Pain Sensitivity, Alcohol-Induced Analgesia, and Heavy Drinking in Individuals With Opioid Use Disorder
Key facts
- Who runs it
- Ohio State University
- Where
- Columbus, United StatesSee the site
- Trial code
- Status
- Not yet recruiting
- Phase
- Early phase 1
- People taking part
- 90 people, planned
- Started
- Nov 2026
- Expected to end
- Aug 2028
- Type of study
- Interventional, 3 groups
- Treatments tested
- Alcohol
- Placebo
- Record updated
- 26 October 2026
Who can take part
- Age
- 21 years to 65 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 27 criteriaShow less
Who can take part
- ALC Only Group:
- 21-65 years old
- Required to meet 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); OUD + ALC Group:
- 21-65 years old
- Required to meet 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)
- Meet DSM-5 criteria for current opioid use disorder (OUD)
- Report using recreational opioids at least weekly (past month); OUD-ALC Group:
- 21-65 years old
- Meet DSM-5 criteria for current OUD
- Report using recreational opioids at least weekly (past month)
- Meet "light drinking" criteria (consuming equal to or less than 4 drinks per week for women or consuming equal to or less than 5 drinks per week for men)
- Report at least 1 but no more than 3 binge episodes over the past 12 months
Who cannot take part
- Current medical or psychiatric conditions requiring medication for which alcohol is contraindicated (including prescription opioids)
- Sensitivity or allergy to alcohol
- Moderate to severe substance use disorders other than alcohol use disorder (AUD) or OUD
- Current severe mental illness, including mania or psychosis
- Serious medical problems
- Any serious medical problems
- Body weight < 110 or > 210 lbs for alcohol administration
- Injury, trauma, nerve/tissue damage, or deformity prohibiting sensory testing
- Currently seeking inpatient/intensive treatment for addictive behaviors
- Pregnant or nursing and unwilling to take measures to avoid becoming pregnant during the study (females)
- Chronic pain requiring ongoing pain management within the past three months
- Clinically significant alcohol or opioid withdrawal symptoms the day of the lab sessions, defined as a score >10 on the Clinical Institute Withdrawal Assessment of Alcohol Scale Revised (CIWA-Ar) or a score >12 on the Clinical Opioid Withdrawal Scale (COWS)
- Positive alcohol breath test or opioid urine screen the day of the experimental lab sessions to avoid the potential for alcohol-opioid interactions
- Smoking more than 6 cigarettes per day (or alternative form equivalent)
- Not fluent in English
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 21 and 65 years old?
Where in United States
- Ohio State UniversityColumbus, United StatesContact: Stephanie Gorka, PhDNot yet recruiting
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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
The 3 groups in the trial
- Alcohol (ALC) Only GroupOther group
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).
Treatment: Alcohol and Placebo
- Opioid Use Disorder (OUD) + ALC GroupOther group
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).
Treatment: Alcohol and Placebo
- OUD-ALC GroupOther group
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.
Treatment: Alcohol and Placebo
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Fit questions
- Built from NCT07894276, who can take part
- Record updated
- 26 October 2026