THC-Gamma: Cannabinoids, Neural Synchrony, and Information Processing

• Sponsor: Yale University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00708994
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 42
• Location: 1
• Arms: 2
• Actual Duration (Months): 57.3
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Cannabis; Psychotic Disorders	Drug: THC; Drug: Placebo	Early Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Cannabinoids, Psychosis, Neural Synchrony, and Information Processing
• Actual Study Start Date: Feb 25, 2008
• Actual Primary Completion Date: Dec 3, 2012
• Actual Study Completion Date: Dec 3, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Drug: 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.
Placebo Comparator: Placebo • Control: small amount of alcohol intravenous (quarter teaspoon), with no THC over 10 minutes	Drug: Placebo; • Control: small amount of alcohol intravenous (quarter teaspoon), with no THC over 10 minutes

Outcome Measures

Primary Outcome Measures

1. EEG [+30]

2. Clinician Administered Dissociative Symptoms Scale, Positive and Negative Symptom Scale, Visual Analog Scale [Baseline, +10, +80]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Connecticut Healthcare System	West Haven	Connecticut	United States	06516

Sponsors and Collaborators

• Yale University
• National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Deepak D'Souza, MD, Yale University Medical School

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Deepak C. D'Souza, Associate Professor, Yale University
• ClinicalTrials.gov Identifier: NCT00708994
• Other Study ID Numbers: 0803003638; 5R21DA020750-02
• First Posted: Jul 3, 2008
• Last Update Posted: Mar 9, 2022
• Last Verified: Feb 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Mental Disorders; Psychotic Disorders

Study Results

No Results Posted as of Mar 9, 2022