The Effects of ∆-9-THC and Naloxone in Humans

Early Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo; Drug: Naloxone; Drug: Delta-9-THC

• Registration Number: NCT01591629
• Lead Sponsor: Yale University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-04
• Study First Submitted: 2012-04-25
• Study First Submitted QC: 2012-05-02
• Study First Posted: 2012-05-04
• Primary Completion: 2012-06-01
• Study Completion: 2012-06-01
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-23
• Last Update Posted: 2022-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• At least one exposure to Cannabis

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Exclusion Criteria

• Cannabis Naive

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo and Placebo	Placebo	-
Active Naloxone and Placebo	Naloxone	-
Active Naloxone and Placebo	Placebo	-
Placebo and Active Delta-9-THC	Delta-9-THC	-
Placebo and Active Delta-9-THC	Placebo	-
Active Naloxone and Active Delta-9-THC	Naloxone	-
Active Naloxone and Active Delta-9-THC	Delta-9-THC	-

Primary Outcome Measures

Name	Time	Method
Behavioral Measures	4 test days	Subjective effects and perceptual alterations will be assessed using the Positive and Negative Symptom Subscale (PANNS).

Secondary Outcome Measures

Name	Time	Method
Marijuana Withdrawal Scale	4 test days	Will assess subjective effects, perceptual alterations, and cognitive effects.
Visual analog scales	4 test days	Will assess subjective effects, perceptual alterations, and cognitive effects.
Clinician Administered Dissociative States Scales (CADSS)	4 test days	Will measure subjective effects, perceptual alterations, and cognitive effects.
Psychotomimetic States Inventory (PSI)	4 test days	Will assess subjective effects, perceptual alterations, and cognitive effects.
Clinical Opiate Withdrawal Scale	4 test days	Will assess subjective effects, perceptual alterations, and cognitive effects.
Marijuana Craving Scale	4 test days	Will assess subjective effects, perceptual alterations, and cognitive effects.
Neuro cognitive battery	4 test days	Will assess cognitive effects.

Trial Locations

Locations (1)

VA Connecticut Healthcare System; 🇺🇸 West Haven, Connecticut, United States