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NCT02683018
Investigation of Cannabis for Chronic Pain and Palliative Care
Phase 1 trial testing Smoked Cannabis High CBD/low THC in Chronic Pain. Withdrawn.
28 October 2021
Quick facts
| Lead sponsor | New York State Psychiatric Institute |
|---|---|
| Phase | Phase 1 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | double |
| Primary purpose | treatment |
| Primary completion | 28 October 2021 |
| Estimated completion | 28 October 2021 |
Drugs / interventions tested
- Smoked Cannabis High CBD/low THC — full drug profile →
- Smoked Placebo Cannabis Low CBD/low THC — full drug profile →
Conditions studied
- Chronic Pain — all drugs for Chronic Pain →
Sponsor
New York State Psychiatric Institute
Who can join
Adults 21 to 60, any sex, with Chronic Pain. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The use of cannabis for severe medical conditions is being legalized in different states, increasing the mandate to make cannabis legal for medically ill patients. However, there is a lack of placebo-controlled studies investigating the efficacy of cannabis. Dronabinol (synthetic, oral Δ-9-THC) is FDA approved for the appetite stimulation in AIDS-related anorexia and nausea/vomiting in chemotherapy patients. Nabilone, a synthetic analogue of THC, is approved for nausea/vomiting in chemotherapy patients. These medications have been found to be effective for these disorders, but there remains an interest in studying cannabis, partly due to the numerous cannabinoids contained within the cannabis plant. Among these is cannabidiol, which does not produce subjective effects, but has been shown to have potent anti-inflammatory effects. In addition, there is data indicating that cannabidiol may be effective for neuropathic pain and nausea/vomiting. The goal is to investigate the effects of high CBD/low THC cannabis on symptoms such as pain, nausea/vomiting, and quality of life in seriously ill participants. While there is data beginning to emerge that cannabis may have a beneficial effect on these symptoms, there are few placebo controlled, double-blind studies. Additionally, the administration of cannabis to medically ill patients may be limited by its subjective effects, such as anxiety, intoxication, or paranoia. Most cannabis available today has high levels of Δ-9-THC (about 15%). By using cannabis that is high in CBD, but low in - Δ-9-THC, it is hypothesized that some of these effects can be avoid, while maximizing the therapeutic effects, if any.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT02683018
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Smoked Cannabis High CBD/low THC
Trials testing the same drug.
- NCT02675842 — Investigation of Cannabis for Pain and Inflammation in Lung Cancer · Phase 1 · withdrawn
Other recruiting trials for Chronic Pain
Currently open trials in the same condition.
- NCT07491549 — The Effect of Pain Education Group Therapy and Its Impact on Chronic Pain, Kinesiophobia, and Physical Activity · NA · recruiting
- NCT07425691 — SPACE for Youth With Chronic Pain · recruiting
- NCT07103135 — Optimizing Accelerated TMS for Chronic Pain With Thompson Sampling · Phase 1 · recruiting
- NCT06219408 — CIH Stepped Care for Co-occurring Chronic Pain and PTSD · NA · recruiting
- NCT07270406 — Healthy Behaviors for Insomnia Prevention in People With HIV and Ongoing Pain · NA · recruiting
Other New York State Psychiatric Institute trials
Trials by the same sponsor.
- NCT05416658 — Shared Decision Making for Antipsychotic Medications · NA · not yet recruiting
- NCT07423546 — A PET/MRI Study of Cobenfy on Dopamine Transmission in Schizophrenia · Phase 1, PHASE2 · not yet recruiting
- NCT05339256 — Sublingual Buprenorphine Through Telemedicine vs In-Person Care as Usual · Phase 2 · not yet recruiting
- NCT05563948 — Repeated Administration of Cannabis Varying in THC and CBD · Phase 2 · suspended
- NCT06977308 — A Multimodal Imaging Study of Dopamine in Early Psychosis · Phase 1 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02683018 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by New York State Psychiatric Institute
- Last refreshed: 1 November 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02683018.
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