Overview

This trial is active, not recruiting.

Condition healthy
Treatments naloxone, delta-9-thc, placebo
Phase phase 1
Sponsor Yale University
Start date July 2011
End date July 2017
Trial size 56 participants
Trial identifier NCT01591629, 1108008940

Summary

The purpose of this project is to examine the effects of mu-opiate antagonism on the rewarding and reinforcing effects of delta-9-tetrahydrocannabinol (THC), the main psychoactive ingredient of cannabis.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose basic science
Arm
(Placebo Comparator)
placebo
Placebo
(Experimental)
naloxone
Active Naloxone 18 mcg/kg intravenously over 60 minutes, 2mg IV push, 1mg IV push
placebo
Placebo
(Placebo Comparator)
delta-9-thc
Active Delta-9-THC (0.025mg/Kg) given intravenously over 20 minutes.
placebo
Placebo
(Experimental)
naloxone
Active Naloxone 18 mcg/kg intravenously over 60 minutes, 2mg IV push, 1mg IV push
delta-9-thc
Active Delta-9-THC (0.025mg/Kg) given intravenously over 20 minutes.

Primary Outcomes

Measure
Behavioral Measures
time frame: 4 test days

Secondary Outcomes

Measure
Visual analog scales
time frame: 4 test days
Clinician Administered Dissociative States Scales (CADSS)
time frame: 4 test days
Psychotomimetic States Inventory (PSI)
time frame: 4 test days
Marijuana Withdrawal Scale
time frame: 4 test days
Clinical Opiate Withdrawal Scale
time frame: 4 test days
Marijuana Craving Scale
time frame: 4 test days
Neuro cognitive battery
time frame: 4 test days

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

Inclusion Criteria: - At least one exposure to Cannabis Exclusion Criteria: - Cannabis Naive

Additional Information

Official title Assessment of Cannabinoid-opiate Interactions in Humans With a Cannabis Use Disorder and Healthy Subjects
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by Yale University.