Effects of Delta-9-THC and Iomazenil in Healthy Humans

NCT ID: NCT00982982

Last Updated: 2022-12-05

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

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-11

Study Completion Date

2013-02-22

Brief Summary

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The study aims to examine the combined effects of delta-9-tetrahydrocannabinol (∆-9-THC or THC) and iomazenil on thinking, perception, mood, memory, attention, and electrical activity of the brain (EEG). THC is the active ingredient of marijuana, cannabis, "ganja", or "pot". Iomazenil is a drug that works opposite to drugs like valium. The purpose of this study is to determine whether the administration of iomazenil will alter the effects of THC.

Detailed Description

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Conditions

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Schizophrenia Mental Disorders Psychotic Disorders

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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THC and Iomazenil

* Iomazenil: 3.7 μg/kg intravenously over 10 minutes
* Delta-9-THC (0.015 mg/kg = 1.05 mg in a 70kg individual), dissolved in alcohol. This dose is roughly equivalent to smoking approximately 1/4th of a marijuana cigarette, or "joint". It is administered intravenously for 10 minutes

Group Type ACTIVE_COMPARATOR

THC and Iomazenil

Intervention Type DRUG

* Iomazenil: 3.7 μg/kg intravenously over 10 minutes
* Delta-9-THC (0.015 mg/kg = 1.05 mg in a 70kg individual), dissolved in alcohol. This dose is roughly equivalent to smoking approximately 1/4th of a marijuana cigarette, or "joint". It is administered intravenously for 10 minutes.

Placebo

Control: small amount of alcohol intravenous (quarter teaspoon), with no THC

Group Type PLACEBO_COMPARATOR

Placebo (control)

Intervention Type DRUG

Control: small amount of alcohol intravenous (quarter teaspoon), with no THC

Interventions

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THC and Iomazenil

* Iomazenil: 3.7 μg/kg intravenously over 10 minutes
* Delta-9-THC (0.015 mg/kg = 1.05 mg in a 70kg individual), dissolved in alcohol. This dose is roughly equivalent to smoking approximately 1/4th of a marijuana cigarette, or "joint". It is administered intravenously for 10 minutes.

Intervention Type DRUG

Placebo (control)

Control: small amount of alcohol intravenous (quarter teaspoon), with no THC

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Exposed to cannabis at least once in their lifetime

Exclusion Criteria

* Cannabis naïve
* History of hearing deficit
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Yale University

OTHER

Sponsor Role lead

Responsible Party

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Deepak C. D'Souza

Associate Professor of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Deepak C D'Souza, M.D

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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0901004662

Identifier Type: -

Identifier Source: org_study_id

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