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

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ClinicalTrials.gov Identifier: NCT01591629
Recruitment Status : Active, not recruiting
First Posted : May 4, 2012
Last Update Posted : November 30, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Naloxone Drug: Delta-9-THC Drug: Placebo Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Assessment of Cannabinoid-opiate Interactions in Humans With a Cannabis Use Disorder and Healthy Subjects
Study Start Date : July 2011
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Behavioral Measures [ Time Frame: 4 test days ]
    Subjective effects and perceptual alterations will be assessed using the Positive and Negative Symptom Subscale (PANNS).


Secondary Outcome Measures :
  1. Visual analog scales [ Time Frame: 4 test days ]
    Will assess subjective effects, perceptual alterations, and cognitive effects.

  2. Clinician Administered Dissociative States Scales (CADSS) [ Time Frame: 4 test days ]
    Will measure subjective effects, perceptual alterations, and cognitive effects.

  3. Psychotomimetic States Inventory (PSI) [ Time Frame: 4 test days ]
    Will assess subjective effects, perceptual alterations, and cognitive effects.

  4. Marijuana Withdrawal Scale [ Time Frame: 4 test days ]
    Will assess subjective effects, perceptual alterations, and cognitive effects.

  5. Clinical Opiate Withdrawal Scale [ Time Frame: 4 test days ]
    Will assess subjective effects, perceptual alterations, and cognitive effects.

  6. Marijuana Craving Scale [ Time Frame: 4 test days ]
    Will assess subjective effects, perceptual alterations, and cognitive effects.

  7. Neuro cognitive battery [ Time Frame: 4 test days ]
    Will assess cognitive effects.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • At least one exposure to Cannabis

Exclusion Criteria:

  • Cannabis Naive
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01591629


Locations
United States, Connecticut
VA Connecticut Healthcare System
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
Yale University
More Information

Responsible Party: Deepak C. D'Souza, Associate Professor, Yale University
ClinicalTrials.gov Identifier: NCT01591629     History of Changes
Other Study ID Numbers: 1108008940
First Posted: May 4, 2012    Key Record Dates
Last Update Posted: November 30, 2017
Last Verified: November 2017

Keywords provided by Deepak C. D'Souza, Yale University:
Cannabis
Marijuana
Naloxone
THC
Psychotic Disorders

Additional relevant MeSH terms:
Naloxone
Dronabinol
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Hallucinogens
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists