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

This study is currently recruiting participants.

Verified March 2013 by Yale University

Sponsor:

Information provided by (Responsible Party):

Deepak C. D'Souza, Yale University

ClinicalTrials.gov Identifier:

NCT01591629

First received: April 25, 2012

Last updated: March 11, 2013

Last verified: March 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

April 25, 2012

Last Updated Date

March 11, 2013

Start Date ^ICMJE

July 2011

Estimated Primary Completion Date

July 2017 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Behavioral Measures [ Time Frame: 4 test days ] [ Designated as safety issue: No ]

Subjective effects and perceptual alterations will be assessed using the Positive and Negative Symptom Subscale (PANNS).

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01591629 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Visual analog scales [ Time Frame: 4 test days ] [ Designated as safety issue: No ]
Will assess subjective effects, perceptual alterations, and cognitive effects.
Clinician Administered Dissociative States Scales (CADSS) [ Time Frame: 4 test days ] [ Designated as safety issue: No ]
Will measure subjective effects, perceptual alterations, and cognitive effects.
Psychotomimetic States Inventory (PSI) [ Time Frame: 4 test days ] [ Designated as safety issue: No ]
Will assess subjective effects, perceptual alterations, and cognitive effects.
Marijuana Withdrawal Scale [ Time Frame: 4 test days ] [ Designated as safety issue: No ]
Will assess subjective effects, perceptual alterations, and cognitive effects.
Clinical Opiate Withdrawal Scale [ Time Frame: 4 test days ] [ Designated as safety issue: No ]
Will assess subjective effects, perceptual alterations, and cognitive effects.
Marijuana Craving Scale [ Time Frame: 4 test days ] [ Designated as safety issue: No ]
Will assess subjective effects, perceptual alterations, and cognitive effects.
Neuro cognitive battery [ Time Frame: 4 test days ] [ Designated as safety issue: No ]
Will assess cognitive effects.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science

Condition ^ICMJE

Healthy

Intervention ^ICMJE

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.
Drug: Placebo
Placebo

Study Arm (s)

Placebo Comparator: Placebo and Placebo
Intervention: Drug: Placebo
Experimental: Active Naloxone and Placebo
Interventions:
- Drug: Naloxone
- Drug: Placebo
Placebo Comparator: Placebo and Active Delta-9-THC
Interventions:
- Drug: Delta-9-THC
- Drug: Placebo
Experimental: Active Naloxone and Active Delta-9-THC
Interventions:
- Drug: Naloxone
- Drug: Delta-9-THC

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2017

Estimated Primary Completion Date

July 2017 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

At least one exposure to Cannabis

Exclusion Criteria:

Cannabis Naive

Gender

Both

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Christina Luddy, B.S.

203-932-5711 ext 4549

christina.luddy@yale.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01591629

Other Study ID Numbers ^ICMJE

1108008940

Has Data Monitoring Committee

Yes

Responsible Party

Deepak C. D'Souza, Yale University

Study Sponsor ^ICMJE

Yale University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

Information Provided By

Yale University

Verification Date

March 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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