NCT00285051

Study to Compare the Safety and Efficacy of 2 Different Doses of Inhaled D8-THC to Standard Therapy With Ondansetron in the Prevention of Acute Nausea From Moderately Emetogenic Chemotherapy

Terminated Phase 2 Last updated 20 December 2020

What this trial tests

Phase 2 trial testing inhaled delta-8-THC 300mcg or 600mcg per dose in Cancer in 6 participants. Terminated before completion.

Timeline

1 November 2005

Primary endpoint
1 February 2009

1 February 2009

Quick facts

Lead sponsor	Rafa Laboratories
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	triple
Primary purpose	treatment
Enrollment	6
Start date	1 November 2005
Primary completion	1 February 2009
Estimated completion	1 February 2009
Sites	2 locations across Israel

Drugs / interventions tested

• inhaled delta-8-THC 300mcg or 600mcg per dose — full drug profile →

Conditions studied

• Cancer — all drugs for Cancer →

Sponsor

Rafa Laboratories — full company profile →

Who can join

Adults 18 to 85, any sex, with Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• VAS scale for nausea
  Time frame: Up to 4 days after the patient receives chemotherapy. Measurements taken just before and 2 hours after inhalation morning and evening doses.
  subjective measurement of feeling of nausea. Patients to indicate on a horizontal line, how much nausea the patient feels, lower score = less nausea, higher score is more severe. Measurement is made on the line from "none" to "severe" for score.

Sponsor's own description

Patients will be treated for 2 consecutive chemo cycles with the study drug for one and placebo for the other. In addition, patients will receive an injection before the chemo, either ondansetron (if receiving placebo inhalation) or normal saline) if receiving active study drug. They will take study medication for 3 days, 4 times daily and fill out VAS scores before and after doses. Patients will be given rescue medication with each dose.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The Development of Cannabinoids as Therapeutic Agents in the United States.
   Murray CH, Gannon BM, Winsauer PJ, Cooper ZD, et al · · 2024 · cited 7× · PMID 38849155 · DOI 10.1124/pharmrev.123.001121