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Effects of Sativex(Registered Trademark) and Oral THC on Attention, Affect, Working Memory, Reversal Learning, Physiology and Brain Activation

NCT01037608 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2017-07-02

No results posted yet for this study

Summary

Background:

* The therapeutic modalities of cannabis have received more research attention recently with the discovery of its ability to stimulate appetite and to provide pain and nausea relief in patients with AIDS, cancer, and multiple sclerosis, among other diseases. Sativex(Registered Trademark), an experimental drug derived from the marijuana plant, contains tetrahydrocannabinol (THC) and cannabidiol (CBD), both of which affect brain activity. Sativex(Registered Trademark) is being tested to determine how and to what extent it affects brain activity.
* Functional magnetic resonance imaging (fMRI) uses magnetic waves to study brain activity. Researchers are interested in using fMRI to study how Sativex(Registered Trademark) affects regional brain activity, including thinking abilities and behavior.

Objectives:

* To study changes in regional brain activity produced by Sativex(Registered Trademark) compared with THC and placebo.
* To determine how Sativex(Registered Trademark) is processed by the body.

Eligibility:

\- Individuals between 18 and 45 years of age who are either current users of cannabis (less than daily) or healthy volunteers who do not use cannabis.

Design:

* The study will involve one training session and five testing sessions on separate days.
* At every session, subjects will receive either THC or placebo capsules and either Sativex(Registered Trademark) or placebo spray.
* Participants will complete a training session in a mock fMRI scanner to adapt to the fMRI scanning environment. In the training session, participants will practice the tests that will track thinking ability, attention, working memory, and other cognitive tasks.
* Participants will have five fMRI scanning sessions with the tests they have practiced previously, and will provide blood, urine, and saliva samples as required by the researchers. Participants will be discharged approximately 12 hours after they arrive for the study sessions....

Conditions

  • Cannabis
  • Dependence
  • Cannabis Abuse
  • Pharmacokinetics
  • fMRI

Interventions

DRUG

Sativex(Registered Trademark)

DRUG

THC

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    lead NIH

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-05-08
Primary Completion
2011-08-15
Completion
2011-12-12

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01037608 on ClinicalTrials.gov