Menstrual Phase and Smoking Cessation at a State Quitline
Project Phase
Testing the Feasibility of a Novel Smoking Cessation Intervention by Timing Quit Dates to Menstrual Phase in a Quitline Setting
1 other identifier
interventional
119
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 15, 2019
CompletedFirst Submitted
Initial submission to the registry
March 28, 2019
CompletedFirst Posted
Study publicly available on registry
April 9, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2020
CompletedOctober 19, 2020
October 1, 2020
1.4 years
March 28, 2019
October 15, 2020
Conditions
Outcome Measures
Primary Outcomes (4)
Recruitment Feasibility
Average number of participants enrolled per month
Week -3
Treatment Retention Feasibility
Total number of participants who complete to end of treatment
Week 4
Follow-up Retention Feasibility
Total number of participants who complete follow-up
Month 3
Feasibility Menstrual Phase Identification
Total proportion of active participants who have a progesterone level of \<2 ng/ml on quit date
Week 0
Secondary Outcomes (2)
Smoking Cessation
Week 4, Month 3
Smoking Cessation
24 hours, Week 1
Study Arms (2)
Menstrual Cycle Timing
EXPERIMENTALMenstrual Cycle Monitoring
ACTIVE COMPARATORInterventions
Cessation counseling is provided
Eligibility Criteria
You may qualify if:
- Regular smoking
- Regular, natural menstrual cycles
- Interested in quitting
You may not qualify if:
- Pregnancy
- Breastfeeding
- Contraindications to NRT patch
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Arizona
Tucson, Arizona, 85721, United States
Related Publications (1)
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.
PMID: 40214198DERIVED
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
March 28, 2019
First Posted
April 9, 2019
Study Start
January 15, 2019
Primary Completion
May 31, 2020
Study Completion
September 30, 2020
Last Updated
October 19, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share
Pending