Prescription Medication Interactions

Opioid Use Clinical Trial

Official title:

Prescription Medications: Pharmacodynamics and Interaction Effects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04315181
• Other study ID #: 46591
• Secondary ID: R01DA016718
• Status: Completed
• Phase: Phase 1
• Start date: March 25, 2019
• Est. completion date: May 6, 2023

Study information

• Verified date: January 2024
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: May 6, 2023
• Est. primary completion date: May 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Opioid Use
• Sedative Use

Intervention

Drug:
• Opioid Agonist
Active opioid agonist or placebo, administered orally
• Sedatives
Active sedative or placebo, administered orally

Locations

Country	Name	City	State
United States	Center on Drug and Alcohol Research	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Sharon Walsh	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).
Secondary	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).
Secondary	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).