Cannabinoids, Neural Synchrony, and Information Processing

NCT ID: NCT00708994

Last Updated: 2022-03-09

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

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-25

Study Completion Date

2012-12-03

Brief Summary

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The study examines the effects of delta-9-tetrahydrocannabinol (Δ9-THC), the principal active ingredient of cannabis, on neural synchrony. Neural synchrony is studied using electroencephalography (EEG).

Detailed Description

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Conditions

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Cannabis 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

* Very low dose (0.0015 mg/kg = 0.21 mg in a 70kg individual) THC, dissolved in alcohol. Administered intravenously over 10 minutes.
* Low dose (0.015 mg/kg = 1.05 mg in a 70kg individual) THC, dissolved in alcohol. This dose is roughly equivalent to smoking approximately 1/4th of a marijuana cigarette, or "joint". Administered intravenously over 10 minutes.
* Medium dose (0.03 mg/kg = 2.1 mg in a 70 kg individual) THC, dissolved in alcohol. This dose is roughly equivalent to smoking approximately 1/2 of a marijuana cigarette, or "joint". Administered intravenously over 10 minutes.

Group Type ACTIVE_COMPARATOR

THC

Intervention Type DRUG

* Very low dose (0.0015 mg/kg = 0.21 mg in a 70kg individual) THC, dissolved in alcohol. Administered intravenously over 10 minutes.
* Low dose (0.015 mg/kg = 1.05 mg in a 70kg individual) THC, dissolved in alcohol. This dose is roughly equivalent to smoking approximately 1/4th of a marijuana cigarette, or "joint". Administered intravenously over 10 minutes.
* Medium dose (0.03 mg/kg = 2.1 mg in a 70 kg individual) THC, dissolved in alcohol. This dose is roughly equivalent to smoking approximately 1/2 of a marijuana cigarette, or "joint". Administered intravenously over 10 minutes.

Placebo

• Control: small amount of alcohol intravenous (quarter teaspoon), with no THC over 10 minutes

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

• Control: small amount of alcohol intravenous (quarter teaspoon), with no THC over 10 minutes

Interventions

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THC

* Very low dose (0.0015 mg/kg = 0.21 mg in a 70kg individual) THC, dissolved in alcohol. Administered intravenously over 10 minutes.
* Low dose (0.015 mg/kg = 1.05 mg in a 70kg individual) THC, dissolved in alcohol. This dose is roughly equivalent to smoking approximately 1/4th of a marijuana cigarette, or "joint". Administered intravenously over 10 minutes.
* Medium dose (0.03 mg/kg = 2.1 mg in a 70 kg individual) THC, dissolved in alcohol. This dose is roughly equivalent to smoking approximately 1/2 of a marijuana cigarette, or "joint". Administered intravenously over 10 minutes.

Intervention Type DRUG

Placebo

• Control: small amount of alcohol intravenous (quarter teaspoon), with no THC over 10 minutes

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Men and women aged 18 and 55 years (extremes included) on the day of the first dosing.
* Exposed to cannabis at least once.

Exclusion Criteria

1. Cannabis naïve
2. Positive pregnancy screen during screening
3. Hearing deficits
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Deepak C. D'Souza

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Deepak D'Souza, 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

References

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Ranganathan M, Radhakrishnan R, Addy PH, Schnakenberg-Martin AM, Williams AH, Carbuto M, Elander J, Pittman B, Andrew Sewell R, Skosnik PD, D'Souza DC. Tetrahydrocannabinol (THC) impairs encoding but not retrieval of verbal information. Prog Neuropsychopharmacol Biol Psychiatry. 2017 Oct 3;79(Pt B):176-183. doi: 10.1016/j.pnpbp.2017.06.019. Epub 2017 Jun 20.

Reference Type DERIVED
PMID: 28642081 (View on PubMed)

Other Identifiers

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5R21DA020750-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0803003638

Identifier Type: -

Identifier Source: org_study_id

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