Prescription Medication Interactions

Prescription Medications: Pharmacodynamics and Interaction Effects

This study will examine the effects of doses of opioid/placebo and doses of sedative/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.

Study Overview

• Status: Completed
• Conditions: Opioid Use; Sedative Use
• Intervention / Treatment: Drug: Opioid Agonist; Drug: Sedatives

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Paul Nuzzo, M.A.; Phone Number: 859-257-4581; Email: pnuzz2@email.uky.edu

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40508
      • Center on Drug and Alcohol Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Healthy adults, ages 18-55
• Current non-medical use of opioids and sedatives

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oral opioid agonist; Participants will receive non-therapeutic experimental doses of active or placebo oral opioid agonist. 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: Oral sedative; Participants will receive non-therapeutic experimental doses of active or placebo oral sedative. Active sedative/placebo will be administered once per session and will be administered orally.	Drug: Sedatives; Active sedative or placebo, administered orally
Experimental: Opioid agonist/sedative; Participants will receive non-therapeutic, experimental doses of active opioid agonist/placebo in combination with non-therapeutic, experimental doses of active sedative/placebo. Opioid/placebo and sedative/placebo doses will be administered once during each session. It is possible to receive both active drugs on the same day. Opioid and sedative doses will be administered orally.	Drug: Opioid Agonist; Active opioid agonist or placebo, administered orally; Drug: Sedatives; Active sedative or placebo, administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Subject-Rated Outcomes	Participants will rate their subjective drug effects (ex: drug liking, high) on standardized VAS scales.	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. 8 hours per session).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Oxygen Saturation	Oxygen saturation (measured as a percentage) will be monitored throughout each session.	Oxygen saturation will be recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session).
Change in Respiration Rate	Respiration rate (number of breaths per minute)	Respiration rate will be recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session).
Change in Blood pressure	Systolic and diastolic blood pressure (mm Hg)	Blood pressure will be recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session).

Collaborators and Investigators

• Sponsor: Sharon Walsh
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Sharon L Walsh, Ph.D., University of Kentucky

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2019
• Primary Completion (Actual): May 6, 2023
• Study Completion (Actual): May 6, 2023

Study Registration Dates

• First Submitted: March 17, 2020
• First Submitted That Met QC Criteria: March 17, 2020
• First Posted (Actual): March 19, 2020

Study Record Updates

• Last Update Posted (Actual): January 26, 2024
• Last Update Submitted That Met QC Criteria: January 24, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: opioid; sedative; opiate
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Hypnotics and Sedatives
• Other Study ID Numbers: 46591; R01DA016718 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We have no plans to share individual participant data with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No