NCT02675842

Investigation of Cannabis for Pain and Inflammation in Lung Cancer

Withdrawn Phase 1 Last updated 1 November 2021

What this trial tests

Phase 1 trial testing Smoked Cannabis High CBD/low THC in Lung Cancer. Withdrawn.

Timeline

Primary endpoint
28 October 2021

28 October 2021

Quick facts

Lead sponsor	New York State Psychiatric Institute
Phase	Phase 1
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
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

• Lung Cancer — all drugs for Lung Cancer →

Sponsor

New York State Psychiatric Institute

Who can join

Adults 21 to 60, any sex, with Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Radiation therapy to the chest is used in late stage lung cancer, and it often leads to inflammation of the esophagus. The inflammation is expected to occur in about 75% of patient, and usually begin within a week of starting radiation therapy. The esophagitis causes pain and difficulty eating. It can also result in stopping or delaying treatment.Radiation therapy to the chest is used in late stage lung cancer, and it often leads to inflammation of the esophagus. The inflammation is expected to occur in about 75% of patient, and usually begin within a week of starting radiation therapy. The esophagitis causes pain and difficulty eating. The endocannabinoid system is prominent in the gastrointestinal system, and cannabis has been shown to greatly inhibit inflammation. The compound (-)-trans-Δ9-tetrahydrocannabinol (Δ-9-THC) has effects that reduce inflammation and pain. Cannabidiol is a component of cannabis that does not produce subjective or intoxicating effects, but also has prominent anti-inflammatory properties.

The goal of this study is to perform a double-blind, placebo-controlled study to investigate the efficacy of cannabis, compared to placebo, in participants undergoing RT (Radiation Therapy) for lung cancer. Cannabis that has a high concentration of cannabidiol will be used , which is a cannabinoid that does not change perception or produce intoxication, and low in Δ-9-THC. In this way, the hope is to maximize the benefit of cannabis, while lowering the possible side effects of cannabis in medically ill participants.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cannabinoids as anticancer therapeutic agents.
   Kovalchuk O, Kovalchuk I. · · 2020 · cited 53× · PMID 32249682 · DOI 10.1080/15384101.2020.1742952
2. A user's guide to cannabinoid therapies in oncology.
   Maida V, Daeninck PJ. · · 2016 · cited 45× · PMID 28050136 · DOI 10.3747/co.23.3487
3. Cannabidiol on the Path from the Lab to the Cancer Patient: Opportunities and Challenges.
   Olivas-Aguirre M, Torres-López L, Villatoro-Gómez K, Perez-Tapia SM, et al · · 2022 · cited 16× · PMID 35337163 · DOI 10.3390/ph15030366
4. Psychedelics for Cancer Pain and Associated Psychological Distress: A Narrative Review of a Potential Strategy.
   Belitzky E, Ravani Carvalho LV, Taylor M, Ortiz CN, et al · · 2025 · cited 1× · PMID 40052631 · DOI 10.1002/cam4.70586
5. ACPA prevents lung fibroblast-to-CAF transformation by reprogramming the tumor microenvironment through NSCLC-derived exosomes.
   Boyacıoğlu Ö, Kalali BD, Reçber T, Gelen-Gungor D, et al · · 2025 · PMID 41315832 · DOI 10.1038/s41598-025-29726-4