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Completed

NCT Number: NCT03908320

Menstrual Phase and Smoking Cessation at a State Quitline

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.

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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Arizona

Tucson, Arizona, 85721, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Pregnancy
  • Breastfeeding
  • Contraindications to NRT patch

Treatment and study plan

Menstrual Cycle Timing

Other

Quit date is set to menstrual phase.

NRT Patch

Drug

NRT patch is provided

Cessation Counseling

Behavioral

Cessation counseling is provided

Primary outcomes

  1. Recruitment Feasibility

    Time frame: Week -3

    Average number of participants enrolled per month

  2. Treatment Retention Feasibility

    Time frame: Week 4

    Total number of participants who complete to end of treatment

  3. Follow-up Retention Feasibility

    Time frame: Month 3

    Total number of participants who complete follow-up

  4. Feasibility Menstrual Phase Identification

    Time frame: Week 0

    Total proportion of active participants who have a progesterone level of <2 ng/ml on quit date

Secondary outcomes

  1. Smoking Cessation

    Time frame: Week 4, Month 3

    Biochemically confirmed abstinence

  2. Smoking Cessation

    Time frame: 24 hours, Week 1

    Self-reported abstinence

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Registry information

Official study title

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

Acronym: Project Phase

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 9, 2019
Registry last updated
Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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