Menstrual Phase and Smoking Cessation at a State Quitline

Menstrual Cycle Clinical Trial

— Project Phase  

Official title:

Testing the Feasibility of a Novel Smoking Cessation Intervention by Timing Quit Dates to Menstrual Phase in a Quitline Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03908320
• Other study ID #: 1805561891
• Status: Completed
• Phase: N/A
• Start date: January 15, 2019
• Est. completion date: September 30, 2020

Study information

• Verified date: October 2020
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: September 30, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Regular smoking

• Regular, natural menstrual cycles

• Interested in quitting

Exclusion Criteria:

• Pregnancy

• Breastfeeding

• Contraindications to NRT patch

Related Conditions & MeSH terms

• Menstrual Cycle

Intervention

Other:
• Menstrual Cycle Timing
Quit date is set to menstrual phase.
• Menstrual Cycle Timing
Menstrual cycle timing of quit date is monitored

Drug:
• NRT Patch
NRT patch is provided

Behavioral:
• Cessation Counseling
Cessation counseling is provided

Locations

Country	Name	City	State
United States	University of Arizona	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment Feasibility	Average number of participants enrolled per month	Week -3
Primary	Treatment Retention Feasibility	Total number of participants who complete to end of treatment	Week 4
Primary	Follow-up Retention Feasibility	Total number of participants who complete follow-up	Month 3
Primary	Feasibility Menstrual Phase Identification	Total proportion of active participants who have a progesterone level of <2 ng/ml on quit date	Week 0
Secondary	Smoking Cessation	Biochemically confirmed abstinence	Week 4, Month 3
Secondary	Smoking Cessation	Self-reported abstinence	24 hours, Week 1