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Cannabinoids and Cerebellar-Motor Functioning

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01853020
Recruitment Status : Active, not recruiting
First Posted : May 14, 2013
Last Update Posted : December 2, 2019
Sponsor:
Information provided by (Responsible Party):
Patrick D. Skosnik, 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.

Condition or disease Intervention/treatment Phase
Cannabis Psychotic Disorders Drug: THC Drug: Placebo Phase 1

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Cannabinoids and Cerebellar-Motor Functioning
Actual Study Start Date : December 2012
Actual Primary Completion Date : December 2015
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01853020


Locations
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United States, Connecticut
VA Connecticut Healthcare System
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
Yale University
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Responsible Party: Patrick D. Skosnik, Assistant Professor, Yale University
ClinicalTrials.gov Identifier: NCT01853020    
Other Study ID Numbers: 1211011055
First Posted: May 14, 2013    Key Record Dates
Last Update Posted: December 2, 2019
Last Verified: November 2019
Keywords provided by Patrick D. Skosnik, Yale University:
Cannabinoids
Eyeblink Conditioning
EBC
Additional relevant MeSH terms:
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Mental Disorders
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders