N-acetylcysteine Effects on Tetrahydrocannabinol

NCT ID: NCT02335060

Last Updated: 2022-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

EARLY_PHASE1

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-02

Study Completion Date

2014-09-16

Brief Summary

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The overall purpose of this study is to examine the effect of N-acetylcysteine (NAC) on the acute effects of Delta-9-tetrahydrocannabinol (THC). This will be tested by pretreating healthy individuals with NAC and then assessing their responses to THC.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Active N-acetylcysteine and Active Delta-9-THC

Group Type EXPERIMENTAL

Delta-9-THC

Intervention Type DRUG

Active Delta-9-THC (0.036mg/Kg) given intravenously.

N-acetylcysteine

Intervention Type DRUG

A pill given orally.

Placebo and Active Delta-9-THC

Group Type PLACEBO_COMPARATOR

Delta-9-THC

Intervention Type DRUG

Active Delta-9-THC (0.036mg/Kg) given intravenously.

Placebo

Intervention Type DRUG

Placebo "sugar" pill given orally with no N-acetylcysteine.

Active N-acetylcysteine and Placebo

Group Type EXPERIMENTAL

N-acetylcysteine

Intervention Type DRUG

A pill given orally.

Placebo

Intervention Type DRUG

Placebo (about a quarter spoon of alcohol with no THC) given intravenously.

Placebo and Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo (about a quarter spoon of alcohol with no THC) given intravenously.

Placebo

Intervention Type DRUG

Placebo "sugar" pill given orally with no N-acetylcysteine.

Interventions

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Delta-9-THC

Active Delta-9-THC (0.036mg/Kg) given intravenously.

Intervention Type DRUG

N-acetylcysteine

A pill given orally.

Intervention Type DRUG

Placebo

Placebo (about a quarter spoon of alcohol with no THC) given intravenously.

Intervention Type DRUG

Placebo

Placebo "sugar" pill given orally with no N-acetylcysteine.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Exposed to Cannabis at least once in lifetime

Exclusion Criteria

* Cannabis Naive
* Individuals with a documented allergy to N-acetylcysteine
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yale University

OTHER

Sponsor Role lead

Responsible Party

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Mohini Ranganathan

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mohini Ranganathan, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University Medical School

Locations

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VA Connecticut Healthcare System

West Haven, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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1402013406

Identifier Type: -

Identifier Source: org_study_id

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