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Cannabinoids and Cerebellar-Motor Functioning

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ClinicalTrials.gov Identifier: NCT01853020
Recruitment Status : Active, not recruiting
First Posted : May 14, 2013
Last Update Posted : February 3, 2017
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

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
Study Start Date : December 2012
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

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 (% Conditioned Responses) [ Time Frame: +15 minutes after infusion ]
  2. Grooved Pegboard Motor Task (Reaction Time/Accuracy) [ Time Frame: +55 minutes after infusion ]
  3. CANTAB Motor Screening Test (Reaction Time/Accuracy) [ Time Frame: +55 minutes after infusion ]

Secondary Outcome Measures :
  1. Clinician Administered Dissociative Symptoms Scale (Total Score) [ Time Frame: Baseline; +45, +100, +240 minutes after infusion ]
  2. Visual Analog Scale, a measure of THC intoxication (Total Score) [ Time Frame: Baseline; +45, +100, +240 minutes after infusion ]
    0 being none; 100 being completely

  3. Psychotomimetic States Inventory (Total Score) [ Time Frame: Baseline; +45, +100, +240 minutes after infusion ]


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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
United States, Connecticut
VA Connecticut Healthcare System
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
Yale University

Responsible Party: Patrick D. Skosnik, Assistant Professor, Yale University
ClinicalTrials.gov Identifier: NCT01853020     History of Changes
Other Study ID Numbers: 1211011055
First Posted: May 14, 2013    Key Record Dates
Last Update Posted: February 3, 2017
Last Verified: February 2017

Keywords provided by Patrick D. Skosnik, Yale University:
Cannabinoids
Eyeblink Conditioning
EBC

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs