Last reviewed · How we verify

NCT02683018

Investigation of Cannabis for Chronic Pain and Palliative Care

Withdrawn Phase 1 Last updated 1 November 2021
What this trial tests

Phase 1 trial testing Smoked Cannabis High CBD/low THC in Chronic Pain. Withdrawn.

Timeline
Primary endpoint
28 October 2021
28 October 2021

Quick facts

Lead sponsorNew York State Psychiatric Institute
PhasePhase 1
StatusWithdrawn
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingdouble
Primary purposetreatment
Primary completion28 October 2021
Estimated completion28 October 2021

Drugs / interventions tested

Conditions studied

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:

Other trials of Smoked Cannabis High CBD/low THC

Trials testing the same drug.

Other recruiting trials for Chronic Pain

Currently open trials in the same condition.

Other New York State Psychiatric Institute trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing