Smoking CessationPhase 2NCT01286402
Double-blind, Placebo-Controlled Pilot Study of Bupropion to Promote Smoking Cessation During Pregnancy
A Phase 2 study testing Bupropion SR in people with Smoking Cessation, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Bupropion SR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to May 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant women ≥ 18 years of age
- Gestational age between 14 and 26 weeks confirmed by ultrasound
- Currently smoking ≥ 5 cigarettes per day
Who cannot join
- 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
Show all 16Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center at Houston, Professional Building
Houston, Texas, 77030
About this study
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.
Read the 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.
- Conditions
- Smoking Cessation
- Being tested
- Bupropion SR, Placebo
- Keywords
- Smoking cessation during pregnancy, bupropion
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupropion SRDrug
Also called Zyban, Wellbutrin
- 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
PlaceboOther
-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
| Study group | Role | What they receive |
|---|---|---|
| Bupropion SR (sustained release) | Experimental | Group receiving bupropion SR medication Receives: Drug: Bupropion SR |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-day Point Prevalence Smoking Abstinence With Cotinine Validation at the End of Treatment
Measured: 1 week post treatment
Secondary outcomes (6)
Enrollment, Retention and Compliance Rates
Measured: 1 year (estimated)
Continuous Abstinence From End of Treatment Through the 2 Week Followup
Measured: at two week followup visit
Continuous Abstinence From Birth to 2nd Week Postpartum Followup
Measured: at 2nd week postpartum followup visit
Self-reported Reduction in Number of Cigarettes Smoked Per Day
Measured: at 1 week post treatment and at 2 week postpartum visit
Maternal Side Effects
Measured: during treatment, end of treatment and at 2 week postpartum visit
Perinatal/Neonatal Outcomes
Measured: at neonatal discharge from hospital following delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2011 (estimated)
- Study startApr 2011
- Primary completionOct 2012
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Principal investigator, Angela Stotts, The University of Texas Health Science Center, Houston
- Investigators
- Angela L Stotts, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01286402
- Sponsor's protocol ID
- HSC-MS-09-0681
- Status last verified
- Jan 2016
- First submitted
- 25 Jan 2011
- Last updated
- 4 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Placebo-Controlled Pilot Study of Bupropion to Promote Smoking Cessation During Pregnancy
- ClinicalTrials.gov ID
- NCT01286402
- Acronym / sponsor ID
- HSC-MS-09-0681
- Conditions
- Smoking Cessation
- Keywords
- Smoking cessation during pregnancy, bupropion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- 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
- Study start
- Apr 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 31 Jan 2011 (estimated)
- Results
- Posted 4 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupropion SR (sustained release) | Experimental | Drug: Bupropion SRGroup receiving bupropion SR medication |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pregnant women ≥ 18 years of age
- Gestational age between 14 and 26 weeks confirmed by ultrasound
- Currently smoking ≥ 5 cigarettes per day
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupropion SRAlso: Zyban, Wellbutrin* 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 | Drug | Bupropion SR (sustained release) |
| 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 | Other | Placebo |
Primary outcome
7-day Point Prevalence Smoking Abstinence With Cotinine Validation at the End of Treatment
Time frame: 1 week post treatment
6 secondary outcomes
Enrollment, Retention and Compliance Rates
Time frame: 1 year (estimated)
Continuous Abstinence From End of Treatment Through the 2 Week Followup
Time frame: at two week followup visit
Continuous Abstinence From Birth to 2nd Week Postpartum Followup
Time frame: at 2nd week postpartum followup visit
Self-reported Reduction in Number of Cigarettes Smoked Per Day
Time frame: at 1 week post treatment and at 2 week postpartum visit
Maternal Side Effects
Time frame: during treatment, end of treatment and at 2 week postpartum visit
Perinatal/Neonatal Outcomes
Time frame: at neonatal discharge from hospital following delivery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angela L Stotts, PhD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bupropion SR in people with Smoking Cessation, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
7-day Point Prevalence Smoking Abstinence With Cotinine Validation at the End of Treatment (time frame: 1 week post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2016.