Alcohol and Opioids

Sponsor

Sharon Walsh (Other)

Overall Status

Recruiting

CT.gov ID

NCT04300751

Collaborator

(none)

Enrollment

Location

Arms

32.3

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will examine the effects of doses of alcohol/placebo and doses of opioid/placebo, alone and in combination. The primary outcomes are related to pharmacodynamic measures (subjective ratings of drug liking and other abuse-related effects; physiological outcomes) to determine the interaction effects of these compounds.

Condition or Disease	Intervention/Treatment	Phase
Opioid Use Alcohol Drinking	Drug: Alcohol Drug: Opioid Agonist	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Masking Description:

This is a randomized, double-blind, double-dummy, placebo-controlled, within-subjects design

Primary Purpose:

Basic Science

Official Title:

Interactions of Alcohol and Opioids: Pharmacodynamic Effects

Actual Study Start Date :

Mar 24, 2021

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Alcohol Participants will receive experimental doses of active or placebo alcohol, p.o. Alcohol/placebo will be administered once per session.	Drug: Alcohol Active alcohol or placebo, administered orally
Experimental: Opioid Agonist 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	Drug: Opioid Agonist Active opioid agonist or placebo, administered orally
Experimental: Opioid Agonist/Alcohol Combination 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.	Drug: Alcohol Active alcohol or placebo, administered orally Drug: Opioid Agonist Active opioid agonist or placebo, administered orally

Arm

Intervention/Treatment

Experimental: Alcohol

Participants will receive experimental doses of active or placebo alcohol, p.o. Alcohol/placebo will be administered once per session.

Drug: Alcohol

Active alcohol or placebo, administered orally

Experimental: Opioid Agonist

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

Drug: Opioid Agonist

Active opioid agonist or placebo, administered orally

Experimental: Opioid Agonist/Alcohol Combination

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.

Drug: Alcohol

Active alcohol or placebo, administered orally

Drug: Opioid Agonist

Active opioid agonist or placebo, administered orally

Outcome Measures

Primary Outcome Measures

Change in Subject-Rated Outcomes [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)]
Participants will rate their subjective drug eﬀects (ex: drug liking, high) on standardized VAS scales.

Secondary Outcome Measures

Change in Oxygen Saturation [Oxygen saturation will be recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 6.5 hours per session)]
Oxygen saturation (measured as a percentage) will be monitored throughout each session
Change in Respiration Rate [Respiration rate will be recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 6.5 hours per session)]
Respiration rate (number of breaths per minute)
Change in Blood pressure [Blood pressure will be recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 6.5 hours per session)]
Systolic and diastolic blood pressure (mm Hg)

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Healthy adults ages 21-55
Current non-medical use of opioids
Previous alcohol use

Exclusion Criteria:

Physical dependence on opioids, alcohol, or benzodiazepines/sedative/hypnotics
Seeking treatment for drug use
Significant medical problems

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Kentucky	Lexington	Kentucky	United States	40508

Sponsors and Collaborators

Sharon Walsh

Investigators

Principal Investigator: Sharon Walsh, PhD, University of Kentucky

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sharon Walsh, Director of the Center on Drug and Alcohol Research, University of Kentucky

ClinicalTrials.gov Identifier:

NCT04300751

Other Study ID Numbers:

55176

First Posted:

Mar 9, 2020

Last Update Posted:

Jun 21, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Sharon Walsh, Director of the Center on Drug and Alcohol Research, University of Kentucky

opioid

opiate

alcohol

Additional relevant MeSH terms:

Alcohol Drinking

Analgesics, Opioid

Study Results

No Results Posted as of Jun 21, 2021