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Bupropion for Smoking Cessation in Pregnancy

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ClinicalTrials.gov Identifier: NCT01875172
Recruitment Status : Completed
First Posted : June 11, 2013
Last Update Posted : June 11, 2013
Sponsor:
Collaborator:
University of Arizona
Information provided by (Responsible Party):
Hugh Miller, Watching Over Mothers & Babies Foundation

Brief Summary:
The purpose of this study is to determine whether bupropion SR increases cessation and/or smoking reduction among pregnant smokers.

Condition or disease Intervention/treatment Phase
Smoking Cessation Pregnancy Drug: Bupropion SR Drug: placebo Behavioral: smoking cessation counseling Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Smoking Cessation in Pregnancy: A Pilot Study Comparing Counseling With and Without Sustained-Release Bupropion
Study Start Date : October 2001
Actual Primary Completion Date : January 2004
Actual Study Completion Date : January 2004

Resource links provided by the National Library of Medicine


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.
Drug: Bupropion SR
Comparison of bupropion SR or placebo + smoking cessation counseling
Other Names:
  • Wellbutrin SR
  • Zyban SR

Behavioral: smoking cessation counseling
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.
Drug: placebo
Behavioral: smoking cessation counseling



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. adverse events reported during pregnancy [ Time Frame: 8 weeks and delivery ]
  2. self reported smoking cessation or reduction [ Time Frame: 8 weeks and delivery ]
    change in self reported smoking from study enrollment to end of treatment (8 weeks) and at delivery


Other Outcome Measures:
  1. 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)



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01875172


Locations
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United States, Arizona
Watching over Mothers and Babies Foundation
Tucson, Arizona, United States, 85712
Sponsors and Collaborators
Watching Over Mothers & Babies Foundation
University of Arizona
Investigators
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Principal Investigator: Hugh S Miller, MD Watching Over Mothers and Babies Foundation

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Responsible Party: Hugh Miller, Medical Director, Watching Over Mothers & Babies Foundation
ClinicalTrials.gov Identifier: NCT01875172     History of Changes
Other Study ID Numbers: 1R21CA089510-01A2 ( U.S. NIH Grant/Contract )
First Posted: June 11, 2013    Key Record Dates
Last Update Posted: June 11, 2013
Last Verified: June 2013
Keywords provided by Hugh Miller, Watching Over Mothers & Babies Foundation:
bupropion SR
randomized controlled trial
pregnancy
Additional relevant MeSH terms:
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Bupropion
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors