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

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

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01591629

Enrollment

Registered

2012-05-04

Start date

2011-11-04

Completion date

2012-06-01

Last updated

2022-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Cannabis, Marijuana, Naloxone, THC, Psychotic Disorders

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.

Interventions

DRUGNaloxone

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

DRUGDelta-9-THC

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

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* At least one exposure to Cannabis

Exclusion criteria

* Cannabis Naive

Design outcomes

Primary

Measure	Time frame	Description
Behavioral Measures	4 test days	Subjective effects and perceptual alterations will be assessed using the Positive and Negative Symptom Subscale (PANNS).

Secondary

Measure	Time frame	Description
Clinician Administered Dissociative States Scales (CADSS)	4 test days	Will measure subjective effects, perceptual alterations, and cognitive effects.
Psychotomimetic States Inventory (PSI)	4 test days	Will assess subjective effects, perceptual alterations, and cognitive effects.
Marijuana Withdrawal Scale	4 test days	Will assess subjective effects, perceptual alterations, and cognitive effects.
Visual analog scales	4 test days	Will assess subjective effects, perceptual alterations, and cognitive effects.
Marijuana Craving Scale	4 test days	Will assess subjective effects, perceptual alterations, and cognitive effects.
Neuro cognitive battery	4 test days	Will assess cognitive effects.
Clinical Opiate Withdrawal Scale	4 test days	Will assess subjective effects, perceptual alterations, and cognitive effects.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026