Alcohol and Opioids

Study Overview
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Brief Summary
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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.

Official Title
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Interactions of Alcohol and Opioids: Pharmacodynamic Effects

Conditions
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Opioid Use, Alcohol Drinking

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Alcohol<br>Participants will receive experimental doses of active or placebo alcohol, p.o. Alcohol/placebo will be administered once per session. | Drug: Alcohol<br>* Active alcohol or placebo, administered orally<br>|
| Experimental: Opioid Agonist<br>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 | Drug: Opioid Agonist<br>* Active opioid agonist or placebo, administered orally<br>|
| Experimental: Opioid Agonist/Alcohol Combination<br>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. | Drug: Alcohol<br>* Active alcohol or placebo, administered orally<br>Drug: Opioid Agonist<br>* Active opioid agonist 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. 6.5 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. 6.5 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. 6.5 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. 6.5 hours per session) | 

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