Nicotine DependencePhase 2MAW Phase 3NCT02431611
Biomarker Feedback to Motivate Cessation in Pregnancy
A Phase 2 study testing Biomarker feedback (phone based smoking cessation counseling) in people with Nicotine Dependence and Pregnancy, run by Mayo Clinic at 1 site in United States.
Trial summary
Phase 3 Pilot Clinical Trial. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence, Pregnancy
- What is being tested?
- Biomarker feedback (phone based smoking cessation counseling)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Dec 2017
- Phase
- Phase 2
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Alaska Native
- 18 years or older
- provide written informed consent
- be currently pregnant and at <24 weeks gestation
- reside in Anchorage and plan to deliver at the ANMC
- current tobacco user defined as any use of Iqmik, commercial ST, and/or cigarettes during the past 7 days.
Who cannot join
- use of using nicotine replacement therapy or medications for tobacco cessation or participation in a behavioral cessation program within the past 30 days
- another woman from the same household has enrolled.
Trial locations and contacts
1 site in 1 country.
United States1 site
Alaska Native Tribal Health Consortium
Anchorage, Alaska, 99577
About this study
Official title: Biomarker Feedback to Motivate Tobacco Cessation in Pregnant Alaska Native Women (MAW) - Phase 3 Pilot Clinical Trial
Phase 3 Pilot Clinical Trial.
Read the detailed description
Developing effective tobacco cessation interventions during pregnancy for American Indian and Alaska Native people is a national priority and will contribute to the U.S. public health objective of reducing tobacco-related cancer health disparities. The proposed project builds on the investigators' successful partnership with the Alaska Native community and previous work with Alaska Native pregnant women. The investigators propose to develop and test a novel biomarker feedback intervention relating cotinine levels in the urine of pregnant women with the woman and infant's likely exposure to the tobacco specific nitrosamine and carcinogen 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone) (NNK). This 5-year project will be conducted in three phases. In Phase 1 the investigators will utilize a non-randomized, clinical observational trial to examine biomarkers of nicotine and carcinogen exposure (urine cotinine and total NNAL [a metabolite of NNK], respectively) among 150 maternal-infant pairs with assessments conducted during pregnancy and at delivery. In Phase 2, the investigators will obtain qualitative feedback on the findings from Phase 1 through individual interviews conducted with 32 women who use tobacco to develop the biomarker feedback intervention messages. Phase 3 will consist of a formative evaluation of the biomarker feedback intervention with 60 pregnant women using a two-group randomized design to assess the intervention's feasibility and acceptability, and the biochemically confirmed abstinence rate at the end of pregnancy. All phases of the project will be guided by a Community Advisory Committee. Each phase is an important step to advance the investigators' understanding of the potential for biomarker feedback as a strategy to help Alaska Native pregnant women quit tobacco use. The potential reach of the intervention is significant from a public health perspective as over 600 tobacco users deliver each year at the Alaska Native Medical Center in Anchorage where the proposed project will take place. Developing effective interventions for tobacco cessation during pregnancy is important to reduce adverse health consequences for the mother and neonate and future risk of tobacco-caused cancers.
This is the third and final phase of the project.
- Conditions
- Nicotine Dependence, Pregnancy
- Being tested
- Biomarker feedback (phone based smoking cessation counseling), Control condition (phone based smoking cessation counseling)
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomarker feedback (phone based smoking cessation counseling)Behavioural
Feedback on maternal cotinine and likely infant NNAL Phone based behavioral smoking cessation counseling
Control condition (phone based smoking cessation counseling)Behavioural
phone-based behavioral smoking cessation counseling
| Study group | Role | What they receive |
|---|---|---|
| Control condition | Active comparator | Control behavioral phone-based smoking cessation intervention Receives: Behavioral: Control condition (phone based smoking cessation counseling) |
| Biomarker Feedback Intervention | Experimental | Biomarker feedback plus behavioral phone-based smoking cessation intervention Receives: Behavioral: Biomarker feedback (phone based smoking cessation counseling) |
What is being measured
The primary outcome is the main question the study is designed to answer.
smoking abstinence in late pregnancy (self-reported abstinence verified with cotinine)
self-reported abstinence verified with cotinine
Measured: at week 36 gestation or greater up to the time of delivery
Secondary outcomes (1)
Self-efficacy (Self-reported confidence scale)
Self-reported confidence scale
Measured: at week 36 gestation or greater up to the time of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Alaska Native Tribal Health Consortium, University of California, San Francisco, University of Minnesota
- Responsible party
- Principal investigator, Christi Patten, Mayo Clinic
- Investigators
- Christi A Patten, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02431611
- Sponsor's protocol ID
- 11-001144-02
- Acronym
- MAW Phase 3
- Status last verified
- Dec 2017
- First submitted
- 14 Apr 2015
- Last updated
- 19 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker Feedback to Motivate Tobacco Cessation in Pregnant Alaska Native Women (MAW) - Phase 3 Pilot Clinical Trial
- ClinicalTrials.gov ID
- NCT02431611
- Acronym / sponsor ID
- MAW Phase 3 / 11-001144-02
- Conditions
- Nicotine Dependence, Pregnancy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Alaska Native Tribal Health Consortium, University of California, San Francisco, University of Minnesota
- Study start
- Mar 2015
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 1 May 2015 (estimated)
- 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.
Phase 3 Pilot Clinical Trial.
Detailed description
Developing effective tobacco cessation interventions during pregnancy for American Indian and Alaska Native people is a national priority and will contribute to the U.S. public health objective of reducing tobacco-related cancer health disparities. The proposed project builds on the investigators' successful partnership with the Alaska Native community and previous work with Alaska Native pregnant women. The investigators propose to develop and test a novel biomarker feedback intervention relating cotinine levels in the urine of pregnant women with the woman and infant's likely exposure to the tobacco specific nitrosamine and carcinogen 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone) (NNK). This 5-year project will be conducted in three phases. In Phase 1 the investigators will utilize a non-randomized, clinical observational trial to examine biomarkers of nicotine and carcinogen exposure (urine cotinine and total NNAL [a metabolite of NNK], respectively) among 150 maternal-infant pairs with assessments conducted during pregnancy and at delivery. In Phase 2, the investigators will obtain qualitative feedback on the findings from Phase 1 through individual interviews conducted with 32 women who use tobacco to develop the biomarker feedback intervention messages. Phase 3 will consist of a formative evaluation of the biomarker feedback intervention with 60 pregnant women using a two-group randomized design to assess the intervention's feasibility and acceptability, and the biochemically confirmed abstinence rate at the end of pregnancy. All phases of the project will be guided by a Community Advisory Committee. Each phase is an important step to advance the investigators' understanding of the potential for biomarker feedback as a strategy to help Alaska Native pregnant women quit tobacco use. The potential reach of the intervention is significant from a public health perspective as over 600 tobacco users deliver each year at the Alaska Native Medical Center in Anchorage where the proposed project will take place. Developing effective interventions for tobacco cessation during pregnancy is important to reduce adverse health consequences for the mother and neonate and future risk of tobacco-caused cancers.
This is the third and final phase of the project.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control condition | Active comparator | Behavioral: Control condition (phone based smoking cessation counseling)Control behavioral phone-based smoking cessation intervention |
| Biomarker Feedback Intervention | Experimental | Behavioral: Biomarker feedback (phone based smoking cessation counseling)Biomarker feedback plus behavioral phone-based smoking cessation intervention |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Alaska Native
- 18 years or older
- provide written informed consent
- be currently pregnant and at <24 weeks gestation
- reside in Anchorage and plan to deliver at the ANMC
Key exclusion criteria (2 listed)
- use of using nicotine replacement therapy or medications for tobacco cessation or participation in a behavioral cessation program within the past 30 days
- another woman from the same household has enrolled.
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 |
|---|---|---|
| Biomarker feedback (phone based smoking cessation counseling)Feedback on maternal cotinine and likely infant NNAL Phone based behavioral smoking cessation counseling | Behavioural | Biomarker Feedback Intervention |
| Control condition (phone based smoking cessation counseling)phone-based behavioral smoking cessation counseling | Behavioural | Control condition |
Primary outcome
smoking abstinence in late pregnancy (self-reported abstinence verified with cotinine)
Time frame: at week 36 gestation or greater up to the time of delivery
self-reported abstinence verified with cotinine
1 secondary outcome
Self-efficacy (Self-reported confidence scale)
Time frame: at week 36 gestation or greater up to the time of delivery
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 Dec 2017.
- Individual participant dataSharing planned: No
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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.
Christi A Patten, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Biomarker feedback (phone based smoking cessation counseling) in people with Nicotine Dependence and Pregnancy, run by Mayo Clinic 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 6 inclusion and 2 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 Dec 2017. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
smoking abstinence in late pregnancy (self-reported abstinence verified with cotinine) (time frame: at week 36 gestation or greater up to the time of delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Dec 2017.