Smoking Cessation
Conditions
Keywords
Smoking cessation during pregnancy, bupropion
Brief summary
This study is designed to gather preliminary effectiveness and safety data on the use of bupropion for smoking cessation in pregnant women attending a community prenatal clinic. This study will provide critical preliminary data in preparation for a larger, Phase III clinical trial.
Detailed description
A randomized, double-blind, parallel group design will be used to allow a rigorous preliminary assessment of the feasibility, effectiveness, and safety of bupropion SR (sustained release; packaged as Zyban by GlaxoSmithKline) in promoting smoking cessation among women in their second and third trimester of pregnancy. Fifty pregnant smokers will be randomized to receive an 8-week course of either bupropion SR or matching placebo tablets. Both groups will receive evidence-based smoking cessation counseling. The primary smoking outcome will be 7-day point prevalence abstinence with cotinine validation at the end of the treatment. Secondary outcomes include enrollment, retention, and compliance rates; continuous abstinence from end of treatment through the 2 week followup; continuous abstinence from birth to 2nd week postpartum followup; self-reported reduction in number of cigarettes smoked per day; and maternal side effects and perinatal/neonatal outcomes. Preliminary smoking cessation and safety outcomes will be assessed for the generation of evidence-based hypotheses regarding clinical benefit of bupropion for pregnant smokers in preparation fo a larger trial.
Interventions
DRUGBupropion SR
* 150mg, taken orally, taken daily for the 1st 3 days * 300mg, taken orally, taken daily for the rest of the 8 weeks of drug treatment
OTHERPlacebo
-Avicel PH 302, Emcocel 50M, Cab-O-Sil M5P, Magnesium Stearate (appearance, taste, and dosing instructions were identical to the bupropion group), i.e., 1 pill orally, taken daily for the 1st 3 days; 2 pills, taken orally, taken daily for the rest of the 8 weeks of drug treatment
Sponsors
M.D. Anderson Cancer Center
Gilstrap, Larry C, M.D.
The Center for Clinical and Translational Sciences (CCTS) Clinical Research Unit at The University of Texas Health Science Center at Houston
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pregnant women ≥ 18 years of age * Gestational age between 14 and 26 weeks confirmed by ultrasound * Currently smoking ≥ 5 cigarettes per day
Exclusion criteria
* Abnormal liver function tests * History of or current seizure disorder or closed head injury with loss of consciousness * Known hypersensitivity to bupropion * Any psychiatric disorder requiring psychotropic medication * Current anorexia or bulimia * Use of monoamine oxidase (MAO) inhibitors or discontinuation within the past 2 weeks * Major Depressive Disorder or current suicidal risk * Use of any illicit substances since receiving knowledge of pregnancy * Regular use of alcohol (\>1 drink/week on average) * Unstable medical problems, such as liver or renal disease, uncontrollable hypertension, and lupus * Twins or other multiple gestation * Fetal abnormality on the 14 week ultrasound * Plans to deliver at a hospital other than Memorial Hermann * Inability to communicate with research staff or make study visits due to lack of phone or transportation access * Participation in another clinical study which may affect study outcomes * Current use of any Nicotine Replacement Therapy (NRT), bupropion, or varenicline (Chantix)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 7-day Point Prevalence Smoking Abstinence With Cotinine Validation at the End of Treatment | 1 week post treatment |
Secondary
| Measure | Time frame |
|---|---|
| Continuous Abstinence From End of Treatment Through the 2 Week Followup | at two week followup visit |
| Continuous Abstinence From Birth to 2nd Week Postpartum Followup | at 2nd week postpartum followup visit |
| Enrollment, Retention and Compliance Rates | 1 year (estimated) |
| Maternal Side Effects | during treatment, end of treatment and at 2 week postpartum visit |
| Perinatal/Neonatal Outcomes | at neonatal discharge from hospital following delivery |
| Self-reported Reduction in Number of Cigarettes Smoked Per Day | at 1 week post treatment and at 2 week postpartum visit |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Bupropion SR (Sustained Release) Group receiving bupropion SR medication
Bupropion SR: - 150mg, taken orally, taken daily for the 1st 3 days
\- 300mg, taken orally, taken daily for the rest of the 8 weeks of drug treatment | 5 |
| Placebo Group receiving placebo
-Avicel PH 302, Emcocel 50M, Cab-O-Sil M5P, Magnesium Stearate (appearance, taste, and dosing instructions were identical to the bupropion group), i.e., 1 pill orally, taken daily for the 1st 3 days; 2 pills, taken orally, taken daily for the rest of the 8 weeks of drug treatment | 6 |
| Total | 11 |
Baseline characteristics
| Characteristic | Placebo | Total | Bupropion SR (Sustained Release) |
|---|---|---|---|
| Age, Continuous | 26.7 years STANDARD_DEVIATION 5.9 | 26.9 years STANDARD_DEVIATION 5.5 | 27.2 years STANDARD_DEVIATION 5.6 |
| Age started smoking | 17.3 years STANDARD_DEVIATION 9 | 17.5 years STANDARD_DEVIATION 4.3 | 17.8 years STANDARD_DEVIATION 3 |
| Carbon monoxide reading | 15.2 parts per million STANDARD_DEVIATION 17.5 | 12.0 parts per million STANDARD_DEVIATION 12.4 | 8.8 parts per million STANDARD_DEVIATION 3.7 |
| # cigs smoked in past 30 days | 10.7 cigarettes STANDARD_DEVIATION 5.4 | 10.7 cigarettes STANDARD_DEVIATION 8 | 10.8 cigarettes STANDARD_DEVIATION 11.1 |
| Region of Enrollment United States | 6 participants | 11 participants | 5 participants |
| Sex: Female, Male Female | 6 Participants | 11 Participants | 5 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 | — / — | — / — |
| other Total, other adverse events | 2 / 5 | 3 / 6 |
| serious Total, serious adverse events | 2 / 5 | 0 / 6 |
Outcome results
Primary
7-day Point Prevalence Smoking Abstinence With Cotinine Validation at the End of Treatment
Time frame: 1 week post treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Bupropion SR (Sustained Release) | 7-day Point Prevalence Smoking Abstinence With Cotinine Validation at the End of Treatment | 0 participants |
| Placebo | 7-day Point Prevalence Smoking Abstinence With Cotinine Validation at the End of Treatment | 2 participants |
Secondary
Continuous Abstinence From Birth to 2nd Week Postpartum Followup
Time frame: at 2nd week postpartum followup visit
Secondary
Continuous Abstinence From End of Treatment Through the 2 Week Followup
Time frame: at two week followup visit
Secondary
Enrollment, Retention and Compliance Rates
Time frame: 1 year (estimated)
Secondary
Maternal Side Effects
Time frame: during treatment, end of treatment and at 2 week postpartum visit
Secondary
Perinatal/Neonatal Outcomes
Time frame: at neonatal discharge from hospital following delivery
Secondary
Self-reported Reduction in Number of Cigarettes Smoked Per Day
Time frame: at 1 week post treatment and at 2 week postpartum visit