Alcohol for Opioid Use Disorder
What You Need to Know Before You Apply
What is the purpose of this trial?
The goal of this clinical trial is to examine whether individuals with co-occurring opioid use disorder and alcohol use (OUD+ALC) experience heightened pain sensitivity, pain-related negative affect, and greater alcohol reinforcement compared with alcohol-only (ALC) or opioid-only (OUD-ALC) users.
The main questions it aims to answer are:
* Aim 1. Do individuals with OUD+ALC experience increased pain and pain-related negative affect during periods of sobriety relative to mono-users of alcohol (ALC only) and opioids (OUD-ALC)?
* Aim 2. Do individuals with OUD+ALC experience greater alcohol-induced analgesia and alcohol reinforcement compared with mono-users of alcohol (ALC only) and opioids (OUD-ALC)?
Participants will:
* Complete a screening session
* Complete one lab session including a comprehensive assessment battery involving multimodal assessments of pain during sobriety
* Complete two experimental lab sessions that will include intravenous (IV) administration of either 80mg% alcohol or placebo (saline), order counterbalanced, to measure alcohol's acute effects on pain and pain-related negative affect
Are You a Good Fit for This Trial?
This trial is for adults who either have opioid use disorder, alcohol use disorder, or both. Participants must be able to safely receive IV alcohol and complete pain assessments. People with certain medical conditions or those unable to participate in lab sessions may not qualify.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Trial Overview
The study tests how people with opioid and/or alcohol use disorders respond to pain before and after receiving IV alcohol versus a placebo (saline). Each participant receives both treatments in separate sessions to compare effects on pain sensitivity.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Participants in this group will be required to 1) Meet the National Institute on Alcohol Abuse and Alcoholism (NIAAA) criteria for heavy drinking (Male: Consuming 5 or more drinks on any day or 15 or more per week; Female: consuming 4 or more on any day or 8 or more drinks per week); 2) Meet DSM-5 criteria for current OUD and; 3) Report using recreational opioids at least weekly (past month).
Participants in this group will be required to 1) Meet DSM-5 criteria for current OUD; 2) Report using recreational opioids at least weekly (past month); 3) Meet "light drinking" criteria (consuming less than or equal to 4 alcoholic drinks per week (female) or less than or equal to 5 alcoholic drinks (men) and; 4) Report at least 1 but no more than 3 binge episodes over the past 12 months.
Participants in this group will be required to meet the National Institute on Alcohol Abuse and Alcoholism (NIAAA) criteria for heavy drinking (Male: Consuming 5 or more drinks on any day or 15 or more per week; Female: consuming 4 or more on any day or 8 or more drinks per week).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ohio State University
Lead Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Collaborator
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