Tolerability of Cannabis in Patients Receiving Concurrent Chemoradiation for Glioblastoma
Stopped early · Phase 1
Conditions studied: Glioblastoma
In brief
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.
Key facts
- Study ID
- NCT03246113
- Run by
- New York State Psychiatric Institute
- People needed
- 1
- Starts
- 2018-03-19
- Expected to finish
- 2019-05-09
- Last updated by the study team
- 2019-08-13
Who can join
Age: 21 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of Glioblastoma requiring standard care chemoradiation of concurrent Temozolomide and 60 Gy of radiation given over 30 treatments
- Age 21-70
- Able to give informed consent, and comply with study procedures
You may not qualify if…
- Meet DSM-V criteria for current major psychiatric illness, such as bipolar disorder, major depression, active suicidal intent, or psychosis that could be exacerbated by the administration of cannabis
- Meet DSM-V criteria for major neurological disorder, such as mild cognitive impairment or neurodegenerative disorders (such as movement disorders, dementia), that could be exacerbated by the administration of cannabis.
- Women who are not practicing an effective form of birth control (condoms, diaphragm, birth control pill, IUD) or currently pregnant.
- Current (weekly) use of cannabis.
- Patients on supplemental oxygen or history of chronic obstructive pulmonary disease (COPD).
- Cardiovascular Disease
- Compromised Immunity
- Patients with a history of substance use disorder other than nicotine, such an opiate use disorder.
Where it is running
- Columbia University Medical Center- Department of Radiation Oncology — New York, New York, United States
- New York State Psychiatric Institute — New York, New York, United States
Full record on ClinicalTrials.gov
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