NCT01853020

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Dec 2012

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 14, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 7, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 7, 2015

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

2.3 years

First QC Date

March 25, 2013

Last Update Submit

September 16, 2024

Conditions

CannabisPsychotic Disorders

Keywords

CannabinoidsEyeblink ConditioningEBC

Outcome Measures

Primary Outcomes (7)

  • Cerebellum Dependent Associative Learning (% CRs)

    % conditioned responses (CRs) will be measured

    Measured +15 minutes after infusion

  • Cerebellum Dependent Associative Learning (CR Latency)

    conditioned response (CR) Latency will be measured

    Measured +15 minutes after infusion

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

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

    Measured +45 minutes after infusion

  • CANTAB Motor Screening Test (Reaction Time)

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

    Measured +45 minutes after infusion

  • CANTAB Motor Screening Test (Accuracy)

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

    Measured +45 minutes after infusion

  • Paced Finger Tapping (Correct Responses)

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

    Measured +45 minutes after infusion

  • Paced Finger Tapping (Reaction Time)

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

    Measured +45 minutes after infusion

Secondary Outcomes (1)

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

    Baseline; +45, +100, +240 minutes after infusion

Study Arms (2)

THC

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

THCDRUG

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.

THC
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age21 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Hearing deficits
  • Psychiatric or mental disorders
  • Hearing Deficits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Connecticut Healthcare System

West Haven, Connecticut, 06516, United States

Location

MeSH Terms

Conditions

Marijuana AbusePsychotic Disorders

Interventions

Dronabinol

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersSchizophrenia Spectrum and Other Psychotic Disorders

Intervention Hierarchy (Ancestors)

CannabinoidsTerpenesHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2013

First Posted

May 14, 2013

Study Start

December 1, 2012

Primary Completion

April 7, 2015

Study Completion

April 7, 2015

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations

US(1)