- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01875172
Bupropion for Smoking Cessation in Pregnancy
Smoking Cessation in Pregnancy: A Pilot Study Comparing Counseling With and Without Sustained-Release Bupropion
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Primary Objective:
To evaluate the efficacy of a pharmacologic agent (bupropion SR) to achieve higher rates of smoking cessation and greater reduction in smoking during pregnancy
Secondary Objective:
To evaluate the safety of using a pharmacologic agent (bupropion SR) for smoking cessation in pregnancy.
Hypotheses to be tested:
- Bupropion SR combined with smoking cessation counseling during pregnancy will increase smoking cessation, compared to smoking cessation counseling combined with placebo, or standard of care.
- Bupropion SR combined with smoking cessation counseling during pregnancy will produce greater reduction in smoking in patients unable to quit, as compared to smoking cessation counseling combined with placebo, or standard of care.
- Bupropion SR combined with smoking cessation counseling during pregnancy will improve perinatal outcomes (by decreasing preterm birth, preterm premature rupture of membranes, antenatal bleeding, low birth weight, intrauterine growth restriction and increasing maternal weight gain), as compared to smoking cessation counseling combined with placebo, or standard of care.
- Bupropion SR combined with smoking cessation counseling during pregnancy will increase the rate of smoking cessation without increasing the number of adverse events reported by women, as compared to smoking cessation counseling combined with placebo, or standard of care.
Few studies have offered pregnant women pharmacologic assistance with their tobacco addiction for the purpose of achieving smoking cessation in pregnancy. In view of the evidence from the non-pregnant population, pharmacologic assistance with either nicotine replacement therapy or bupropion is essential to significant cessation and reduction programs. This pilot study is designed to generate sufficient preliminary data to support future grant applications to state and/or federal funding agencies for adequate funding to conduct a properly powered randomized clinical trial. This pilot study will provide useful information for future sample size calculations and give some indication as to the rate of adverse reactions and safety profile of bupropion taken during pregnancy.
Cigarette smoking is associated with various complications of pregnancy., Likewise, infants and children of women who smoke during pregnancy are at greater risk for a myriad of physical and developmental problems. Women who participate in the study and receive the intervention may benefit if they reduce or stop their tobacco use. Decreased cigarette smoking by pregnant subjects enrolled in this study may lead to a reduction in complications of pregnancy and health problems of infants and children that are attributable to smoking.
The standard therapy for pregnant women is to receive some directive counseling from their clinician. Occasionally, patients will even be referred to community organizations to reinforce the office counseling. The evidence suggests that there is limited value to behavioral counseling alone and that most clinicians are not properly trained and that those who are, do not have the time to adequately counsel patients. There are no smoking cessation programs currently available in the Tucson community that offer pharmacologic assistance in combination with counseling to pregnant women. Individual clinicians do prescribe pharmacologic aids for their patients on a case by case basis.
Smoking cessation counseling is evidence based. However, as the investigators have previously indicated it is rarely conveyed to patients because of inadequate training and time. There is currently no support within obstetrical healthcare funding to subsidize the cost of this service.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Arizona
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Tucson, Arizona, United States, 85712
- Watching Over Mothers and Babies Foundation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Smoked at least one puff in the past 7 days
- Confirmed viable gestation
Exclusion Criteria:
- All patients found to have a non-viable fetus or major congenital anomaly
- History of seizure disorder
- Family history of seizure disorder
- History of severe head trauma
- History of anorexia nervosa or bulimia
- Current use of nicotine-replacement therapy
- Unstable medical or psychiatric condition
- Current use of an monoamine oxidase inhibitor or bupropion hydrochloride products
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Bupropion SR
Study medication (150 mg bupropion SR) daily for 14 days.
Women still smoking at 2-weeks & 4-weeks were encouraged to increase their medication to two times per day (150 mg bid).
Women received smoking cessation counseling at baseline, 2, 4, 6, and 8 weeks.
|
Comparison of bupropion SR or placebo + smoking cessation counseling
Other Names:
|
PLACEBO_COMPARATOR: Placebo
Study medication (placebo) daily for 14 days.
Women still smoking at 2-weeks & 4-weeks were encouraged to increase their medication to two times per day.
Women received smoking cessation counseling at baseline, 2, 4, 6, and 8 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
biologically verified smoking cessation or reduction
Time Frame: 8 weeks and delivery
|
change in smoking from study enrollment to end of treatment (8 weeks) and at delivery
|
8 weeks and delivery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
adverse events reported during pregnancy
Time Frame: 8 weeks and delivery
|
8 weeks and delivery
|
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self reported smoking cessation or reduction
Time Frame: 8 weeks and delivery
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change in self reported smoking from study enrollment to end of treatment (8 weeks) and at delivery
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8 weeks and delivery
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
depression
Time Frame: 8 weeks and delivery
|
change in depression (measured by the Edinburgh postnatal depression scale) between study enrollment and end of treatment (8 weeks)
|
8 weeks and delivery
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Hugh S Miller, MD, Watching Over Mothers and Babies Foundation
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Antidepressive Agents
- Dopamine Agents
- Cytochrome P-450 Enzyme Inhibitors
- Antidepressive Agents, Second-Generation
- Cytochrome P-450 CYP2D6 Inhibitors
- Dopamine Uptake Inhibitors
- Bupropion
Other Study ID Numbers
- 1R21CA089510-01A2 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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