Trial Outcomes & Findings for Double-blind, Placebo-Controlled Pilot Study of Bupropion to Promote Smoking Cessation During Pregnancy (NCT NCT01286402)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

11 participants

Primary outcome timeframe

1 week post treatment

Results posted on

2016-02-04

Participant Flow

Participant milestones

Participant milestones
Measure	Bupropion SR (Sustained Release) Group receiving bupropion SR medication Bupropion SR: - 150mg (1 pill), taken orally, taken daily for the 1st 3 days \- 300mg (2 pills), taken orally, taken daily for the rest of the 8 weeks of drug treatment	Placebo Group receiving 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
Overall Study STARTED	5	6
Overall Study COMPLETED	5	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Double-blind, Placebo-Controlled Pilot Study of Bupropion to Promote Smoking Cessation During Pregnancy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bupropion SR (Sustained Release) n=5 Participants Group receiving bupropion SR medication Bupropion SR: - 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	Placebo n=6 Participants Group receiving 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	Total n=11 Participants Total of all reporting groups
Age, Continuous	27.2 years STANDARD_DEVIATION 5.6 • n=5 Participants	26.7 years STANDARD_DEVIATION 5.9 • n=7 Participants	26.9 years STANDARD_DEVIATION 5.5 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	6 participants n=7 Participants	11 participants n=5 Participants
# cigs smoked in past 30 days	10.8 cigarettes STANDARD_DEVIATION 11.1 • n=5 Participants	10.7 cigarettes STANDARD_DEVIATION 5.4 • n=7 Participants	10.7 cigarettes STANDARD_DEVIATION 8.0 • n=5 Participants
Age started smoking	17.8 years STANDARD_DEVIATION 3.0 • n=5 Participants	17.3 years STANDARD_DEVIATION 9.0 • n=7 Participants	17.5 years STANDARD_DEVIATION 4.3 • n=5 Participants
Carbon monoxide reading	8.8 parts per million STANDARD_DEVIATION 3.7 • n=5 Participants	15.2 parts per million STANDARD_DEVIATION 17.5 • n=7 Participants	12.0 parts per million STANDARD_DEVIATION 12.4 • n=5 Participants

PRIMARY outcome

Timeframe: 1 week post treatment

Outcome measures

Outcome measures
Measure	Bupropion SR (Sustained Release) n=5 Participants Group receiving bupropion SR medication Bupropion SR: - 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	Placebo n=6 Participants Group receiving 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
7-day Point Prevalence Smoking Abstinence With Cotinine Validation at the End of Treatment	0 participants	2 participants

SECONDARY outcome

Timeframe: 1 year (estimated)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: at two week followup visit

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: at 2nd week postpartum followup visit

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: at 1 week post treatment and at 2 week postpartum visit

Outcome measures

Outcome data not reported

SECONDARY outcome

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: at neonatal discharge from hospital following delivery

Outcome measures

Outcome data not reported

Adverse Events

Bupropion SR (Sustained Release)

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Bupropion SR (Sustained Release) n=5 participants at risk Group receiving bupropion SR medication Bupropion SR: - 150mg (1 pill), taken orally, taken daily for the 1st 3 days \- 300mg (2 pills), taken orally, taken daily for the rest of the 8 weeks of drug treatment	Placebo n=6 participants at risk Group receiving 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
Respiratory, thoracic and mediastinal disorders Newborn readmission for respiratory failure on day of life 5	20.0% 1/5 • Number of events 1	0.00% 0/6
Hepatobiliary disorders Hyperbilirubinemia secondary to ABO incompatibility	20.0% 1/5 • Number of events 1	0.00% 0/6

Other adverse events

Other adverse events
Measure	Bupropion SR (Sustained Release) n=5 participants at risk Group receiving bupropion SR medication Bupropion SR: - 150mg (1 pill), taken orally, taken daily for the 1st 3 days \- 300mg (2 pills), taken orally, taken daily for the rest of the 8 weeks of drug treatment	Placebo n=6 participants at risk Group receiving 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
Gastrointestinal disorders Vomiting	40.0% 2/5 • Number of events 2	0.00% 0/6
General disorders Dry mouth	20.0% 1/5 • Number of events 1	0.00% 0/6
Nervous system disorders Agitation	0.00% 0/5	16.7% 1/6 • Number of events 1
Gastrointestinal disorders nausea	40.0% 2/5 • Number of events 2	33.3% 2/6 • Number of events 2

Additional Information

Angela Stotts, PhD, PI

University of Texas Health Science Center at Houston

Phone: 713-500-7590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place