Tobacco Use DisorderNCT00888979
Pilot Study of Nicotine Replacement for Smoking Cessation During Pregnancy
A study testing Nicotrol Inhaler in people with Tobacco Use Disorder, run by Hartford Hospital at 1 site in United States.
Trial summary
We plan to examine the feasibility, acceptability, preliminary quit rates, overall nicotine exposure and adverse effects of the nicotine inhaler for smoking cessation in pregnancy. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- Nicotrol Inhaler
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Apr 2014
- Phase
- Interventional
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 13-26 weeks pregnant
- Smoking at least 5 cigarettes per day the preceding 7 days
- Motivated to quit smoking (at least 7 on a 10 pt. scale)
- Able to speak English
- Intend to carry pregnancy to term
- Stable residence
Who cannot join
- Current drug or alcohol abuse or dependence (other than methadone maintenance
- Twins or multiple gestation
- Unstable psychiatric disorder
- Unstable medical problems
- Known congenital abnormality
- High risk pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
We plan to examine the feasibility, acceptability, preliminary quit rates, overall nicotine exposure and adverse effects of the nicotine inhaler for smoking cessation in pregnancy.
Read the detailed description
Subjects in this pilot study are healthy pregnant women who wish to quit smoking. They will set a quit date and use the nicotine inhaler for 4 weeks. They will receive behavioral counseling in addition to the inhaler for 4 weeks.
- Conditions
- Tobacco Use Disorder
- Being tested
- Nicotrol Inhaler
- Keywords
- Smoking Cessation during Pregnancy, Nicotrol Inhaler
- 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.
Nicotrol InhalerDrug
10 mg of nicotine per one inhaler cartridge. Inhaler use will substitute the usual smoking pattern
| Study group | Role | What they receive |
|---|---|---|
| Nicotrol with Behavioral Counseling | Experimental | Nicotrol Inhaler: 10 mg of nicotine per one inhaler cartridge. Inhaler use will substitute the usual smoking pattern Receives: Drug: Nicotrol Inhaler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Days of Inhaler Use
Measured: Baseline to 4 weeks
Secondary outcomes (2)
Cartridge Use
Measured: Baseline to 4 weeks
Change in Number of Cigarettes Used Per Day From Baseline to 4 Weeks.
Measured: Baseline to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionMay 2011
- Study completionApr 2014
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.
- Other trials for Tobacco Use DisorderStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hartford Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- UConn Health
- Responsible party
- Sponsor
- Investigators
- Cheryl Oncken, MD MPH, Principal investigator, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00888979
- Sponsor's protocol ID
- ONCK002885HU
- Other IDs
- H09-183-2
- Status last verified
- Nov 2016
- First submitted
- 24 Apr 2009
- Last updated
- 9 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Nicotine Replacement for Smoking Cessation During Pregnancy
- ClinicalTrials.gov ID
- NCT00888979
- Acronym / sponsor ID
- ONCK002885HU
- Conditions
- Tobacco Use Disorder
- Keywords
- Smoking Cessation during Pregnancy, Nicotrol Inhaler
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hartford HospitalUniversity, hospital or other
- Collaborators
- UConn Health
- Study start
- Apr 2009
- Primary completion
- May 2011 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 28 Apr 2009 (estimated)
- Results
- Posted 9 Jan 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We plan to examine the feasibility, acceptability, preliminary quit rates, overall nicotine exposure and adverse effects of the nicotine inhaler for smoking cessation in pregnancy.
Detailed description
Subjects in this pilot study are healthy pregnant women who wish to quit smoking. They will set a quit date and use the nicotine inhaler for 4 weeks. They will receive behavioral counseling in addition to the inhaler for 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nicotrol with Behavioral Counseling | Experimental | Drug: Nicotrol InhalerNicotrol Inhaler: 10 mg of nicotine per one inhaler cartridge. Inhaler use will substitute the usual smoking pattern |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 13-26 weeks pregnant
- Smoking at least 5 cigarettes per day the preceding 7 days
- Motivated to quit smoking (at least 7 on a 10 pt. scale)
- Able to speak English
- Intend to carry pregnancy to term
Key exclusion criteria (6 listed)
- Current drug or alcohol abuse or dependence (other than methadone maintenance
- Twins or multiple gestation
- Unstable psychiatric disorder
- Unstable medical problems
- 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 Inhaler10 mg of nicotine per one inhaler cartridge. Inhaler use will substitute the usual smoking pattern | Drug | Nicotrol with Behavioral Counseling |
Primary outcome
Number of Days of Inhaler Use
Time frame: Baseline to 4 weeks
2 secondary outcomes
Cartridge Use
Time frame: Baseline to 4 weeks
Change in Number of Cigarettes Used Per Day From Baseline to 4 Weeks.
Time frame: Baseline to 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Cheryl Oncken, MD MPH principal investigator
UConn Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicotrol Inhaler in people with Tobacco Use Disorder, run by Hartford Hospital 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 6 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 9 Jan 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jan 2017). 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 Days of Inhaler Use (time frame: Baseline to 4 weeks). 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 9 Jan 2017.