Opioid Agonist for Alcohol Consumption

University of Kentucky, Lexington, KY
Alcohol Consumption+1 More ConditionsOpioid Agonist - Drug
21 - 55
All Sexes

Study Summary

This trial will study the effects of alcohol and opioids, alone and in combination. The primary outcomes are subjective ratings of drug liking and other abuse-related effects; physiological outcomes.

Eligible Conditions
  • Alcohol Consumption
  • Opioid Use Disorder

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: These outcomes (visual analog scores, scale of 0-100) will be recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 6.5 hours per session)

Hour 5
Change in Blood pressure
Hour 5
Change in Oxygen Saturation
Hour 5
Change in Respiration Rate
Hour 5
Change in Subject-Rated Outcomes

Trial Safety

Phase-Based Safety

1 of 3

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

Trial Design

3 Treatment Groups

Opioid Agonist
1 of 3
1 of 3
Opioid Agonist/Alcohol Combination
1 of 3

Experimental Treatment

72 Total Participants · 3 Treatment Groups

Primary Treatment: Opioid Agonist · No Placebo Group · Phase 1

Opioid Agonist
Experimental Group · 1 Intervention: Opioid Agonist · Intervention Types: Drug
Experimental Group · 1 Intervention: Alcohol · Intervention Types: Drug
Opioid Agonist/Alcohol CombinationExperimental Group · 2 Interventions: Opioid Agonist, Alcohol · Intervention Types: Drug, Drug
First Studied
Drug Approval Stage
How many patients have taken this drug
FDA approved

Trial Logistics


Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: these outcomes (visual analog scores, scale of 0-100) will be recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 6.5 hours per session)

Who is running the clinical trial?

Sharon WalshLead Sponsor
3 Previous Clinical Trials
131 Total Patients Enrolled
Sharon Walsh, PhD2.913 ReviewsPrincipal Investigator - University of Kentucky
University of Kentucky
2 Previous Clinical Trials
67 Total Patients Enrolled
5Patient Review
Dr. Lohr has been my rheumatologist for almost 10 years, and she is wonderful. I know I can be a difficult patient at times, but her no-nonsense approach to dealing with my illness has always been a comfort. In addition to prescribing medication, she explains why certain issues are happening to me and provides advice on things I can do to ease some of the symptoms. I truly believe she knows me and cares about me as a person, not just a patient. When she does my screenings, she is quick to note my progress or lack thereof. We have had indepth discussions about factors that could

Eligibility Criteria

Age 21 - 55 · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are currently using opioids for non-medical purposes.
You have a history of drinking alcohol.

Who else is applying?

What state do they live in?
How old are they?
18 - 65100.0%
What site did they apply to?
University of Kentucky100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%

Frequently Asked Questions

What types of illnesses are treated by Opioid Agonists?

"Opioid Agonist is a common treatment for obstructive hypertrophic cardiomyopathy, and can also be useful in combating communicable diseases, ethylene glycol toxicity, as well as disinfecting the skin." - Anonymous Online Contributor

Unverified Answer

Am I eligible to get involved in this research endeavor?

"This research is hoping to recruit 72 individuals aged 21 and 55 who have a history of alcohol consumption. To be eligible, candidates should exhibit non-medicinal opioid use, prior alcoholic habits, and fall within the aforementioned age range." - Anonymous Online Contributor

Unverified Answer

Has the FDA approved Opioid Agonist as a therapeutic treatment?

"Our safety assessment of opioid agonist, based on the limited data from phase 1 trials, resulted in a rating of 1." - Anonymous Online Contributor

Unverified Answer

How many individuals are participating in this scientific experiment?

"That is correct. Records on clinicaltrials.gov indicate that recruitment for this trial, which was first published in March 2021, is still ongoing. Aiming to include 72 individuals, the research site currently requires enrolment from one location only." - Anonymous Online Contributor

Unverified Answer

Are any new participants being accepted for this trial?

"Affirmative. According to the information posted on clinicaltrials.gov, this medical trial is currently searching for participants and was originally published on March 24th 2021. Updating most recently on October 28th 2022, it aims to enroll 72 patients from a single location." - Anonymous Online Contributor

Unverified Answer

Is eligibility for this trial restricted to those above a certain age?

"This investigation is open to those of legal age and under 55 years old." - Anonymous Online Contributor

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