Feasibility and acceptability of testing a menstrual-cycle timed smoking cessation intervention for women of reproductive age (Project Phase): Protocol of a pilot randomized controlled trial

• Main Authors: Uma S. Nair, Elizabeth S. Miller, Melanie L. Bell, Sharon Allen, Bradley N. Collins, Alicia M. Allen
• Format: Article
• Language: English
• Published: Elsevier 2020-06-01
• Series: Contemporary Clinical Trials Communications
• Subjects: Smoking cessation; Women; Menstrual cycle; Telephone-based interventions
• Online Access: http://www.sciencedirect.com/science/article/pii/S2451865420300533

Background: Compared to men, women have unique barriers to smoking cessation and are less likely to utilize quitline services. While current clinical recommendations have called for sex/gender-specific smoking cessation protocols, quitlines have not been expanded protocols to address the unique needs of women. Menstrual cycles (and/or ovarian hormones) influence quit outcomes in women. This paper presents the study design and protocol for a randomized control trial (Project Phase) designed to test the feasibility and acceptability of utilizing menstrual cycle timing to improve quit outcomes in women of reproductive age. Methods/design: Participants include treatment-seeking women (n = 116), between the ages of 18–40 with regular and naturally-occurring menstrual cycles. Eligible participants are randomized to either the mid-Follicular Phase (FP) or Standard Care (SC-control) group. Counseling includes six weekly telephone sessions with four weeks of nicotine replacement therapy. The timing and frequency of sessions is identical to both conditions, with the exception of the quit day (week 3 of counseling). In addition to providing education on menstrual cycle and quitting, quit day for FP participants is set within 6–8 days post onset of menses; the SC group quit day is set for Week 3 of counseling regardless of their menstrual cycle phase. Dried blood spots will be used to bioverify menstrual cycle phase and smoking status. Discussion: If feasible and acceptable, our behavioral counseling intervention that times the quit day to the mid-follicular phase of the menstrual may increase quit outcomes among women of reproductive age and has potential for dissemination across quitlines nationally.