Cannabinoids and Cerebellar-Motor Functioning

The purpose of this study is to characterize the dose-related effects of delta-9-tetrahydrocannabinol (∆9-THC) in healthy individuals on cerebellum-dependent motor functions.

Study Overview

• Status: Completed
• Conditions: Psychotic Disorders; Cannabis
• Intervention / Treatment: Drug: THC; Drug: Placebo

Detailed Description

The overall aim of the current proposal is to investigate whether acute, IV ∆9-THC administration mediates cerebellar versus forebrain-dependent associative learning in humans as assessed with eyeblink conditioning (EBC). In addition, a battery of motor function tests will also be administered (the CANTAB motor screening test, Grooved Pegboard Motor Task, paced finger tapping).

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • West Haven, Connecticut, United States, 06516
      • VA Connecticut Healthcare System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Must have used cannabis at least once in their lifetime
• No cannabis use in the past month
• Men and women aged 21 to 35 years (extremes included) on the day of the first dosing

Exclusion Criteria:

• Hearing deficits
• Psychiatric or mental disorders
• Hearing Deficits

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: THC; Very low dose (0.0015 mg/kg = 0.21 mg in a 70 kg individual) THC, dissolved in alcohol. Administered intravenously over 10 minutes. Low dose (0.015 mg/kg = 1.05 mg in a 70 kg individual) THC, dissolved in alcohol. This dose is roughly equivalent to smoking approximately ¼ 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 ½ 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 70 kg individual) THC, dissolved in alcohol. Administered intravenously over 10 minutes. Low Dose (0.015 mg/kg = 1.05 mg in a 70 kg individual) THC, dissolved in alcohol. This dose is roughly equivalent to smoking approximately ¼ 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 ½ 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cerebellum Dependent Associative Learning (% CRs)	% conditioned responses (CRs) will be measured	Measured +15 minutes after infusion
Cerebellum Dependent Associative Learning (CR Latency)	conditioned response (CR) Latency will be measured	Measured +15 minutes after infusion
Completion of the Grooved Pegboard Motor Task (Reaction Time/Accuracy)	Total time taken to complete the grooved pegboard tasks will be the dependent measure.	Measured +45 minutes after infusion
CANTAB Motor Screening Test (Reaction Time)	Using a touch screen, reaction time to touch a target will be the dependent measures.	Measured +45 minutes after infusion
CANTAB Motor Screening Test (Accuracy)	Using a touch screen, accuracy to touch a target will be the dependent measures.	Measured +45 minutes after infusion
Paced Finger Tapping (Correct Responses)	Using a button on a computer keyboard, correct responses will be measured.	Measured +45 minutes after infusion
Paced Finger Tapping (Reaction Time)	Using a button on a computer keyboard, reaction time and tapping variability will be measured.	Measured +45 minutes after infusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
THC intoxication, as measured by the Visual Analog Scale (Total Score)	0 being none; 100 being completely	Baseline; +45, +100, +240 minutes after infusion

Collaborators and Investigators

• Sponsor: Yale University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2012
• Primary Completion (Actual): April 7, 2015
• Study Completion (Actual): April 7, 2015

Study Registration Dates

• First Submitted: March 25, 2013
• First Submitted That Met QC Criteria: May 9, 2013
• First Posted (Estimated): May 14, 2013

Study Record Updates

• Last Update Posted (Actual): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 16, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Cannabinoids; EBC; Eyeblink Conditioning
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Psychotic Disorders
• Other Study ID Numbers: 1211011055