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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 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: June 13, 2014
Last verified: June 2014
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01591629

Contacts
Contact: Prerana Purohit, B.A. 203-932-5711 ext 4495 prerana.purohit@yale.edu

Locations
United States, Connecticut
VA Connecticut Healthcare System Recruiting
West Haven, Connecticut, United States, 06516
Contact: Prerana Purohit, B.A.    203-932-5711 ext 4495    prerana.purohit@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: June 13, 2014
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Naloxone
Central Nervous System Agents
Narcotic Antagonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014