Nicotine Dependence, Smoking Cessation
Conditions
Keywords
Smoking Cessation, Pregnancy, Nicotrol Inhaler, Placebo Inhaler, Nicotine Inhaler
Brief 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).
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
Interventions
DRUGNicotrol Inhaler
Nicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper
DRUGPlacebo Inhaler
Placebo inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
UConn Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
16 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Self Report an Average of Zero Cigarettes Smoked Per Day in Preceding 7 Days | 32-34 weeks gestation (Visit 6) | Number of participants who self report an average of zero cigarettes smoked per day in preceding 7 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Exhaled Carbon Monoxide | 32-34 weeks gestation | As measured by parts per million (ppm) on CO breathalyzer |
| Birth Weight | At delivery | Birth weight in grams |
| Gestational Age | At delivery | Measure of age of pregnancy at delivery |
Countries
United States
Participant flow
Recruitment details
Participants were recruited beginning August 20, 2012. Enrollment sites included Hartford Hospital (Hartford, CT) and Baystate Medical Center (Springfield, MA).
Pre-assignment details
154 participants gave written consent for study participation and 137 were randomized. Therefore, 17 participants were excluded for the following reasons: no show after screen (10), high PHQ9 (2), moved out of area (2), current drug use (1), advanced gestational age (1), and stress too high to continue (1).
Participants by arm
| Arm | Count |
|---|---|
| Placebo Inhaler Placebo inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper | 67 |
| Nicotrol Inhaler Nicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper. | 70 |
| Total | 137 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Delivery at another hospital | 0 | 2 |
| Overall Study | No permission to collect birth outcomes | 0 | 1 |
| Overall Study | Spontaneous abortion | 0 | 1 |
Baseline characteristics
| Characteristic | Nicotrol Inhaler | Total | Placebo Inhaler |
|---|---|---|---|
| Age, Continuous | 26.97 years STANDARD_DEVIATION 5.45 | 27.59 years STANDARD_DEVIATION 5.9 | 28.24 years STANDARD_DEVIATION 6.3 |
| Highest level of education completed College or post college completed | 16 participants | 32 participants | 16 participants |
| Highest level of education completed Grade School Completed | 18 participants | 38 participants | 20 participants |
| Highest level of education completed High School Completed | 36 participants | 67 participants | 31 participants |
| Number of cigarettes per day last two weeks | 3.48 cigarettes per day STANDARD_DEVIATION 3.29 | 4.14 cigarettes per day STANDARD_DEVIATION 3.99 | 5.03 cigarettes per day STANDARD_DEVIATION 4.69 |
| Number of Cigs/day | 8.66 cigarettes per day STANDARD_DEVIATION 4.71 | 8.36 cigarettes per day STANDARD_DEVIATION 4.64 | 8.04 cigarettes per day STANDARD_DEVIATION 4.59 |
| Race/Ethnicity, Customized Hispanic or Latino | 28 Participants | 61 Participants | 33 Participants |
| Race/Ethnicity, Customized Non-Hispanic, Black | 14 Participants | 22 Participants | 8 Participants |
| Race/Ethnicity, Customized Non-Hispanic, White | 26 Participants | 51 Participants | 25 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Unknown | 1 Participants | 2 Participants | 1 Participants |
| Sex: Female, Male Female | 70 Participants | 137 Participants | 67 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 67 | 0 / 70 |
| other Total, other adverse events | 0 / 67 | 12 / 70 |
| serious Total, serious adverse events | 40 / 67 | 28 / 70 |
Outcome results
Primary
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
Time frame: 32-34 weeks gestation (Visit 6)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo Inhaler | Number of Participants Who Self Report an Average of Zero Cigarettes Smoked Per Day in Preceding 7 Days | 12 Participants |
| Nicotrol Inhaler | Number of Participants Who Self Report an Average of Zero Cigarettes Smoked Per Day in Preceding 7 Days | 7 Participants |
Secondary
Birth Weight
Birth weight in grams
Time frame: At delivery
Population: Could not obtain birth outcomes on 4 individuals in nicotine group for various reasons.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Inhaler | Birth Weight | 3036.78 Grams | Standard Deviation 583.8 |
| Nicotrol Inhaler | Birth Weight | 3141.12 Grams | Standard Deviation 561.94 |
Secondary
Exhaled Carbon Monoxide
As measured by parts per million (ppm) on CO breathalyzer
Time frame: 32-34 weeks gestation
Population: Overall number of participants includes only those that attended the 32-34 gestation week visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Inhaler | Exhaled Carbon Monoxide | 5.50 parts per million | Standard Deviation 5.42 |
| Nicotrol Inhaler | Exhaled Carbon Monoxide | 6.7 parts per million | Standard Deviation 7.4 |
Secondary
Gestational Age
Measure of age of pregnancy at delivery
Time frame: At delivery
Population: Could not obtain birth outcomes on 4 individuals in nicotine group for various reasons.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo Inhaler | Gestational Age | 38.61 weeks | Standard Deviation 2.53 |
| Nicotrol Inhaler | Gestational Age | 39.11 weeks | Standard Deviation 2.42 |