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Alcohol and Opioids

Primary Purpose

Opioid Use, Alcohol Drinking

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Alcohol
Opioid Agonist
Sponsored by
Sharon Walsh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Opioid Use focused on measuring opioid, opiate, alcohol

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of KentuckyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Alcohol

Opioid Agonist

Opioid Agonist/Alcohol Combination

Arm Description

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

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in Oxygen Saturation
Oxygen saturation (measured as a percentage) will be monitored throughout each session
Change in Respiration Rate
Respiration rate (number of breaths per minute)
Change in Blood pressure
Systolic and diastolic blood pressure (mm Hg)

Full Information

First Posted
March 5, 2020
Last Updated
October 28, 2022
Sponsor
Sharon Walsh
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1. Study Identification

Unique Protocol Identification Number
NCT04300751
Brief Title
Alcohol and Opioids
Official Title
Interactions of Alcohol and Opioids: Pharmacodynamic Effects
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 24, 2021 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sharon Walsh

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use, Alcohol Drinking
Keywords
opioid, opiate, alcohol

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Masking Description
This is a randomized, double-blind, double-dummy, placebo-controlled, within-subjects design
Allocation
Randomized
Enrollment
72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Alcohol
Arm Type
Experimental
Arm Description
Participants will receive experimental doses of active or placebo alcohol, p.o. Alcohol/placebo will be administered once per session.
Arm Title
Opioid Agonist
Arm Type
Experimental
Arm Description
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
Arm Title
Opioid Agonist/Alcohol Combination
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Alcohol
Intervention Description
Active alcohol or placebo, administered orally
Intervention Type
Drug
Intervention Name(s)
Opioid Agonist
Intervention Description
Active opioid agonist or placebo, administered orally
Primary Outcome Measure Information:
Title
Change in Subject-Rated Outcomes
Description
Participants will rate their subjective drug effects (ex: drug liking, high) on standardized VAS scales.
Time Frame
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)
Secondary Outcome Measure Information:
Title
Change in Oxygen Saturation
Description
Oxygen saturation (measured as a percentage) will be monitored throughout each session
Time Frame
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)
Title
Change in Respiration Rate
Description
Respiration rate (number of breaths per minute)
Time Frame
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)
Title
Change in Blood pressure
Description
Systolic and diastolic blood pressure (mm Hg)
Time Frame
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stevie Britch, PhD
Phone
8592574581
Email
Stevie.Britch@uky.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Paul Nuzzo, MA
Phone
8593230002
Email
Paul.nuzzo@uky.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon Walsh, PhD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40508
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Nuzzo, MA
Phone
859-323-0002
Email
Paul.nuzzo@uky.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We have no plans to share individual participant data with other researchers.

Learn more about this trial

Alcohol and Opioids

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