Menstrual CycleProject PhaseNCT03908320
Menstrual Phase and Smoking Cessation at a State Quitline
A study testing Menstrual Cycle Timing, NRT Patch and Cessation Counseling in people with Menstrual Cycle, run by University of Arizona at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menstrual Cycle
- What is being tested?
- Menstrual Cycle Timing, NRT Patch and Cessation Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2019to 30 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Regular smoking
- Regular, natural menstrual cycles
- Interested in quitting
Who cannot join
- Pregnancy
- Breastfeeding
- Contraindications to NRT patch
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Testing the Feasibility of a Novel Smoking Cessation Intervention by Timing Quit Dates to Menstrual Phase in a Quitline Setting
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.
Read the 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
- Being tested
- Menstrual Cycle Timing, NRT Patch, Cessation Counseling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Menstrual Cycle TimingOther
Quit date is set to menstrual phase.
Menstrual Cycle TimingOther
Menstrual cycle timing of quit date is monitored
NRT PatchDrug
NRT patch is provided
Cessation CounselingBehavioural
Cessation counseling is provided
| Study group | Role | What they receive |
|---|---|---|
| Menstrual Cycle Timing | Experimental | Not described Receives: Other: Menstrual Cycle Timing; Drug: NRT Patch; Behavioral: Cessation Counseling |
| Menstrual Cycle Monitoring | Active comparator | Not described Receives: Other: Menstrual Cycle Timing; Drug: NRT Patch; Behavioral: Cessation Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Feasibility
Average number of participants enrolled per month
Measured: Week -3
Treatment Retention Feasibility
Total number of participants who complete to end of treatment
Measured: Week 4
Follow-up Retention Feasibility
Total number of participants who complete follow-up
Measured: Month 3
Feasibility Menstrual Phase Identification
Total proportion of active participants who have a progesterone level of <2 ng/ml on quit date
Measured: Week 0
Secondary outcomes (2)
Smoking Cessation
Biochemically confirmed abstinence
Measured: Week 4, Month 3
Smoking Cessation
Self-reported abstinence
Measured: 24 hours, Week 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start15 Jan 2019
- Primary completion31 May 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Menstrual CycleStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alicia Allen, PhD, MPH, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03908320
- Sponsor's protocol ID
- 1805561891
- Acronym
- Project Phase
- Status last verified
- Oct 2020
- First submitted
- 28 Mar 2019
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Pending
Publications
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.
PubMed 40214198
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Feasibility of a Novel Smoking Cessation Intervention by Timing Quit Dates to Menstrual Phase in a Quitline Setting
- ClinicalTrials.gov ID
- NCT03908320
- Acronym / sponsor ID
- Project Phase / 1805561891
- Conditions
- Menstrual Cycle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 31 May 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 9 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Menstrual Cycle Timing | Experimental | Other: Menstrual Cycle Timing, Drug: NRT Patch, Behavioral: Cessation Counseling |
| Menstrual Cycle Monitoring | Active comparator | Other: Menstrual Cycle Timing, Drug: NRT Patch, Behavioral: Cessation Counseling |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Regular smoking
- Regular, natural menstrual cycles
- Interested in quitting
Key exclusion criteria (3 listed)
- Pregnancy
- Breastfeeding
- Contraindications to NRT patch
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Menstrual Cycle TimingQuit date is set to menstrual phase. | Other | Menstrual Cycle Timing |
| Menstrual Cycle TimingMenstrual cycle timing of quit date is monitored | Other | Menstrual Cycle Monitoring |
| NRT PatchNRT patch is provided | Drug | Menstrual Cycle Monitoring, Menstrual Cycle Timing |
| Cessation CounselingCessation counseling is provided | Behavioural | Menstrual Cycle Monitoring, Menstrual Cycle Timing |
Primary outcome
Recruitment Feasibility
Time frame: Week -3
Average number of participants enrolled per month
Treatment Retention Feasibility
Time frame: Week 4
Total number of participants who complete to end of treatment
Follow-up Retention Feasibility
Time frame: Month 3
Total number of participants who complete follow-up
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
2 secondary outcomes
Smoking Cessation
Time frame: Week 4, Month 3
Smoking Cessation
Time frame: 24 hours, Week 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Derived from this study: PubMed 40214198Chalke 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.
- Individual participant dataSharing planned: No. Pending
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Menstrual Cycle Timing, NRT Patch and Cessation Counseling in people with Menstrual Cycle, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Feasibility (time frame: Week -3). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03908320, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.