Nicotine Replacement Treatment for Pregnant Smokers - 1
Public ClinicalTrials.gov record NCT00115687. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Nicotine Replacement Treatment for Pregnant Smokers
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Smoking during pregnancy is an important modifiable cause of poor pregnancy outcomes. Even with augmented behavioral interventions, smoking cessation rates in pregnancy trials rarely exceed 20%. These low quit rates may be due to inadequate treatment of the physical dependence on nicotine. Indeed, medications, which may help to reduce nicotine withdrawal symptoms, are a first-line treatment for smoking treatment in non-pregnant smokers. However, little information is available on the safety or efficacy of medications to treat pregnant smokers. The purpose of this trial is to evaluate the safety and effectiveness of 2 mg nicotine gum in promoting smoking cessation during pregnancy. The design is a randomized, placebo controlled trial where subjects are randomized to nicotine gum (6 weeks ad libitum use followed by a 6 week taper) or a matching placebo. Women who are doing well at the end of the trial will also be offered gum post-partum for relapse prevention.
Study identification
- NCT ID
- NCT00115687
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 250 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 16 Years to 50 Years
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 2002 (Type not available)
- Primary completion
- Apr 2007 (Actual)
- Completion
- Apr 2007 (Actual)
- Last update posted
- Jan 12, 2017
2002 – 2007
United States locations
- U.S. sites
- 4
- U.S. states
- 2
- U.S. cities
- 4
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Connecticut Health Center | Farmington | Connecticut | 06030 | — |
| Hartford Hospital | Hartford | Connecticut | 06106 | — |
| The Hospital of Central Connecticut | New Britain | Connecticut | 06050 | — |
| Baystate Medical Center | Springfield | Massachusetts | 01199 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00115687, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 12, 2017 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00115687 live on ClinicalTrials.gov.