Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

April 25, 2012
June 13, 2014
July 2011
July 2017   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01591629 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
The Effects of ∆-9-THC and Naloxone in Humans
Assessment of Cannabinoid-opiate Interactions in Humans With a Cannabis Use Disorder and Healthy Subjects

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Healthy
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
56
July 2017
July 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • At least one exposure to Cannabis

Exclusion Criteria:

  • Cannabis Naive
Both
18 Years to 55 Years
Yes
Contact: Prerana Purohit, B.A. 203-932-5711 ext 4495 prerana.purohit@yale.edu
United States
 
NCT01591629
1108008940
Yes
Deepak C. D'Souza, Yale University
Yale University
Not Provided
Not Provided
Yale University
June 2014

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