Bupropion for Smoking Cessation During Pregnancy - Full Text View

Purpose

This is a prospective, double-blind placebo-controlled randomized controlled trial of the preliminary safety and efficacy of bupropion SR in combination with behavioral counseling for smoking cessation during pregnancy.

Condition	Intervention	Phase
Pregnancy Related Tobacco Use Disorder	Drug: bupropion SR 150 mg tablets or matched placebo Behavioral: Smoking Cessation Counseling	Phase 4

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:	Bupropion for Smoking Cessation During Pregnancy

Resource links provided by NLM:

MedlinePlus related topics: Quitting Smoking Smoking

Drug Information available for: Bupropion hydrochloride Bupropion

U.S. FDA Resources

Further study details as provided by The University of Texas, Galveston:

Primary Outcome Measures:

Minnesota Nicotine Withdrawal Scale [ Time Frame: Completion of study therapy (12 wks study treatment) ] [ Designated as safety issue: No ]
The MNWS will be used to assess for change in withdrawal symptoms from the quit date (onset of smoking cessation + after 1 wk of treatment) to that at the completion of study therapy (status post 12 wks of study treatment, 11 wks post quit date).

Secondary Outcome Measures:

7-day point prevalence smoking abstinence [ Time Frame: 3 weeks post quit date (post 12 weeks of study therapy) ] [ Designated as safety issue: No ]
Abstinence, that is quit rate, measured via 7-day point prevalence abstinence will be assessed at the end of study medication treatment, that is post 12 weeks of study drug treatment and again at end of pregnancy (36.0-38.6 weeks of gestation). This outcome will be assessed twice to determine a change in the quit rate from immediately status post treatment to that which occurs immediately before delivery.
7-day point prevalence smoking abstinence [ Time Frame: 36.0-38.6 wks gestation ] [ Designated as safety issue: No ]
To assess change from immediately post treatment to that immediately prior to delivery.

Estimated Enrollment:	150
Study Start Date:	July 2011
Estimated Study Completion Date:	October 2015
Estimated Primary Completion Date:	October 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Bupropion SR Bupropion SR 150 mg po BID. We will administer a 12-week course of therapy, 150 mg bid x 12 weeks. Subjects will be dispensed a 30 day supply at a time. They will be instructed to begin using study medication (bupropion SR 150 mg orally for 3 days, then BID for 4 days) on study visit day 1, which will be approximately 1 week prior to their quit date. Thereafter, they will continue to dose BID for 12 full weeks of therapy.	Drug: bupropion SR 150 mg tablets or matched placebo Bupropion SR tablets or matched placebo. We will administer a 12-week course of therapy, 150 mg bid/placebo x 12 weeks. Subjects will be dispensed a 30 day supply at a time. They will be instructed to begin using study medication (bupropion SR 150 mg/matched placebo orally for 3 days, then BID for 4 days) on study visit day 1, which will be approximately 1 week prior to their quit date. Thereafter, they will continue to dose BID for 12 full weeks of therapy. Other Names: Zyban buproban Behavioral: Smoking Cessation Counseling The behavioral counseling will include 35-minute counseling sessions at each of the first 2 visits and 10 minutes of smoking cessation counseling at subsequent visits, provided by the study nurse. Other Name: behavioral counseling
Placebo Comparator: Placebo We will administer a 12-week course of therapy, placebo bid x 12 weeks. Subjects will be dispensed a 30 day supply at a time. They will be instructed to begin using study medication (matched placebo tablets orally for 3 days, then BID for 4 days) on study visit day 1, which will be approximately 1 week prior to their quit date. Thereafter, they will continue to dose BID for 12 full weeks of therapy.	Drug: bupropion SR 150 mg tablets or matched placebo Bupropion SR tablets or matched placebo. We will administer a 12-week course of therapy, 150 mg bid/placebo x 12 weeks. Subjects will be dispensed a 30 day supply at a time. They will be instructed to begin using study medication (bupropion SR 150 mg/matched placebo orally for 3 days, then BID for 4 days) on study visit day 1, which will be approximately 1 week prior to their quit date. Thereafter, they will continue to dose BID for 12 full weeks of therapy. Other Names: Zyban buproban Behavioral: Smoking Cessation Counseling The behavioral counseling will include 35-minute counseling sessions at each of the first 2 visits and 10 minutes of smoking cessation counseling at subsequent visits, provided by the study nurse. Other Name: behavioral counseling

Arms

Assigned Interventions

Active Comparator: Bupropion SR

Bupropion SR 150 mg po BID. We will administer a 12-week course of therapy, 150 mg bid x 12 weeks. Subjects will be dispensed a 30 day supply at a time. They will be instructed to begin using study medication (bupropion SR 150 mg orally for 3 days, then BID for 4 days) on study visit day 1, which will be approximately 1 week prior to their quit date. Thereafter, they will continue to dose BID for 12 full weeks of therapy.

Drug: bupropion SR 150 mg tablets or matched placebo

Bupropion SR tablets or matched placebo. We will administer a 12-week course of therapy, 150 mg bid/placebo x 12 weeks. Subjects will be dispensed a 30 day supply at a time. They will be instructed to begin using study medication (bupropion SR 150 mg/matched placebo orally for 3 days, then BID for 4 days) on study visit day 1, which will be approximately 1 week prior to their quit date. Thereafter, they will continue to dose BID for 12 full weeks of therapy.

Other Names:

Zyban
buproban

Behavioral: Smoking Cessation Counseling

The behavioral counseling will include 35-minute counseling sessions at each of the first 2 visits and 10 minutes of smoking cessation counseling at subsequent visits, provided by the study nurse.

Other Name: behavioral counseling

Placebo Comparator: Placebo

We will administer a 12-week course of therapy, placebo bid x 12 weeks. Subjects will be dispensed a 30 day supply at a time. They will be instructed to begin using study medication (matched placebo tablets orally for 3 days, then BID for 4 days) on study visit day 1, which will be approximately 1 week prior to their quit date. Thereafter, they will continue to dose BID for 12 full weeks of therapy.

Drug: bupropion SR 150 mg tablets or matched placebo

Bupropion SR tablets or matched placebo. We will administer a 12-week course of therapy, 150 mg bid/placebo x 12 weeks. Subjects will be dispensed a 30 day supply at a time. They will be instructed to begin using study medication (bupropion SR 150 mg/matched placebo orally for 3 days, then BID for 4 days) on study visit day 1, which will be approximately 1 week prior to their quit date. Thereafter, they will continue to dose BID for 12 full weeks of therapy.

Other Names:

Zyban
buproban

Behavioral: Smoking Cessation Counseling

The behavioral counseling will include 35-minute counseling sessions at each of the first 2 visits and 10 minutes of smoking cessation counseling at subsequent visits, provided by the study nurse.

Other Name: behavioral counseling

Detailed Description:

This is a prospective, double-blind placebo-controlled randomized controlled trial of the preliminary safety and efficacy of bupropion SR in combination with behavioral counseling for smoking cessation during pregnancy. A total of 150 pregnant smokers will receive medication (75) or placebo (75) for 12 weeks. Compassionate care/continuance of therapy will be available to pregnant subjects. Women who relapse to smoking postpartum will be offered an additional course of medication treatment. All subjects irregardless of adherence with 12 week study drug administration period and smoking habits during pregnancy will be followed through the duration of their pregnancy, delivery, and 6-month post partum period. Subject participation will begin between 13-26 wks of gestation and end 6 months postpartum. Participation will be ten (10) to thirteen(13)months in length.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

smoking at least 10 CPD prior to pregnancy and 5 CPD for the preceding 7 days
13-26 weeks gestation
≥18 years of age
able to speak English or Spanish
intent to carry pregnancy to term
stable residence.

Exclusion Criteria:

current illicit drug or alcohol abuse or dependence
twins or other multiple gestation
treatment for psychiatric disorder within the last 6 months
unstable medical problems (eg, hypertension (BP>140/90), preeclampsia, threatened abortion, hyperemesis gravidarum)
known congenital abnormality
seizure disorder
use of psychotropic medication
use of medication known to lower the seizure threshold
anorexia/bulimia
a personal history of closed head trauma with > 30 minutes of loss of consciousness or amnesia or resulting in skull fracture or subdural hematoma/brain contusion
use of any other smoking cessation treatment in the past 30 days
current enrollment in methadone treatment program

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01390246

Contacts

Contact: Margaret Zimmerle, RN	409-747-8234	mlzimmer@utmb.edu
Contact: Janet Brandon, MSN	409-747-1733	jbrando@utmb.edu

Locations

United States, Texas
University of Texas Medical Branch at Galveston	Recruiting
Galveston, Texas, United States, 77555
Contact: Margaret Zimmerle, RN mlzimmer@utmb.edu
Principal Investigator: Gary DV Hankins, MD
Principal Investigator: Tatiana Nanovskaya, PhD

Sponsors and Collaborators

The University of Texas, Galveston

National Institute on Drug Abuse (NIDA)

University of Connecticut Health Center

Investigators

Principal Investigator:	Gary DV Hankins, MD	University of Texas Medical Branch at Galveston
Principal Investigator:	Tatiana Nanovskaya, PhD	University of Texas Medical Branch at Galveston

More Information

No publications provided

Responsible Party:	The University of Texas, Galveston
ClinicalTrials.gov Identifier:	NCT01390246 History of Changes
Other Study ID Numbers:	10-217, R01DA030998-02
Study First Received:	June 8, 2011
Last Updated:	March 27, 2013
Health Authority:	United States: Institutional Review Board United States: Federal Government

Keywords provided by The University of Texas, Galveston:

Pregnancy
Tobacco use disorder
Smoking cessation
Bupropion SR
Zyban

Additional relevant MeSH terms:

Tobacco Use Disorder
Smoking
Habits
Substance-Related Disorders
Mental Disorders
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 19, 2013