Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01037608 · ClinicalTrials.gov registry record · Phase 1
Effects of Sativex(Registered Trademark) and Oral THC on Attention, Affect, Working Memory, Reversal Learning, Physiology and Brain Activation
A Phase 1 study, sponsored by National Institute on Drug Abuse (NIDA).
- Completed
- Registry status
- Phase 1
- Development phase
- 108
- Enrollment target
NCT01037608 is a Phase 1 study that has completed, run by National Institute on Drug Abuse (NIDA). The registered enrollment target is 108 participants.
The verdict
NCT01037608, a Phase 1 study, has completed, sponsored by National Institute on Drug Abuse (NIDA).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 108 participants
- Enrollment target
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....
Interventions
- DRUG THC
- DRUG Sativex(Registered Trademark)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2007-05-08 |
| Est. Completion | 2011-12-12 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01037608
The ClinicalTrials.gov registry entry for NCT01037608 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 108 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute on Drug Abuse (NIDA), which has 335 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which THC is the first listed.
NCT01037608 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01037608 about?
NCT01037608 is a clinical study titled "Effects of Sativex(Registered Trademark) and Oral THC on Attention, Affect, Working Memory, Reversal Learning, Physiology and Brain Activation". 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...
What is the current status of trial NCT01037608?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 108 participants. The study started on 2007-05-08. Estimated completion is 2011-12-12.
What interventions are being tested in trial NCT01037608?
The interventions under investigation include: THC (DRUG), Sativex(Registered Trademark) (DRUG).
Who is sponsoring clinical trial NCT01037608?
This trial is sponsored by National Institute on Drug Abuse (NIDA), which has 335 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.