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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
  Purpose

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 Intervention Phase
Healthy
 Drug: Naloxone
Drug: Delta-9-THC
Drug: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Assessment of Cannabinoid-opiate Interactions in Humans With a Cannabis Use Disorder and Healthy Subjects

Resource links provided by NLM:

MedlinePlus related topics: Marijuana
U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 56
Study Start Date: July 2011
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • At least one exposure to Cannabis

Exclusion Criteria:

  • Cannabis Naive
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01591629

Contacts
Contact: Christina Luddy, B.S. 203-932-5711 ext 4549 christina.luddy@yale.edu

Locations
United States, Connecticut
VA Connecticut Healthcare System Recruiting
West Haven, Connecticut, United States, 06516
Contact: Christina Luddy, B.S.     203-932-5711 ext 4549     christina.luddy@yale.edu    
Principal Investigator: Deepak D'Souza, M.D.            
Sponsors and Collaborators
Yale University
  More Information

No publications provided

Responsible Party: Deepak C. D'Souza, Associate Professor, Yale University
ClinicalTrials.gov Identifier: NCT01591629     History of Changes
Other Study ID Numbers: 1108008940
Study First Received: April 25, 2012
Last Updated: March 11, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Yale University:
Cannabis
Marijuana
Naloxone
THC
Psychotic Disorders

Additional relevant MeSH terms:
Naloxone
Tetrahydrocannabinol
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
 Central Nervous System Agents
Therapeutic Uses
Hallucinogens
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics

ClinicalTrials.gov processed this record on May 23, 2013