NCT00628706

Brief Summary

The purpose of this study is to determine whether THC, the main psychoactive ingredient in cannabis, affects functional brain systems underlying memory and reward.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Apr 2008

Shorter than P25 for 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

First Submitted

Initial submission to the registry

February 24, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 5, 2008

Completed
27 days until next milestone

Study Start

First participant enrolled

April 1, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

February 18, 2009

Status Verified

February 1, 2009

Enrollment Period

5 months

First QC Date

February 24, 2008

Last Update Submit

February 17, 2009

Conditions

RewardTetrahydrocannabinolEndocannabinoidsMemoryMagnetic Resonance Imaging

Keywords

tetrahydrocannabinolmemoryrewardmagnetic resonance imagingendocannabinoids

Outcome Measures

Primary Outcomes (1)

  • The main study parameter is the blood oxygen level dependent (BOLD) signal.

    4 months

Secondary Outcomes (4)

  • Behavioral parameters (two VAS questionnaires)

    4 months

  • Cerebral blood flow (ASL)

    4 months

  • Concentration of plasma THC and its main metabolites

    4 months

  • Performance on neuropsychological tests

    4 months

Study Arms (2)

A

EXPERIMENTAL

Inhalation of THC, using a Volcano vaporizer

Drug: Delta9-tetrahydrocannabinol (THC)

B

PLACEBO COMPARATOR

Inhalation of vehicle, using a Volcano vaporizer

Drug: Delta9-tetrahydrocannabinol (THC)

Interventions

Delta9-tetrahydrocannabinol (THC)DRUG

inhalation of 6 mg liquid THC, vaporized by means of a Volcano vaporizer

Also known as: dronabinol, marinol, THC, tetrahydrocannabinol
AB

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • History of mild cannabis use for at least one year (\<1/week and ≥ 4/year)
  • History without psychotic experiences after cannabis use
  • Age between 18 and 45 years
  • Right-handedness, assessed with the Edinburgh Handedness Inventory
  • Written informed consent of the subject

You may not qualify if:

  • Any clinical significant abnormality of any clinical laboratory test, including urinary drug screening
  • Impaired physical health evaluated by medical history, physical (including neurological) examination and screening laboratory tests
  • History of clinically significant psychiatric or neurological illness
  • History of clinically significant psychiatric or neurological illness in first- or second-degree relatives
  • History of alcohol and/or drug abuse (DSM-IV criteria)
  • Body Mass Index (B.M.I.) \<18 kg/m2 or \>28 kg/m2
  • Paranoid ideation or psychoticism on SCL-90
  • Any subject who received any investigational medication within 90 days prior to the start of the study or who is scheduled to receive an investigational drug
  • The use of any medication within three weeks prior to the start of the study, except for paracetamol
  • Positive HIV or Hepatitis B/C test
  • Blood donation within 3 months before the start of the study
  • Claustrophobia
  • Metal objects in or around the body (braces, pacemaker, metal fragments)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Utrecht

Utrecht, 3584CX, Netherlands

Location

Related Publications (1)

  • Bossong MG, Jager G, van Hell HH, Zuurman L, Jansma JM, Mehta MA, van Gerven JM, Kahn RS, Ramsey NF. Effects of Delta9-tetrahydrocannabinol administration on human encoding and recall memory function: a pharmacological FMRI study. J Cogn Neurosci. 2012 Mar;24(3):588-99. doi: 10.1162/jocn_a_00156. Epub 2011 Nov 8.

    PMID: 22066583DERIVED

MeSH Terms

Interventions

Dronabinol

Intervention Hierarchy (Ancestors)

CannabinoidsTerpenesHydrocarbonsOrganic Chemicals

Study Officials

  • Nick Ramsey, Professor

    UMC Utrecht

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 24, 2008

First Posted

March 5, 2008

Study Start

April 1, 2008

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

February 18, 2009

Record last verified: 2009-02

Locations

NL(1)