Trial Outcomes & Findings for Effects of Varenicline on Cigarette Self Administration (NCT NCT00731055)

NCT ID: NCT00731055

Last Updated: 2018-06-18

Results Overview

Over each of the four 6-hour experimental sessions, a participant was asked 9 times if they would take money or a cigarette. This outcome measure assesses the number of times a participant chose a cigarette.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 16 participants
• Primary outcome timeframe: During each of the four weekly 6-hour experimental sessions
• Results posted on: 2018-06-18

Participant Flow

Twenty-one participants were recruited in an urban hospital setting through advertisement in local newspapers and flyers and 16 particiopants were enrolled. Study was conducted at the NYS Psychiatric Institute

Participant milestones

Measure	Study Participants This is a within-group study design, all participant who completed the study receive all 4 experimental treatments
Overall Study STARTED	16
Overall Study Received Placebo	16
Overall Study Received Varenicline 0.5 mg	16
Overall Study Received Varenicline 1.0 mg	16
Overall Study Received Varenicline 2.0 mg	16
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Varenicline on Cigarette Self Administration

Baseline characteristics by cohort

Measure	Study Participants n=16 Participants Each of study participants received one dose of study medication (varenicline 0mg, 0.5mg, 1mg, and 2 mg) before each of the experimental sessions at least 5 days apart.
Age, Continuous	36.5 years n=93 Participants
Sex: Female, Male Female	4 Participants n=93 Participants
Sex: Female, Male Male	12 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	10 Participants n=93 Participants
Race (NIH/OMB) White	6 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	16 participants n=93 Participants

PRIMARY outcome

Timeframe: During each of the four weekly 6-hour experimental sessions

Over each of the four 6-hour experimental sessions, a participant was asked 9 times if they would take money or a cigarette. This outcome measure assesses the number of times a participant chose a cigarette.

Outcome measures

Measure	Placebo n=16 Participants The outcome of the session during which participant received placebo	Varenicline 0.5 mg n=16 Participants The outcome of the session during which participant received varenicline 0.5 mg	Varenicline 1.0 mg n=16 Participants The outcome of the session during which participant received varenicline 1.0 mg	Varenicline 2.0 mg n=16 Participants The outcome of the session during which participant received varenicline 2.0 mg
Cigarette Choice	3.67 number of cigarette choices (0-9) Standard Deviation 0.51	3.17 number of cigarette choices (0-9) Standard Deviation 0.63	2.83 number of cigarette choices (0-9) Standard Deviation 0.71	2.83 number of cigarette choices (0-9) Standard Deviation 0.55

Adverse Events

Study Participants

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

Dr. Adam Bisaga

New York State Psychiatric Institute

Phone: 646-774-6155

Email: amb107@columbia.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place