Trial Outcomes & Findings for Human Laboratory Study of Varenicline and Bupropion for Nicotine Dependence (NCT NCT00749658)

Results Overview

Subjects were analyzed by how they self reported withdrawal or craved cigarettes during treatment Subjects self reported during study visits along with surveys

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

121 participants

Primary outcome timeframe

Change from Base line to 33 weeks

Results posted on

2020-11-23

Participant Flow

Participant milestones

Participant milestones
Measure	Bupropion + Placebo Varenicline Order 1: Bupropion + Placebo Varenicline \\Varenicline + Placebo Bupropion; Order 2: Varenicline + Placebo Bupropion \\Bupropion + Placebo Varenicline Bupropion SR: Form: tablet, Dosage, Frequency, Duration: Days 1-3, 150 mg, q.d., Days 4-11, 150 mg, b.i.d. Varenicline: Form: tablet, Dosage, Frequency, Duration: Days 1-3, .5 mg, q.d., Days 4-7, .5 mg, b.i.d., Days 8-11, 1 mg, b.i.d.	Varenicline + Placebo Bupropion Order 1: Bupropion + Varenicline \\Varenicline + Placebo Bupropion; Order 2: Varenicline + Placebo Bupropion \\Bupropion + Varenicline Bupropion SR: Form: tablet, Dosage, Frequency, Duration: Days 1-3, 150 mg, q.d., Days 4-11, 150 mg, b.i.d. Varenicline: Form: tablet, Dosage, Frequency, Duration: Days 1-3, .5 mg, q.d., Days 4-7, .5 mg, b.i.d., Days 8-11, 1 mg, b.i.d.
Overall Study STARTED	60	61
Overall Study COMPLETED	60	61
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Human Laboratory Study of Varenicline and Bupropion for Nicotine Dependence

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Bupropion + Placebo Varenicline n=60 Participants Order 1: Bupropion + Placebo Varenicline \\Varenicline + Placebo Bupropion; Order 2: Varenicline + Placebo Bupropion \\Bupropion + Placebo Varenicline Bupropion SR: Form: tablet, Dosage, Frequency, Duration: Days 1-3, 150 mg, q.d., Days 4-11, 150 mg, b.i.d. Varenicline: Form: tablet, Dosage, Frequency, Duration: Days 1-3, .5 mg, q.d., Days 4-7, .5 mg, b.i.d., Days 8-11, 1 mg, b.i.d.	Upropion + Varenicline n=61 Participants Order 1: Bupropion + Varenicline \\Varenicline + Placebo Bupropion; Order 2: Varenicline + Placebo Bupropion \\Bupropion + Varenicline Bupropion SR: Form: tablet, Dosage, Frequency, Duration: Days 1-3, 150 mg, q.d., Days 4-11, 150 mg, b.i.d. Varenicline: Form: tablet, Dosage, Frequency, Duration: Days 1-3, .5 mg, q.d., Days 4-7, .5 mg, b.i.d., Days 8-11, 1 mg, b.i.d.	Total n=121 Participants Total of all reporting groups
Age, Continuous	39.5 years STANDARD_DEVIATION 11.2 • n=5 Participants	40.2 years STANDARD_DEVIATION 11.3 • n=7 Participants	39.85 years STANDARD_DEVIATION 11.25 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants	31 Participants n=7 Participants	61 Participants n=5 Participants
Race/Ethnicity, Customized White	56 Count of particpants n=5 Participants	52 Count of particpants n=7 Participants	108 Count of particpants n=5 Participants
Region of Enrollment United States	60 participants n=5 Participants	61 participants n=7 Participants	121 participants n=5 Participants

PRIMARY outcome

Timeframe: Change from Base line to 33 weeks

Population: All efforts were made to contact the PI/study team members, but were unsuccessful. No outcome measure study data are available.

Subjects were analyzed by how they self reported withdrawal or craved cigarettes during treatment Subjects self reported during study visits along with surveys

Outcome measures

Outcome data not reported

Adverse Events

Bupropion + Placebo Varenicline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Varenicline + Placebo Bupropion

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Marc Mooney PhD

University of Minnesota

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place