Double-blind, Placebo-Controlled Pilot Study of Bupropion to Promote Smoking Cessation During Pregnancy
This study is currently recruiting participants.
Verified February 2012 by The University of Texas Health Science Center, Houston
Sponsor:
The University of Texas Health Science Center, Houston
Collaborators:
M.D. Anderson Cancer Center
Larry C. Gilstrap, MD Center for Perinatal and Women's Health Research
The Center for Clinical and Translational Sciences (CCTS) Clinical Research Unit at The University of Texas Health Science Center at Houston
Information provided by (Responsible Party):
Angela Stotts, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT01286402
First received: January 25, 2011
Last updated: February 23, 2012
Last verified: February 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Smoking Cessation |
Drug: Bupropion SR |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Double-blind, Placebo-Controlled Pilot Study of Bupropion to Promote Smoking Cessation During Pregnancy |
Resource links provided by NLM:
Further study details as provided by The University of Texas Health Science Center, Houston:
Primary Outcome Measures:
- 7-day point prevalence smoking abstinence with cotinine validation at the end of treatment [ Time Frame: 1 week post treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Enrollment, retention and compliance rates [ Time Frame: 1 year (estimated) ] [ Designated as safety issue: No ]
- Continuous abstinence from end of treatment through the 2 week followup [ Time Frame: at two week followup visit ] [ Designated as safety issue: No ]
- Continuous abstinence from birth to 2nd week postpartum followup [ Time Frame: at 2nd week postpartum followup visit ] [ Designated as safety issue: No ]
- Self-reported reduction in number of cigarettes smoked per day [ Time Frame: at 1 week post treatment and at 2 week postpartum visit ] [ Designated as safety issue: No ]
- Maternal side effects [ Time Frame: during treatment, end of treatment and at 2 week postpartum visit ] [ Designated as safety issue: Yes ]
- Perinatal/neonatal outcomes [ Time Frame: at neonatal discharge from hospital following delivery ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 50 |
| Study Start Date: | April 2011 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Bupropion SR (sustained release)
Group receiving bupropion SR medication
|
Drug: Bupropion SR
Other Name: Zyban, Wellbutrin
|
| Placebo Comparator: Placebo |
Drug: Bupropion SR
Other Name: Zyban, Wellbutrin
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01286402
Contacts
| Contact: Angela Stotts, PhD | 713.500.7590 | Angela.L.Stotts@uth.tmc.edu |
| Contact: Maria Hutchinson, MS | 713.500.5850 | Maria.S.Keefer@uth.tmc.edu |
Locations
| United States, Texas | |
| University of Texas Health Science Center at Houston, Professional Building | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Angela Stotts, PhD 713-500-7590 Angela.L.Stotts@uth.tmc.edu | |
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
M.D. Anderson Cancer Center
Larry C. Gilstrap, MD Center for Perinatal and Women's Health Research
The Center for Clinical and Translational Sciences (CCTS) Clinical Research Unit at The University of Texas Health Science Center at Houston
Investigators
| Principal Investigator: | Angela L Stotts, PhD | The University of Texas Health Science Center, Houston |
More Information
No publications provided
| Responsible Party: | Angela Stotts, Associate Professor - Family Medicine, The University of Texas Health Science Center, Houston |
| ClinicalTrials.gov Identifier: | NCT01286402 History of Changes |
| Other Study ID Numbers: | HSC-MS-09-0681 |
| Study First Received: | January 25, 2011 |
| Last Updated: | February 23, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by The University of Texas Health Science Center, Houston:
|
Smoking cessation during pregnancy bupropion |
Additional relevant MeSH terms:
|
Smoking Habits Bupropion Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses |
Pharmacologic Actions Dopamine Uptake Inhibitors Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013