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

NCT ID: NCT01591629

Last Updated: 2022-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-04

Study Completion Date

2012-06-01

Brief Summary

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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

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo and Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Active Naloxone and Placebo

Group Type EXPERIMENTAL

Naloxone

Intervention Type DRUG

Active Naloxone 18 mcg/kg intravenously over 60 minutes, 2mg IV push, 1mg IV push

Placebo

Intervention Type DRUG

Placebo

Placebo and Active Delta-9-THC

Group Type PLACEBO_COMPARATOR

Delta-9-THC

Intervention Type DRUG

Active Delta-9-THC (0.025mg/Kg) given intravenously over 20 minutes.

Placebo

Intervention Type DRUG

Placebo

Active Naloxone and Active Delta-9-THC

Group Type EXPERIMENTAL

Naloxone

Intervention Type DRUG

Active Naloxone 18 mcg/kg intravenously over 60 minutes, 2mg IV push, 1mg IV push

Delta-9-THC

Intervention Type DRUG

Active Delta-9-THC (0.025mg/Kg) given intravenously over 20 minutes.

Interventions

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Naloxone

Active Naloxone 18 mcg/kg intravenously over 60 minutes, 2mg IV push, 1mg IV push

Intervention Type DRUG

Delta-9-THC

Active Delta-9-THC (0.025mg/Kg) given intravenously over 20 minutes.

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* At least one exposure to Cannabis

Exclusion Criteria

* Cannabis Naive
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yale University

OTHER

Sponsor Role lead

Responsible Party

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Deepak C. D'Souza

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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VA Connecticut Healthcare System

West Haven, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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1108008940

Identifier Type: -

Identifier Source: org_study_id

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