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

Sponsor

Yale University (Other)

Overall Status

Completed

CT.gov ID

NCT01591629

Collaborator

(none)

Enrollment

Location

Arms

6.9

Actual Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Naloxone Drug: Delta-9-THC Drug: Placebo	Early Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

6 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

Assessment of Cannabinoid-opiate Interactions in Humans With a Cannabis Use Disorder and Healthy Subjects

Actual Study Start Date :

Nov 4, 2011

Actual Primary Completion Date :

Jun 1, 2012

Actual Study Completion Date :

Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo and Placebo	Drug: Placebo Placebo
Experimental: Active Naloxone and Placebo	Drug: Naloxone Active Naloxone 18 mcg/kg intravenously over 60 minutes, 2mg IV push, 1mg IV push Drug: Placebo Placebo
Placebo Comparator: Placebo and Active Delta-9-THC	Drug: Delta-9-THC Active Delta-9-THC (0.025mg/Kg) given intravenously over 20 minutes. Drug: Placebo Placebo
Experimental: Active Naloxone and Active Delta-9-THC	Drug: Naloxone Active Naloxone 18 mcg/kg intravenously over 60 minutes, 2mg IV push, 1mg IV push Drug: Delta-9-THC Active Delta-9-THC (0.025mg/Kg) given intravenously over 20 minutes.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Marijuana Withdrawal Scale [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

At least one exposure to Cannabis

Exclusion Criteria:

Cannabis Naive

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Connecticut Healthcare System	West Haven	Connecticut	United States	06516

Sponsors and Collaborators

Yale University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Deepak C. D'Souza, Associate Professor, Yale University

ClinicalTrials.gov Identifier:

NCT01591629

Other Study ID Numbers:

1108008940

First Posted:

May 4, 2012

Last Update Posted:

Mar 9, 2022

Last Verified:

Feb 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Deepak C. D'Souza, Associate Professor, Yale University

Additional relevant MeSH terms:

Dronabinol

Naloxone

Study Results

No Results Posted as of Mar 9, 2022