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: Completed Phase 1 study, sponsored by National Institute on Drug Abuse (NIDA).
NCT01037608 is a Phase 1 study that has completed, run by National Institute on Drug Abuse (NIDA). The registered enrollment target is 108 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% higher). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT01037608 record still lists
NCT01037608 is an interventional study that assigns participants to a tested intervention. The registered 108 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% higher).
The record links to 0 conditions, and to 2 interventions - of which THC is the first listed.
NCT01037608 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT01037608's enrollment target sits among peer trials
108 523rd of 2000 higher than 1,470 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02703207 · 108 participants · NA
Neurocognitive and Health Impact of Sleep Apnea in Elderly Veterans With Comorbid COPD
- NCT02744677 · 108 participants · NA
COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction
- NCT02781883 · 108 participants · Phase 2
Clinical Trial of BP1001 in Combination With With Venetoclax Plus Decitabine in AML
- NCT03848663 · 108 participants · NA
Visual Remapping to Aid Reading With Field Loss
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI