Impact of OnabotulinumtoxinA (BOTOX®) on Stress

Summary

The purpose of this prospective single-center, blinded\*, randomized, proof-of-concept study is to determine whether OnabotulinumtoxinA (BOTOX®) injections will change the level of stress perceived by generally healthy adult female participants. It is hypothesized that BOTOX® injections will be associated with decreases in perceived stress levels, measured by scores on the Perceived Stress Scale (PSS) questionnaire. The primary outcome measure is a chronological decrease in PSS scores between any two points of the study period. Comparison of the placebo- and BOTOX®-treated participant scores will either support or disprove the study hypothesis. Qualified participants who meet the study requirements, including a one-time completion of basic laboratory testing before treatment. The treatment visit starts on day-1 of a 12-week period, which consists a total of four clinic visits and one online visit, which involve: * vital signs and Body Mass Index (BMI) measurements * basic/interval history and physical * 2 Perceived Stress Scale (PSS) questionnaires * injection of 64 units of either BOTOX® or sterile salt solution * stay for 60-minutes after treatment for monitoring and to complete study tasks

Timeline

Start

2025-03-19

Primary completion

2025-09-10

Completion

2026-01-10

Publications

• Background Charmandari E, Tsigos C, Chrousos G. Endocrinology of the stress response. Annu Rev Physiol. 2005;67:259-84. doi: 10.1146/annurev.physiol.67.040403.120816.
• Background Kubzansky LD, Bordelois P, Jun HJ, Roberts AL, Cerda M, Bluestone N, Koenen KC. The weight of traumatic stress: a prospective study of posttraumatic stress disorder symptoms and weight status in women. JAMA Psychiatry. 2014 Jan;71(1):44-51. doi: 10.1001/jamapsychiatry.2013.2798.
• Background Hori H, Kim Y. Inflammation and post-traumatic stress disorder. Psychiatry Clin Neurosci. 2019 Apr;73(4):143-153. doi: 10.1111/pcn.12820. Epub 2019 Feb 21.
• Background Zhang L, Pan J, Chen W, Jiang J, Huang J. Chronic stress-induced immune dysregulation in cancer: implications for initiation, progression, metastasis, and treatment. Am J Cancer Res. 2020 May 1;10(5):1294-1307. eCollection 2020.
• Background Umamaheswaran S, Dasari SK, Yang P, Lutgendorf SK, Sood AK. Stress, inflammation, and eicosanoids: an emerging perspective. Cancer Metastasis Rev. 2018 Sep;37(2-3):203-211. doi: 10.1007/s10555-018-9741-1.
• Background Bush NR, Savitz J, Coccia M, Jones-Mason K, Adler N, Boyce WT, Laraia B, Epel E. Maternal Stress During Pregnancy Predicts Infant Infectious and Noninfectious Illness. J Pediatr. 2021 Jan;228:117-125.e2. doi: 10.1016/j.jpeds.2020.08.041. Epub 2020 Aug 19.
• Background Glaser R, Kiecolt-Glaser JK. Stress-induced immune dysfunction: implications for health. Nat Rev Immunol. 2005 Mar;5(3):243-51. doi: 10.1038/nri1571.

Drugs

Indications

No indication recorded.