NCT01875172

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
135

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2001

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

Study Start

First participant enrolled

October 1, 2001

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2004

Completed
9.3 years until next milestone

First Submitted

Initial submission to the registry

April 14, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 11, 2013

Completed
Last Updated

June 11, 2013

Status Verified

June 1, 2013

Enrollment Period

2.3 years

First QC Date

April 14, 2013

Last Update Submit

June 10, 2013

Conditions

Smoking CessationPregnancy

Keywords

bupropion SRrandomized controlled trialpregnancy

Outcome Measures

Primary Outcomes (1)

  • biologically verified smoking cessation or reduction

    change in smoking from study enrollment to end of treatment (8 weeks) and at delivery

    8 weeks and delivery

Secondary Outcomes (2)

  • adverse events reported during pregnancy

    8 weeks and delivery

  • self reported smoking cessation or reduction

    8 weeks and delivery

Other Outcomes (1)

  • depression

    8 weeks and delivery

Study Arms (2)

Bupropion SR

EXPERIMENTAL

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 SRBehavioral: smoking cessation counseling

Placebo

PLACEBO COMPARATOR

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: placeboBehavioral: smoking cessation counseling

Interventions

Bupropion SRDRUG

Comparison of bupropion SR or placebo + smoking cessation counseling

Also known as: Wellbutrin SR, Zyban SR
Bupropion SR
placeboDRUG
Placebo
smoking cessation counselingBEHAVIORAL
Bupropion SRPlacebo

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Smoked at least one puff in the past 7 days
  • Confirmed viable gestation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Watching over Mothers and Babies Foundation

Tucson, Arizona, 85712, United States

Location

Related Publications (1)

  • Hajizadeh A, Howes S, Theodoulou A, Klemperer E, Hartmann-Boyce J, Livingstone-Banks J, Lindson N. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2023 May 24;5(5):CD000031. doi: 10.1002/14651858.CD000031.pub6.

    PMID: 37230961DERIVED

MeSH Terms

Conditions

Smoking Cessation

Interventions

Bupropion

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

PropiophenonesKetonesOrganic Chemicals

Study Officials

  • Hugh S Miller, MD

    Watching Over Mothers and Babies Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director

Study Record Dates

First Submitted

April 14, 2013

First Posted

June 11, 2013

Study Start

October 1, 2001

Primary Completion

January 1, 2004

Study Completion

January 1, 2004

Last Updated

June 11, 2013

Record last verified: 2013-06

Locations

US(1)