Clinical Trials Logo
  1. Home
  2. Psychotic Disorders
  3. NCT00708994
  4. Details
NCT00708994 Clinical Trial

Cannabinoids, Neural Synchrony, and Information Processing

Psychotic Disorders Clinical Trial

— THC-Gamma  

Official title:
Cannabinoids, Psychosis, Neural Synchrony, and Information Processing

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00708994
Other study ID # 0803003638
Secondary ID 5R21DA020750-02
Status Completed
Phase Early Phase 1
First received
Last updated
Start date February 25, 2008
Est. completion date December 3, 2012

Study information
Verified date February 2022
Source Yale University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 42
Est. completion date December 3, 2012
Est. primary completion date December 3, 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States VA Connecticut Healthcare System West Haven Connecticut

Sponsors (2)
Lead Sponsor Collaborator
Yale University National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary EEG +30
Primary Clinician Administered Dissociative Symptoms Scale, Positive and Negative Symptom Scale, Visual Analog Scale Baseline, +10, +80
See also
  Status Clinical Trial Phase
Completed NCT05321602 - Study to Evaluate the PK Profiles of LY03010 in Patients With Schizophrenia or Schizoaffective Disorder Phase 1
Terminated NCT03230097 - This Study Tests Whether BI 409306 Prevents Patients With a Specific Type of Mental Illness (Attenuated Psychosis Syndrome) From Becoming Worse. This Study Looks at How Well Patients Tolerate the Medicine and How Effective it is Over 1 Year Phase 2
Completed NCT03497663 - VIA Family - Family Based Early Intervention Versus Treatment as Usual N/A
Active, not recruiting NCT05726617 - Avatar Intervention for the Treatment of Cannabis Use Disorder in Patients With Severe Mental Health Disorders N/A
Not yet recruiting NCT03807388 - ReMindCare App for Patients From First Episode of Psychosis Unit. N/A
Recruiting NCT02874573 - Tocilizumab in Schizophrenia Phase 1
Completed NCT02906553 - The Role of Nitric Oxide in Cognition in Schizophrenia N/A
Terminated NCT02584114 - Brain Effects of Memory Training in Early Psychosis N/A
Terminated NCT02841956 - Reducing Duration of Untreated Psychosis Through Rapid Identification and Engagement N/A
Withdrawn NCT02213887 - Study of the Effects of Pantoprazole on Levels of Prescribed Psychiatric Medications Phase 4
Completed NCT01981356 - Acceptance and Commitment Therapy for the Inpatient Treatment of Psychosis Phase 0
Recruiting NCT02848469 - Irish Omega-3 Study Phase 2
Recruiting NCT02009969 - Serial Comparisons of Abdominal and Neurological MRI Scans N/A
Completed NCT02648321 - Motivational Intervention for Physical Activity in Psychosis N/A
Enrolling by invitation NCT00762866 - Psychiatric Genotype/Phenotype Project Repository
Completed NCT00484302 - Specialized Addiction Treatment Versus Treatment as Usual for Young Patients With Cannabis Abuse and Psychosis N/A
Completed NCT00130923 - Risperidone Long-acting Versus Oral Risperidone in Patients With Schizophrenia and Alcohol Use Disorder Phase 4
Completed NCT00455234 - Rapid Tranquillization Trial: TREC-India II Phase 3
Completed NCT00844922 - Safety of Org 34517 900 mg in Patients Who Received Org 34517 in a Previous Trial (Study 28133/P05842) Phase 2
Completed NCT00253240 - Diabetes Screening, Risk Management and Disease Management in a High-Risk Mental Health Population