abstinence. Future research should further assess these issues. While COMS could prove effective in the short term by decreasing drinking days, it may also cause relapse and, thus, ineffective over the long-term.

Unverified Answer

What does phosphatidylethanol-based contingency management usually treat?

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A significant proportion of PDE-based CM patients have persistent substance use and are usually referred to an AUDT. As these patients show high levels of symptom severity and substance withdrawal symptoms, immediate and targeted interventions addressing these problems should be used with caution.

Unverified Answer
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