Menstrual Phase and Smoking Cessation at a State Quitline

Not Applicable

Completed

• Conditions: Menstrual Cycle
• Interventions: Other: Menstrual Cycle Timing; Drug: NRT Patch; Behavioral: Cessation Counseling

• Registration Number: NCT03908320
• Lead Sponsor: University of Arizona

Brief Summary

Quitlines are efficient and cost-effective treatments for smoking cessation, yet little research has explored how to personalize and optimize quitline services for women. The goal of this project is to explore the feasibility and preliminary efficacy of a quitline intervention that considers the menstrual cycle as compared to standard care for cessation. If funded, the results of this study will directly inform future research on quitline smoking cessation interventions for premenopausal women, including a full scale clinical trial.

Detailed Description

Although more than 75% of women who smoke want to quit, they do not have the same success that men have. This is of particular concern as premenopausal women smokers are more likely to experience smoking-related morbidity and mortality than men smokers. Further, mothers are the primary source of secondhand smoke exposure in children. Quitlines are broad reaching, cost-effective programs that disseminate smoking cessation treatment; however, little research has focused on tailoring quitline programs for women. The goal of this study is to investigate how the quit interventions can be informed by the menstrual cycle to improve cessation outcomes in women. This study will enroll 116 women between 18-40 years of age from the Arizona Smokers' Helpline. Menstrual phase identification will be determined using methods from published recommendations. Consistent with existing quitline protocols, participants will receive 4-weeks of NRT (patch) concurrent with six-weeks of telephone-based behavioral coaching. Data will be collected at Baseline, Week 0 (quit day), Week 1, Week 4 (end of treatment), and a follow-up at Month 3 using telephone interviews, validated questionnaires, and dried blood spots (to measure sex hormones to verify menstrual phase and cotinine to verify smoking status). Primary outcomes include determining acceptability and feasibility of this menstrual-cycle based intervention (recruitment and retention rate, the ability to correctly identify the menstrual phase, and overall participant study satisfaction). Smoking cessation outcomes (self-report and/or biochemically verified) will be assessed at Week 1, Week 4 (end of treatment), and at Month 3 follow-up. Finally, we will explore menstrual phase differences in theoretically-relevant factors known to be associated with smoking cessation (e.g., social support, weight concerns, urge coping). Study results will guide protocol development and generate hypotheses for larger-scaled randomized controlled trials. This study is novel and pragmatic, integrating emerging evidence for the role of menstrual-cycle timed quit dates with state-of-the-science quitline cessation programs. If successful, this model can be cost-effectively replicated within state and national quitline programs. It can address the unique barriers to smoking behavior change among premenopausal women, increase successful quit outcomes and reduce disease risk associated with high tobacco-related morbidity rates.

Study Timeline

• Study Start: 2019-01-15
• Study First Submitted: 2019-03-28
• Study First Submitted QC: 2019-04-05
• Study First Posted: 2019-04-09
• Primary Completion: 2020-05-31
• Study Completion: 2020-09-30
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-15
• Last Update Posted: 2020-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 119

Inclusion Criteria

• Regular smoking
• Regular, natural menstrual cycles
• Interested in quitting

Exclusion Criteria

• Pregnancy
• Breastfeeding
• Contraindications to NRT patch

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Menstrual Cycle Timing	Cessation Counseling	-
Menstrual Cycle Monitoring	NRT Patch	-
Menstrual Cycle Monitoring	Cessation Counseling	-
Menstrual Cycle Monitoring	Menstrual Cycle Timing	-
Menstrual Cycle Timing	Menstrual Cycle Timing	-
Menstrual Cycle Timing	NRT Patch	-

Primary Outcome Measures

Name	Time	Method
Recruitment Feasibility	Week -3	Average number of participants enrolled per month
Treatment Retention Feasibility	Week 4	Total number of participants who complete to end of treatment
Feasibility Menstrual Phase Identification	Week 0	Total proportion of active participants who have a progesterone level of \<2 ng/ml on quit date
Follow-up Retention Feasibility	Month 3	Total number of participants who complete follow-up

Secondary Outcome Measures

Name	Time	Method
Smoking Cessation	24 hours, Week 1	Self-reported abstinence

Trial Locations

Locations (1)

University of Arizona; 🇺🇸 Tucson, Arizona, United States