Alcohol and Opioids

Phase 1

Completed

• Conditions: Opioid Use; Alcohol Drinking
• Interventions: Drug: Alcohol; Drug: Opioid Agonist

• Registration Number: NCT04300751
• Lead Sponsor: Sharon Walsh

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-05
• Study First Submitted QC: 2020-03-05
• Study First Posted: 2020-03-09
• Study Start: 2021-03-24
• Primary Completion: 2024-11-09
• Study Completion: 2024-11-09
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Alcohol	Alcohol	Participants will receive experimental doses of active or placebo alcohol, p.o. Alcohol/placebo will be administered once per session.
Opioid Agonist/Alcohol Combination	Alcohol	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.
Opioid Agonist/Alcohol Combination	Opioid Agonist	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.
Opioid Agonist	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)
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

Trial Locations

Locations (1)

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States