RCT of CBD for Anxiety in Advanced Breast Cancer

Phase 2 Active not recruiting 60 enrolled Dana-Farber Cancer Institute Hans and Mavis Lopater Foundation · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

This research study is investigating use of a single dose of cannabidiol (CBD) to help manage anticipatory anxiety in participants with advanced breast cancer poised to undergo computed tomography (CT) or positron emission tomography (PET) to assess tumor burden. The name of the study drug(s) are: \- Cannabidiol (CBD)

Timeline

Start: 2022-01-19
Primary completion: 2023-03-01
Completion: 2026-12-01

Outcome

Missed primary endpoint

paper The primary end point of VAMS afraid subscale change score, although numerically greater in the CBD arm, was not significantly different between arms PMID 39680411 ↗

paper Although the study did not meet its primary end point comparing preingestion vs postingestion anxiety change scores between study arms PMID 39680411 ↗

Publications

Nayak MM, Chai P, Catalano PJ, Pirl WF, Tulsky JA, Tung SC, Lin NU, Andrade N, Johns S, Vaz C, Hughes M, Braun IM. Cannabidiol for Scan-Related Anxiety in Women With Advanced Breast Cancer: A Randomized Clinical Trial. JAMA Netw Open. 2024 Dec 2;7(12):e2450391. doi: 10.1001/jamanetworkopen.2024.50391.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cannabidiol	Other / unclassified	400 mg	Oral