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OpenTrials
Completed

NCT Number: NCT01591629

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

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.

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Key information

Conditions

Healthy Chemically-Induced Disorders Marijuana Abuse Mental Disorders Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders Substance-Related Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

VA Connecticut Healthcare System

West Haven, Connecticut, 06516, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At least one exposure to Cannabis

Exclusion criteria

  • Cannabis Naive

Treatment and study plan

naloxone

Drug

Active Naloxone 18 mcg/kg intravenously over 60 minutes, 2mg IV push, 1mg IV push

Delta-9-THC

Drug

Active Delta-9-THC (0.025mg/Kg) given intravenously over 20 minutes.

Placebo

Drug

Placebo

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 4, 2012
Registry last updated
Mar 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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