Cannabinoids and Cerebellar-Motor Functioning

• Sponsor: Yale University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01853020
• Collaborator: (none)
• Enrollment: 57
• Location: 1
• Arms: 2
• Actual Duration (Months): 28.2
• Patients Per Site Per Month: 2

Study Details

Study Description

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	Early 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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 57 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: Dec 1, 2012
• Actual Primary Completion Date: Apr 7, 2015
• Actual Study Completion Date: Apr 7, 2015

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Cerebellum Dependent Associative Learning (% CRs) [Measured +15 minutes after infusion]

   % conditioned responses (CRs) will be measured

2. Cerebellum Dependent Associative Learning (CR Latency) [Measured +15 minutes after infusion]

   conditioned response (CR) Latency will be measured

3. 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.

4. 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.

5. CANTAB Motor Screening Test (Accuracy) [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) [Measured +45 minutes after infusion]

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

7. 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.

Secondary Outcome Measures

1. THC intoxication, as measured by the Visual Analog Scale (Total Score) [Baseline; +45, +100, +240 minutes after infusion]

   0 being none; 100 being completely

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 35 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Connecticut Healthcare System	West Haven	Connecticut	United States	06516

Sponsors and Collaborators

• Yale University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Patrick D. Skosnik, Assistant Professor, Yale University
• ClinicalTrials.gov Identifier: NCT01853020
• Other Study ID Numbers: 1211011055
• First Posted: May 14, 2013
• Last Update Posted: Feb 11, 2022
• Last Verified: Jan 1, 2022

• Keywords provided by Patrick D. Skosnik, Assistant Professor, Yale University: Cannabinoids; Eyeblink Conditioning; EBC
• Additional relevant MeSH terms: Mental Disorders; Psychotic Disorders

Study Results

No Results Posted as of Feb 11, 2022