Opioid Use DisorderEarly Phase 1NCT07894276
Pain Sensitivity, Alcohol-Induced Analgesia, and Heavy Drinking in Individuals With Opioid Use Disorder
A Early Phase 1 study testing Alcohol in people with Opioid Use Disorder and Alcohol Intoxication, run by Ohio State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Opioid Use Disorder, Alcohol Intoxication, Pain
- What is being tested?
- Alcohol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Aug 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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 join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Ohio State University
Columbus, Ohio, 43210
Stephanie Gorka, PhD, 614-366-1027, stephanie.gorka@osumc.edu
About this study
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:
Read more
- 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
- Conditions
- Opioid Use Disorder, Alcohol Intoxication, Pain
- Being tested
- Alcohol, Placebo
- Keywords
- Intravenous alcohol administration, Opioid Use Disorder
- Medical subject headings
- Opioid-Related Disorders, Alcoholic Intoxication, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlcoholDrug
Participants will receive 80 mg% intravenous alcohol and saline.
PlaceboDrug
Participants receive placebo (saline) intravenously.
| Study group | Role | What they receive |
|---|---|---|
| Alcohol (ALC) Only Group | Other | 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). Receives: Drug: Alcohol; Drug: Placebo |
| Opioid Use Disorder (OUD) + ALC Group | Other | 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). Receives: Drug: Alcohol; Drug: Placebo |
| OUD-ALC Group | Other | 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. Receives: Drug: Alcohol; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity during the pressure task, measured using a visual analog scale (VAS)
Pain intensity will be reported during the pressure task administered during each of the three laboratory sessions (Baseline, Placebo, and Alcohol). Participants will rate their perceived pain intensity using a numerical rating scale ranging from 0-100.
Measured: Baseline (Visit 1), approximately 7 days later (Visit 2), and approximately 14 days after baseline (Visit 3)
Pain pressure threshold during the pressure task
Pain pressure threshold is estimated by averaging reports across the different runs of the pressure task that is administered at all three lab sessions.
Measured: Baseline (Visit 1), approximately 7 days later (Visit 2), and approximately 14 days after baseline (Visit 3)
Startle eyeblink potentiation during the anticipation task
Startle eyeblink potentiation will be collected during the anticipation task that is administered at all three lab sessions. Startle is a cross-species index of aversive reactivity.
Measured: Baseline (Visit 1), approximately 7 days later (Visit 2), and approximately 14 days after baseline (Visit 3)
Self-reported affect during the anticipation task
At the end of the anticipation task, participants will rate how intense, arousing, and anxiety-provoking the task was on a 1-to-10 scale, with 1 indicating low intensity, arousal, or anxiety and 10 indicating high intensity, arousal, or anxiety.
Measured: Baseline (Visit 1), approximately 7 days later (Visit 2), and approximately 14 days after baseline (Visit 3)
Subjective affective response to alcohol in the lab
Participants will complete the Profile of Mood States (POMS) throughout the placebo and alcohol administration protocols. The individual mood states will be examined and compared across sessions. Higher scores on each POMS subscale indicate a greater degree of the corresponding mood state, while lower scores indicate a lesser degree of that mood state.
Measured: Placebo and Alcohol sessions (Visits 2 and 3), approximately 7 days apart.
Secondary outcomes (1)
Subjective effects of alcohol in the lab
Participants will rate the degree to which they "feel", "like", and "want more" of the infused substance on a visual analog scale ranging from 0 to 100. The "like" and "want more" scales will serve as the primary measures of alcohol liking and wanting, respectively.
Measured: Placebo and Alcohol sessions (Visits 2 and 3), approximately 7 days apart.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Stephanie M Gorka, PhD, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07894276
- Sponsor's protocol ID
- STUDY20252506
- Other IDs
- 1R21AA032964-01
- Status last verified
- Oct 2026
- First submitted
- 16 Sep 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data, including startle eyeblink and behavior, from this project will be submitted to the The National Institute on Alcohol Abuse and Alcoholism Data Archive (NIAAADA) at the subject level along with appropriate supporting documentation to enable efficient use of the data by the research community. We will follow instructions as discussed in the NDA Data Sharing Terms and Conditions.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Sensitivity, Alcohol-Induced Analgesia, and Heavy Drinking in Individuals With Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT07894276
- Acronym / sponsor ID
- STUDY20252506
- Conditions
- Opioid Use Disorder, Alcohol Intoxication, Pain
- Keywords
- Intravenous alcohol administration, Opioid Use Disorder
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 26 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Alcohol (ALC) Only Group | Other | Drug: Alcohol, Drug: PlaceboParticipants 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). |
| Opioid Use Disorder (OUD) + ALC Group | Other | Drug: Alcohol, Drug: PlaceboParticipants 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). |
| OUD-ALC Group | Other | Drug: Alcohol, Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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)
- 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)
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlcoholParticipants will receive 80 mg% intravenous alcohol and saline. | Drug | Alcohol (ALC) Only Group, OUD-ALC Group, Opioid Use Disorder (OUD) + ALC Group |
| PlaceboParticipants receive placebo (saline) intravenously. | Drug | Alcohol (ALC) Only Group, OUD-ALC Group, Opioid Use Disorder (OUD) + ALC Group |
Primary outcome
Pain intensity during the pressure task, measured using a visual analog scale (VAS)
Time frame: Baseline (Visit 1), approximately 7 days later (Visit 2), and approximately 14 days after baseline (Visit 3)
Pain intensity will be reported during the pressure task administered during each of the three laboratory sessions (Baseline, Placebo, and Alcohol). Participants will rate their perceived pain intensity using a numerical rating scale ranging from 0-100.
Pain pressure threshold during the pressure task
Time frame: Baseline (Visit 1), approximately 7 days later (Visit 2), and approximately 14 days after baseline (Visit 3)
Pain pressure threshold is estimated by averaging reports across the different runs of the pressure task that is administered at all three lab sessions.
Startle eyeblink potentiation during the anticipation task
Time frame: Baseline (Visit 1), approximately 7 days later (Visit 2), and approximately 14 days after baseline (Visit 3)
Startle eyeblink potentiation will be collected during the anticipation task that is administered at all three lab sessions. Startle is a cross-species index of aversive reactivity.
Self-reported affect during the anticipation task
Time frame: Baseline (Visit 1), approximately 7 days later (Visit 2), and approximately 14 days after baseline (Visit 3)
At the end of the anticipation task, participants will rate how intense, arousing, and anxiety-provoking the task was on a 1-to-10 scale, with 1 indicating low intensity, arousal, or anxiety and 10 indicating high intensity, arousal, or anxiety.
Subjective affective response to alcohol in the lab
Time frame: Placebo and Alcohol sessions (Visits 2 and 3), approximately 7 days apart.
Participants will complete the Profile of Mood States (POMS) throughout the placebo and alcohol administration protocols. The individual mood states will be examined and compared across sessions. Higher scores on each POMS subscale indicate a greater degree of the corresponding mood state, while lower scores indicate a lesser degree of that mood state.
1 secondary outcome
Subjective effects of alcohol in the lab
Time frame: Placebo and Alcohol sessions (Visits 2 and 3), approximately 7 days apart.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified data, including startle eyeblink and behavior, from this project will be submitted to the The National Institute on Alcohol Abuse and Alcoholism Data Archive (NIAAADA) at the subject level along with appropriate supporting documentation to enable efficient use of the data by the research community. We will follow instructions as discussed in the NDA Data Sharing Terms and Conditions.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Alcohol in people with Opioid Use Disorder and Alcohol Intoxication, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephanie Gorka, PhD (614-366-1027, stephanie.gorka@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity during the pressure task, measured using a visual analog scale (VAS) (time frame: Baseline (Visit 1), approximately 7 days later (Visit 2), and approximately 14 days after baseline (Visit 3)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.