Cannabinoids and Cerebellar-Motor Functioning

Yale University

Status and phase: Completed; Early Phase 1

Conditions: Psychotic Disorders; Cannabis

Treatments: Drug: Placebo; Drug: THC

Study type: Interventional

Funder types: Other

Identifiers

NCT01853020

1211011055

Details and patient eligibility

About

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.

Full 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).

Enrollment: 57 patients

Sex: All

Ages: 21 to 35 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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57 participants in 2 patient groups, including a placebo group

THC

Active Comparator group

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.

Treatment:

Drug: THC

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo