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

Introduction: Menstrual phase influences cigarette smoking-related outcomes. Telephone-based cessation programs (e.g., quitlines) may incorporate the role of the menstrual cycle in an effort to tailor interventions for women. Purpose: The goal of this preliminary randomized clinical trial was to examine the feasibility and acceptability of timing quit date to menstrual phase in women in a quitline setting. Methods: We recruited treatment-seeking women with regular menstrual cycles between the ages of 18–40 years. Participants were randomized to the follicular phase (FP; quit date set 6–8 days post onset of menses) or standard of care (SC; no menstrual timing of quit date). All participants received four weeks of nicotine replacement therapy transdermal patch concurrent with six weeks of telephone-based counseling. We explored self-reported and biochemically-verified seven-day point prevalence abstinence at end-of-treatment and three-month follow-up. Results: Participants (n = 119; FP: n = 58, SC: n = 61) were, on average, 33.4 years old and smoked 13.6 cigarettes/day. The median number of counseling sessions completed was 6 out of 6 available, and 66% of participants completed the intervention. Over 90% of participants reported they would recommend this study to friends/family. Cessation rates did not significantly vary by randomization. Conclusions: Results of this preliminary trial indicate that timing quit date to FP is an acceptable and feasible approach to address smoking cessation in women of reproductive age. While we observed similar smoking cessation rates between groups, this preliminary study was not fully powered to determine efficacy. Therefore, the feasibility and acceptability results indicate that a fully-powered efficacy trial is warranted.