Prescription Medication Interactions

Study Overview
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Brief Summary
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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.

Official Title
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Prescription Medications: Pharmacodynamics and Interaction Effects

Conditions
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Opioid Use, Sedative Use

Intervention / Treatment
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* Drug: Opioid Agonist
* Drug: Sedatives


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral opioid agonist<br>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<br>* Active opioid agonist or placebo, administered orally<br>|
| Experimental: Oral sedative<br>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<br>* Active sedative or placebo, administered orally<br>|
| Experimental: Opioid agonist/sedative<br>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<br>* Active opioid agonist or placebo, administered orally<br>Drug: Sedatives<br>* Active sedative or placebo, administered orally<br>|

What is the study measuring?
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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). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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opioid, sedative, opiate