Menstrual Phase and Smoking Cessation at a State Quitline

NCT ID: NCT03908320

Last Updated: 2020-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 119 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-15
• Study Completion Date: 2020-09-30

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.

Conditions

Menstrual Cycle

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Menstrual Cycle Timing

Group Type: EXPERIMENTAL

Menstrual Cycle Timing

Intervention Type: OTHER

Quit date is set to menstrual phase.

NRT Patch

Intervention Type: DRUG

NRT patch is provided

Cessation Counseling

Intervention Type: BEHAVIORAL

Cessation counseling is provided

Menstrual Cycle Monitoring

Group Type: ACTIVE_COMPARATOR

Menstrual Cycle Timing

Intervention Type: OTHER

Menstrual cycle timing of quit date is monitored

NRT Patch

Intervention Type: DRUG

NRT patch is provided

Cessation Counseling

Intervention Type: BEHAVIORAL

Cessation counseling is provided

Interventions

Menstrual Cycle Timing

Quit date is set to menstrual phase.

Intervention Type: OTHER

Menstrual Cycle Timing

Menstrual cycle timing of quit date is monitored

Intervention Type: OTHER

NRT Patch

NRT patch is provided

Intervention Type: DRUG

Cessation Counseling

Cessation counseling is provided

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Pregnancy
• Breastfeeding
• Contraindications to NRT patch

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Arizona

OTHER

Sponsor Role: lead

Responsible Party

Alicia Allen, PhD, MPH

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Arizona

Tucson, Arizona, United States

Countries

United States

References

Chalke AM, Linde-Krieger LB, Allen AM, Nair US. Urge Coping Mediates the Relationship Between Physical Activity and Smoking Outcomes in a Sample of Premenopausal Women Intending to Quit Smoking. Nicotine Tob Res. 2025 Oct 22;27(11):2086-2096. doi: 10.1093/ntr/ntaf081.

Reference Type: DERIVED

PMID: 40214198 (View on PubMed)

Other Identifiers

1805561891

Identifier Type: -

Identifier Source: org_study_id