Cannabinoids and Cerebellar-Motor Functioning

Early Phase 1

Completed

• Conditions: Psychotic Disorders; Cannabis
• Interventions: Drug: Placebo; Drug: THC

• Registration Number: NCT01853020
• Lead Sponsor: Yale University

Brief Summary

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.

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 Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-03-25
• Study First Submitted QC: 2013-05-09
• Study First Posted: 2013-05-14
• Primary Completion: 2015-04-07
• Study Completion: 2015-04-07
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-27
• Last Update Posted: 2022-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Control: small amount of alcohol intravenous (quarter teaspoon), with no THC over 10 minutes
THC	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

VA Connecticut Healthcare System; 🇺🇸 West Haven, Connecticut, United States