← Back to all trials
Not Yet Recruiting
NCT07894276
Pain Sensitivity, Alcohol-Induced Analgesia, and Heavy Drinking in Individuals With Opioid Use Disorder
Conditions: Opioid Use Disorder, Alcohol Intoxication, Pain
Sex: All
Ages: 21 Years – 65 Years
Healthy volunteers: No
Phase: EARLY_PHASE1
Enrollment: 90
Sponsor: Ohio State University
Location: Ohio State University Columbus Ohio
Summary
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
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
* Serious medical problems
* Current medical or psychiatric conditions requiring medication for which alcohol is contraindicated (including prescription opioids)
* Any serious medical problems
* Sensitivity or allergy to alcohol
* Body weight \< 110 or \> 210 lbs for alcohol administration
* Injury, trauma, nerve/tissue damage, or deformity prohibiting sensory testing
* Moderate to severe substance use disorders other than alcohol use disorder (AUD) or OUD
* Current severe mental illness, including mania or psychosis
* 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
Source: ClinicalTrials.gov (NCT07894276). StuddyBuddy aggregates publicly available trial information.