NCT01286402

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 31, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

February 4, 2016

Completed
Last Updated

February 4, 2016

Status Verified

January 1, 2016

Enrollment Period

1.5 years

First QC Date

January 25, 2011

Results QC Date

June 30, 2015

Last Update Submit

January 5, 2016

Conditions

Smoking Cessation

Keywords

Smoking cessation during pregnancybupropion

Outcome Measures

Primary Outcomes (1)

  • 7-day Point Prevalence Smoking Abstinence With Cotinine Validation at the End of Treatment

    1 week post treatment

Secondary Outcomes (6)

  • Enrollment, Retention and Compliance Rates

    1 year (estimated)

  • 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

  • Self-reported Reduction in Number of Cigarettes Smoked Per Day

    at 1 week post treatment and at 2 week postpartum visit

  • Maternal Side Effects

    during treatment, end of treatment and at 2 week postpartum visit

  • +1 more secondary outcomes

Study Arms (2)

Bupropion SR (sustained release)

EXPERIMENTAL

Group receiving bupropion SR medication

Drug: Bupropion SR

Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

Bupropion SRDRUG

* 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

Also known as: Zyban, Wellbutrin
Bupropion SR (sustained release)
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

Placebo

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant women ≥ 18 years of age
  • Gestational age between 14 and 26 weeks confirmed by ultrasound
  • Currently smoking ≥ 5 cigarettes per day

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Health Science Center at Houston, Professional Building

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Interventions

Bupropion

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

PropiophenonesKetonesOrganic Chemicals

Results Point of Contact

Title
Angela Stotts, PhD, PI
Organization
University of Texas Health Science Center at Houston
Angela.L.Stotts@uth.tmc.edu
713-500-7590

Study Officials

  • Angela L Stotts, PhD

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor - Family Medicine

Study Record Dates

First Submitted

January 25, 2011

First Posted

January 31, 2011

Study Start

April 1, 2011

Primary Completion

October 1, 2012

Study Completion

May 1, 2013

Last Updated

February 4, 2016

Results First Posted

February 4, 2016

Record last verified: 2016-01

Locations

US(1)