Tobacco Use Disorder
Conditions
Keywords
Smoking Cessation during Pregnancy, Nicotrol Inhaler
Brief 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.
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.
Interventions
DRUGNicotrol Inhaler
10 mg of nicotine per one inhaler cartridge. Inhaler use will substitute the usual smoking pattern
Sponsors
UConn Health
Hartford Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Days of Inhaler Use | Baseline to 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Cartridge Use | Baseline to 4 weeks |
| Change in Number of Cigarettes Used Per Day From Baseline to 4 Weeks. | Baseline to 4 weeks |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Nicotrol Inhaler With Behavioral Counseling Nicotrol Inhaler: 10 mg of nicotine per one inhaler cartridge. Inhaler use will substitute the usual smoking pattern | 8 |
| Total | 8 |
Baseline characteristics
| Characteristic | Nicotrol Inhaler With Behavioral Counseling |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Age, Continuous | 26 years |
| Gender Female | 8 Participants |
| Gender Male | 0 Participants |
| Region of Enrollment United States | 8 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 4 / 8 |
| serious Total, serious adverse events | 1 / 8 |
Outcome results
Primary
Number of Days of Inhaler Use
Time frame: Baseline to 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nicotrol Inhaler With Behavioral Counseling | Number of Days of Inhaler Use | 26.4 days | Standard Deviation 3 |
Secondary
Cartridge Use
Time frame: Baseline to 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nicotrol Inhaler With Behavioral Counseling | Cartridge Use | 2 cartridges per day | Standard Deviation 1.5 |
Secondary
Change in Number of Cigarettes Used Per Day From Baseline to 4 Weeks.
Time frame: Baseline to 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nicotrol Inhaler With Behavioral Counseling | Change in Number of Cigarettes Used Per Day From Baseline to 4 Weeks. | -5.7 reduction in number of CPD | Standard Deviation 2.3 |