Nicotine DependencePhase 4NCT01656733
Nicotine Replacement for Smoking Cessation During Pregnancy
A Phase 4 study testing Nicotrol Inhaler in people with Nicotine Dependence and Smoking Cessation, run by UConn Health at 2 sites in United States.
Trial summary
This is a clinical trial to determine if the nicotine inhaler in combination with counseling will help pregnant women quit smoking, and whether it is safe when compared to placebo (an inactive inhaler). Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence, Smoking Cessation
- What is being tested?
- Nicotrol Inhaler
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 154 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2012to 25 Oct 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- smoking at least 5 cigarettes per day for the preceding 7 days
- previous attempt to quit smoking during pregnancy by self report
- 13-26 weeks gestation
- at least 16 years of age
- able to speak English or Spanish
- intent to carry pregnancy to term
- stable residence
Who cannot join
- current drug or alcohol abuse or dependence (other than methadone maintenance)
- twins or other multiple gestation
- unstable psychiatric disorder
- unstable medical problems (e.g., pre-eclampsia, threatened abortion, hyperemesis gravidarum)
- known congenital abnormality
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Women's Ambulatory Health Services at Hartford Hospital
Hartford, Connecticut, 06106
Wesson Women's Clinic at Baystate Medical Center
Springfield, Massachusetts, 01199
About this study
This is a clinical trial to determine if the nicotine inhaler in combination with counseling will help pregnant women quit smoking, and whether it is safe when compared to placebo (an inactive inhaler).
Read the detailed description
This project will examine the safety and efficacy of the nicotine inhaler as an aid to smoking cessation during pregnancy. The specific aims are: (1) To examine the efficacy of the nicotine inhaler compared to a matching placebo for smoking cessation during pregnancy; (2) To compare the nicotine inhaler with placebo on overall nicotine exposure (i.e., serum cotinine concentrations), and on birth outcomes (i.e., birth weight and gestational age); (3) To identify factors that determine which women benefit most from the use of the nicotine inhaler for smoking cessation during pregnancy; (4) To explore mechanisms by which the nicotine inhaler increases birth weight and gestational age.
Subjects will be recruited from two prenatal clinics that serve primarily a low-income, minority population.
Pregnant smokers (n=270) who smoke at least 5 cigarettes/ day will receive nurse-delivered behavioral counseling and be randomized to receive a 6-week course of treatment with either a nicotine inhaler or placebo, followed by a 6-week taper. Birth outcomes will be obtained on all participants
- Conditions
- Nicotine Dependence, Smoking Cessation
- Being tested
- Nicotrol Inhaler, Placebo Inhaler
- Keywords
- Smoking Cessation, Pregnancy, Nicotrol Inhaler, Placebo Inhaler, Nicotine Inhaler
- Medical subject headings
- Tobacco Use Disorder, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotrol InhalerDrug
Also called Nicotine Inhaler
Nicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper
Placebo InhalerDrug
Placebo inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper
| Study group | Role | What they receive |
|---|---|---|
| Nicotrol Inhaler | Experimental | Nicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper. Receives: Drug: Nicotrol Inhaler |
| Placebo Inhaler | Placebo comparator | Placebo inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper Receives: Drug: Placebo Inhaler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Self Report an Average of Zero Cigarettes Smoked Per Day in Preceding 7 Days
Number of participants who self report an average of zero cigarettes smoked per day in preceding 7 days
Measured: 32-34 weeks gestation (Visit 6)
Secondary outcomes (3)
Exhaled Carbon Monoxide
As measured by parts per million (ppm) on CO breathalyzer
Measured: 32-34 weeks gestation
Birth Weight
Birth weight in grams
Measured: At delivery
Gestational Age
Measure of age of pregnancy at delivery
Measured: At delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2012 (estimated)
- Study startAug 2012
- Primary completion30 Sep 2017
- Study completion25 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Cheryl Oncken, UConn Health
- Investigators
- Cheryl Oncken, M.D., M.P.H., Principal investigator, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01656733
- Sponsor's protocol ID
- 11-057-6
- Other IDs
- 1R01HD069314-01A1
- Status last verified
- Sep 2019
- First submitted
- 1 Aug 2012
- Last updated
- 30 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Oncken C, Dornelas EA, Kuo CL, Sankey HZ, Kranzler HR, Mead EL, Thurlow MSD. Randomized Trial of Nicotine Inhaler for Pregnant Smokers. Am J Obstet Gynecol MFM. 2019 Mar;1(1):10-18. doi: 10.1016/j.ajogmf.2019.03.006. Epub 2019 Mar 27.
PubMed 31380506
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nicotine Replacement for Smoking Cessation During Pregnancy
- ClinicalTrials.gov ID
- NCT01656733
- Acronym / sponsor ID
- 11-057-6
- Conditions
- Nicotine Dependence, Smoking Cessation
- Keywords
- Smoking Cessation, Pregnancy, Nicotrol Inhaler, Placebo Inhaler, Nicotine Inhaler
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Aug 2012
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 25 Oct 2017 (actual)
- First posted
- 3 Aug 2012 (estimated)
- Results
- Posted 30 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a clinical trial to determine if the nicotine inhaler in combination with counseling will help pregnant women quit smoking, and whether it is safe when compared to placebo (an inactive inhaler).
Detailed description
This project will examine the safety and efficacy of the nicotine inhaler as an aid to smoking cessation during pregnancy. The specific aims are: (1) To examine the efficacy of the nicotine inhaler compared to a matching placebo for smoking cessation during pregnancy; (2) To compare the nicotine inhaler with placebo on overall nicotine exposure (i.e., serum cotinine concentrations), and on birth outcomes (i.e., birth weight and gestational age); (3) To identify factors that determine which women benefit most from the use of the nicotine inhaler for smoking cessation during pregnancy; (4) To explore mechanisms by which the nicotine inhaler increases birth weight and gestational age.
Subjects will be recruited from two prenatal clinics that serve primarily a low-income, minority population.
Pregnant smokers (n=270) who smoke at least 5 cigarettes/ day will receive nurse-delivered behavioral counseling and be randomized to receive a 6-week course of treatment with either a nicotine inhaler or placebo, followed by a 6-week taper. Birth outcomes will be obtained on all participants
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nicotrol Inhaler | Experimental | Drug: Nicotrol InhalerNicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper. |
| Placebo Inhaler | Placebo comparator | Drug: Placebo InhalerPlacebo inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- smoking at least 5 cigarettes per day for the preceding 7 days
- previous attempt to quit smoking during pregnancy by self report
- 13-26 weeks gestation
- at least 16 years of age
- able to speak English or Spanish
Key exclusion criteria (5 listed)
- current drug or alcohol abuse or dependence (other than methadone maintenance)
- twins or other multiple gestation
- unstable psychiatric disorder
- unstable medical problems (e.g., pre-eclampsia, threatened abortion, hyperemesis gravidarum)
- known congenital abnormality
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 |
|---|---|---|
| Nicotrol InhalerAlso: Nicotine InhalerNicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper | Drug | Nicotrol Inhaler |
| Placebo InhalerPlacebo inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper | Drug | Placebo Inhaler |
Primary outcome
Number of Participants Who Self Report an Average of Zero Cigarettes Smoked Per Day in Preceding 7 Days
Time frame: 32-34 weeks gestation (Visit 6)
Number of participants who self report an average of zero cigarettes smoked per day in preceding 7 days
3 secondary outcomes
Exhaled Carbon Monoxide
Time frame: 32-34 weeks gestation
Birth Weight
Time frame: At delivery
Gestational Age
Time frame: At delivery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31380506Oncken C, Dornelas EA, Kuo CL, Sankey HZ, Kranzler HR, Mead EL, Thurlow MSD. Randomized Trial of Nicotine Inhaler for Pregnant Smokers. Am J Obstet Gynecol MFM. 2019 Mar;1(1):10-18. doi: 10.1016/j.ajogmf.2019.03.006. Epub 2019 Mar 27.
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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.
Cheryl Oncken, M.D., M.P.H. principal investigator
UConn Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nicotrol Inhaler in people with Nicotine Dependence and Smoking Cessation, run by UConn Health at 2 sites 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 7 inclusion and 5 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 30 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Who Self Report an Average of Zero Cigarettes Smoked Per Day in Preceding 7 Days (time frame: 32-34 weeks gestation (Visit 6)). 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 NCT01656733, 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 30 Sep 2019.