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Alcohol + Opioids for Opioid Use Disorder

Phase 1
Recruiting
Led By Sharon Walsh, PhD
Research Sponsored by Sharon Walsh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Healthy adults ages 21-55
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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)
Awards & highlights

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.

Who is the study for?
This trial is for healthy adults aged 21-55 who have used alcohol and opioids non-medically in the past. It's not suitable for those physically dependent on opioids, alcohol, benzodiazepines, or sedatives, nor for individuals seeking drug use treatment or with significant medical issues.Check my eligibility
What is being tested?
The study investigates how different doses of alcohol (or a placebo) and an opioid agonist (or a placebo) affect people when taken alone or together. The focus is on participants' subjective feelings towards the drugs and their physiological responses to measure interaction effects.See study design
What are the potential side effects?
Potential side effects may include changes in mood or behavior due to drug liking, as well as physical reactions like drowsiness or nausea from the combination of alcohol and opioid agonists.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 21 and 55 years old and healthy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Subject-Rated Outcomes
Secondary outcome measures
Change in Blood pressure
Change in Oxygen Saturation
Change in Respiration Rate

Trial Design

3Treatment groups
Experimental Treatment
Group I: Opioid Agonist/Alcohol CombinationExperimental Treatment2 Interventions
Participants will receive non-therapeutic, experimental doses of active opioid/placebo in combination with experimental doses of active alcohol placebo. Opioid/placebo and alcohol/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Both opioid and alcohol doses will be administered orally.
Group II: Opioid AgonistExperimental Treatment1 Intervention
Participants will receive non-therapeutic, experimental doses of an active opioid agonist or placebo. Active opioid agonist/placebo will be administered once per session and will be administered orally
Group III: AlcoholExperimental Treatment1 Intervention
Participants will receive experimental doses of active or placebo alcohol, p.o. Alcohol/placebo will be administered once per session.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ethanol
FDA approved
Opioid Agonist
2019
Completed Phase 1
~40

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Sharon WalshLead Sponsor
3 Previous Clinical Trials
87 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,470 Previous Clinical Trials
2,619,658 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

Media Library

Alcohol Clinical Trial Eligibility Overview. Trial Name: NCT04300751 — Phase 1
Opioid Use Disorder Clinical Trial 2023: Alcohol Highlights & Side Effects. Trial Name: NCT04300751 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
Kentucky
How old are they?
18 - 65
What site did they apply to?
University of Kentucky
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Alcohol and Opioids
Sharon Walsh 2021. "Alcohol and Opioids". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04300751.
All > Opiate Addiction
~10 spots leftby Nov 2024
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