NCT00708994

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Feb 2008

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 25, 2008

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 3, 2008

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 3, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2012

Completed
Last Updated

March 9, 2022

Status Verified

February 1, 2022

Enrollment Period

4.8 years

First QC Date

July 1, 2008

Last Update Submit

February 23, 2022

Conditions

CannabisPsychotic Disorders

Outcome Measures

Primary Outcomes (2)

  • EEG

    +30

  • Clinician Administered Dissociative Symptoms Scale, Positive and Negative Symptom Scale, Visual Analog Scale

    Baseline, +10, +80

Study Arms (2)

THC

ACTIVE COMPARATOR

* 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.

Drug: THC

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

THCDRUG

* 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.

THC
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Cannabis naïve
  • Positive pregnancy screen during screening
  • Hearing deficits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Connecticut Healthcare System

West Haven, Connecticut, 06516, United States

Location

Related Publications (1)

  • 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.

    PMID: 28642081DERIVED

MeSH Terms

Conditions

Marijuana AbusePsychotic Disorders

Interventions

Dronabinol

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersSchizophrenia Spectrum and Other Psychotic Disorders

Intervention Hierarchy (Ancestors)

CannabinoidsTerpenesHydrocarbonsOrganic Chemicals

Study Officials

  • Deepak D'Souza, MD

    Yale University Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 1, 2008

First Posted

July 3, 2008

Study Start

February 25, 2008

Primary Completion

December 3, 2012

Study Completion

December 3, 2012

Last Updated

March 9, 2022

Record last verified: 2022-02

Locations

US(1)