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NCT03246113 · ClinicalTrials.gov registry record · Phase 1
Tolerability of Cannabis in Patients Receiving Concurrent Chemoradiation for Glioblastoma
A Phase 1 study, sponsored by New York State Psychiatric Institute.
- Terminated
- Registry status
- Phase 1
- Development phase
- 1
- Enrollment target
NCT03246113: Clinical Trial Phase 1 study, sponsored by New York State Psychiatric Institute.
NCT03246113 is a Phase 1 study that was terminated before completion, run by New York State Psychiatric Institute. The registered enrollment target is 1 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03246113, a Phase 1 study, was terminated before completion, sponsored by New York State Psychiatric Institute.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 1 participants
- Enrollment target
Study Summary
The goal of this single arm Phase I feasibility study is to investigate the tolerability of cannabis with concurrent chemoradiation in the treatment of glioblastoma multiforme (GBM). A strain of cannabis provided by The National Institute of Drug Abuse (NIDA) that has a high concentration of cannabidiol (CBD) and a low concentration of THC (relative to average street cannabis) will be tested in order to maximize clinical efficacy while minimizing intoxicating side effects in this medically-ill population.
Primary Outcome
Number of cannabis-related adverse events A 44-item computerized subjective-effects questionnaire visual analog scale (VAS), comprising a series of 100-mm lines labeled 'not at all' (0 mm) at one end and 'extremely' at the other end, will be completed at baseline, after the 90 minutes of cannabis availability and at the end of the session. The VAS included mood, physical symptom, and drug effect descriptors; participants will be instructed to rate the extent to which each descriptor applied to
Interventions
- RADIATION Radiation Therapy
- DRUG Temozolomide
- DRUG Cannabis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2018-03-19 |
| Est. Completion | 2019-05-09 |
| Phase | Phase 1 |
Why NCT03246113 stopped before completion
NCT03246113 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 3 interventions - of which Radiation Therapy is the first listed.
NCT03246113 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03246113 about?
NCT03246113 is a clinical study titled "Tolerability of Cannabis in Patients Receiving Concurrent Chemoradiation for Glioblastoma". The goal of this single arm Phase I feasibility study is to investigate the tolerability of cannabis with concurrent chemoradiation in the treatment of glioblastoma multiforme (GBM). A strain of cannabis provided by The National Institute of Drug Abuse (NIDA) that has a high concentration of cannabi...
What is the current status of trial NCT03246113?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2018-03-19. Estimated completion is 2019-05-09.
What interventions are being tested in trial NCT03246113?
The interventions under investigation include: Radiation Therapy (RADIATION), Temozolomide (DRUG), Cannabis (DRUG).
Who is sponsoring clinical trial NCT03246113?
This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03246113's enrollment target sits among peer trials
1 2001st of 2000 the lowest 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
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