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Cannabinoids and Cerebellar-Motor Functioning

Primary Purpose

Cannabis, Psychotic Disorders

Status

Completed

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

THC

Placebo

About this trial

This is an interventional other trial for Cannabis focused on measuring Cannabinoids, Eyeblink Conditioning, EBC

Eligibility Criteria

21 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

VA Connecticut Healthcare System

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

THC

Placebo

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Cerebellum Dependent Associative Learning (% CRs)

% conditioned responses (CRs) will be measured

Cerebellum Dependent Associative Learning (CR Latency)

conditioned response (CR) Latency will be measured

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

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

CANTAB Motor Screening Test (Reaction Time)

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

CANTAB Motor Screening Test (Accuracy)

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

Paced Finger Tapping (Correct Responses)

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

Paced Finger Tapping (Reaction Time)

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

Secondary Outcome Measures

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

0 being none; 100 being completely

Full Information

NCT ID

NCT01853020

First Posted

March 25, 2013

Last Updated

January 27, 2022

Sponsor

Yale University

1. Study Identification

Unique Protocol Identification Number

NCT01853020

Brief Title

Cannabinoids and Cerebellar-Motor Functioning

Official Title

Cannabinoids and Cerebellar-Motor Functioning

Study Type

Interventional

2. Study Status

Record Verification Date

January 2022

Overall Recruitment Status

Completed

Study Start Date

December 2012 (Actual)

Primary Completion Date

April 7, 2015 (Actual)

Study Completion Date

April 7, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Yale University

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cannabis, Psychotic Disorders

Keywords

Cannabinoids, Eyeblink Conditioning, EBC

7. Study Design

Primary Purpose

Other

Study Phase

Early Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

57 (Actual)

8. Arms, Groups, and Interventions

Arm Title

THC

Arm Type

Active Comparator

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

THC

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Cerebellum Dependent Associative Learning (% CRs)

Description

% conditioned responses (CRs) will be measured

Time Frame

Measured +15 minutes after infusion

Title

Cerebellum Dependent Associative Learning (CR Latency)

Description

conditioned response (CR) Latency will be measured

Time Frame

Measured +15 minutes after infusion

Title

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

Description

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

Time Frame