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Completed

NCT Number: NCT01853020

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.

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Key information

Conditions

Cannabis Chemically-Induced Disorders Marijuana Abuse Mental Disorders Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders Substance-Related Disorders

Age range

21 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

VA Connecticut Healthcare System

West Haven, Connecticut, 06516, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

THC

Drug

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

Drug

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

Primary outcomes

  1. Cerebellum Dependent Associative Learning (% CRs)

    Time frame: Measured +15 minutes after infusion

    % conditioned responses (CRs) will be measured

  2. Cerebellum Dependent Associative Learning (CR Latency)

    Time frame: Measured +15 minutes after infusion

    conditioned response (CR) Latency will be measured

  3. Completion of the Grooved Pegboard Motor Task (Reaction Time/Accuracy)

    Time frame: Measured +45 minutes after infusion

    Total time taken to complete the grooved pegboard tasks will be the dependent measure.

  4. CANTAB Motor Screening Test (Reaction Time)

    Time frame: Measured +45 minutes after infusion

    Using a touch screen, reaction time to touch a target will be the dependent measures.

  5. CANTAB Motor Screening Test (Accuracy)

    Time frame: Measured +45 minutes after infusion

    Using a touch screen, accuracy to touch a target will be the dependent measures.

  6. Paced Finger Tapping (Correct Responses)

    Time frame: Measured +45 minutes after infusion

    Using a button on a computer keyboard, correct responses will be measured.

  7. Paced Finger Tapping (Reaction Time)

    Time frame: Measured +45 minutes after infusion

    Using a button on a computer keyboard, reaction time and tapping variability will be measured.

Secondary outcomes

  1. THC intoxication, as measured by the Visual Analog Scale (Total Score)

    Time frame: Baseline; +45, +100, +240 minutes after infusion

    0 being none; 100 being completely

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
May 14, 2013
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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