Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00115687
Status:
TERMINATED
Last Update Posted:
2017-01-12
First Post:
2005-06-23
Brief Title:
Nicotine Replacement Treatment for Pregnant Smokers - 1
Sponsor:
National Institute on Drug Abuse NIDA
Organization:
National Institute on Drug Abuse NIDA
Study Overview
Official Title:
Nicotine Replacement Treatment for Pregnant Smokers
Status:
TERMINATED
Status Verified Date:
2010-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Efficacy rates did not show large enough differences between treatments
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
This proposal will examine the utility of one first-line medication nicotine gum as an aid to smoking cessation during pregnancy
The specific aims are
1 To compare smoking cessation rates and smoking reduction among pregnant smokers who are randomized to receive nicotine gum 2 mg dose or a matching placebo
2 To compare nicotine gum versus placebo on surrogate measures of maternal and fetal safety ie overall nicotine and tobacco exposure at 6 weeks after the quit date and at 32-34 weeks gestation and birth weight at the time of delivery
3 To examine which subjects benefit the most from the use of nicotine gum for smoking cessation during pregnancy
Subjects will be recruited from prenatal clinics that serve primarily a low-income minority population Two hundred sixty-eight pregnant smokers will be randomly assigned to receive smoking cessation behavioral counseling and either a 6-week course of mint flavored placebo or nicotine gum followed by 6 weeks of decreasing doses Maternal blood for genotyping will be obtained at study entry Primary outcome measures will be 7-day point prevalence of cigarette abstinence number of cigarettes smoked per day urinary cotinine concentrations and measures of tobacco exposure ie carbon monoxide in exhaled air and urine anabasine and anatabine at 6 weeks after the quit date and at 32-34 weeks gestation and infant birth weight We hypothesize that
1 Pregnant smokers who are randomized to nicotine gum will have double the quit rates and will reduce their smoking to a greater degree than subjects randomized to placebo
2 Nicotine gum compared to placebo will reduce maternal levels of tobacco-exposure markers and increase birth weights in the offspring
3 The odds of cigarette abstinence will be increased primarily in subjects who smoke at least 15 cigarettes per day
The specific aims are
1 To compare smoking cessation rates and smoking reduction among pregnant smokers who are randomized to receive nicotine gum 2 mg dose or a matching placebo
2 To compare nicotine gum versus placebo on surrogate measures of maternal and fetal safety ie overall nicotine and tobacco exposure at 6 weeks after the quit date and at 32-34 weeks gestation and birth weight at the time of delivery
3 To examine which subjects benefit the most from the use of nicotine gum for smoking cessation during pregnancy
Subjects will be recruited from prenatal clinics that serve primarily a low-income minority population Two hundred sixty-eight pregnant smokers will be randomly assigned to receive smoking cessation behavioral counseling and either a 6-week course of mint flavored placebo or nicotine gum followed by 6 weeks of decreasing doses Maternal blood for genotyping will be obtained at study entry Primary outcome measures will be 7-day point prevalence of cigarette abstinence number of cigarettes smoked per day urinary cotinine concentrations and measures of tobacco exposure ie carbon monoxide in exhaled air and urine anabasine and anatabine at 6 weeks after the quit date and at 32-34 weeks gestation and infant birth weight We hypothesize that
1 Pregnant smokers who are randomized to nicotine gum will have double the quit rates and will reduce their smoking to a greater degree than subjects randomized to placebo
2 Nicotine gum compared to placebo will reduce maternal levels of tobacco-exposure markers and increase birth weights in the offspring
3 The odds of cigarette abstinence will be increased primarily in subjects who smoke at least 15 cigarettes per day
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DPMCDA | None | None | None |
| R01-15167-1 | None | None | None |