Opioid and Cannabinoid Interactions

Shanna Babalonis, PhD10 enrolled

Overview

This study will examine the effects of doses of marijuana/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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Marijuana Usage Opioid Use

Interventions

Vaporized MarijuanaDRUG

Active Marijuana administered through vaporizer

Opioid AgonistDRUG

Active Opioid Agonist administered intranasally

PlaceboDRUG

Experimental, non-therapeutic administration of inactive opioid or marijuana dose(s)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy adults ages 18-50 * Current non-medical use of opioids and marijuana Exclusion Criteria: * Physical dependence on opioids, alcohol benzodiazepines/sedative/hypnotics * Seeking treatment for drug use * Significant medical problems

Locations (1)

University of Kentucky

Lexington, Kentucky, United States

Outcomes

Primary Outcomes

Change in Subject-Rated Outcome - VAS Drug Liking

Participants rated their subjective drug liking on a standardized VAS scale (0 to 100). Low scores mean little to no drug liking. Higher scores mean greater drug liking. Raw data transformed to peak scores.

Time frame: This outcome (visual analog scores, scale of 0-100) was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session) and a peak score was calculated across all these time intervals.

Secondary Outcomes

Change in Oxygen Saturation

Oxygen saturation (measured as a percentage) monitored throughout each session. Raw data transformed to trough scores.

Time frame: Oxygen saturation was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session) and a score was calculated across all these time intervals.

Change in Respiration Rate

Respiration rate (number of breaths per minute). Raw data transformed to trough scores.

Time frame: Respiration rate was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session) and a score was calculated across all these time intervals.

Change in Systolic Blood Pressure

Systolic blood pressure (mm Hg). Raw data transformed to peak scores.

Time frame: Blood pressure was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session) and a peak score was calculated across all these time intervals.

Change in Diastolic Blood Pressure

Diastolic blood pressure (mm Hg). Raw data transformed to peak scores.

Data from ClinicalTrials.gov

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