Trial Outcomes & Findings for Impact of Varenicline on Blood-Oxygen-Level Dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Activation on Smokers (NCT NCT00934024)

Last Updated: 2018-12-10

Results Overview

Change in Post-resist task craving between Scan 1, pre-medication, and Scan 2, post- medication, as measured on a 0-10 Likert scale. The Within Sessions Rating scale (Range 0-10) measures craving with 0 indicating Not at All and 10 indicating Extremely. Change scores were calculate by subtracting the craving score immediately following the pre-medication scan from the craving score immediately following the post-medication scan.

Recruitment status

COMPLETED

Study phase

Target enrollment

21 participants

Primary outcome timeframe

5 weeks

Results posted on

2018-12-10

Participant Flow

Right-handed nicotine dependent cigarette smokers between 21 and 60 years of age were recruited via community and internet advertisements. Recruitment took place between 2009 and 2011.

All participants received open-label varenicline. Participants data was anaylzed in two groups- abstinent and non-abstinent participants.

Participant milestones

Participant milestones
Measure	Abstinent All participants received varenicline. A priori determined analysis was between participants who quit smoking and those who continued to smoke. This arm was abstinent after 5 weeks of varenicline treatment.	Non-abstinent All participants received varenicline. A priori determined analysis was between participants who quit smoking and those who continued to smoke. This arm was people who continued to smoke after 5 weeks of varenicline treatment.
Overall Study STARTED	10	11
Overall Study COMPLETED	10	6
Overall Study NOT COMPLETED	0	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Impact of Varenicline on Blood-Oxygen-Level Dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Activation on Smokers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Abstinent n=10 Participants All participants received varenicline. A priori determined analysis was between participants who quit smoking and those who continued to smoke. This arm was abstinent after 5 weeks of varenicline treatment.	Non-Abstinent n=11 Participants All participants received varenicline. A priori determined analysis was between participants who quit smoking and those who continued to smoke. This arm was participants who continued to smoke after 5 weeks of varenicline treatment.	Total n=21 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	24.8 Years STANDARD_DEVIATION 13.07 • n=5 Participants	35.55 Years STANDARD_DEVIATION 11.72 • n=7 Participants	30.18 Years STANDARD_DEVIATION 12.4 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	11 participants n=7 Participants	21 participants n=5 Participants
cigarettes per day	20.45 Cigarettes per day STANDARD_DEVIATION 5.83 • n=5 Participants	17.27 Cigarettes per day STANDARD_DEVIATION 4.29 • n=7 Participants	18.86 Cigarettes per day STANDARD_DEVIATION 5.06 • n=5 Participants

PRIMARY outcome

Timeframe: 5 weeks

Outcome measures

Outcome measures
Measure	Abstinent n=10 Participants All participants received varenicline. A priori determined analysis was between participants who quit smoking and those who continued to smoke. This arm was abstinent after 5 weeks of varenicline treatment.. varenicline: Participants will be treated with a standard course of varenicline, 0.5 mg 1 tablet every day for 3 days, then 0.5 mg 1 tab twice a day for four days, and 1 mg 1 tablet twice a day for three months.	Non-abstinent n=6 Participants All participants received varenicline. A priori determined analysis was between participants who quit smoking and those who continued to smoke. This arm was participants who continued to smoke after 5 weeks of varenicline treatment. varenicline: Participants will be treated with a standard course of varenicline, 0.5 mg 1 tablet every day for 3 days, then 0.5 mg 1 tab twice a day for four days, and 1 mg 1 tablet twice a day for three months.
Change in Post-Resist Craving	6 units on a scale Standard Deviation 1.41	3.6 units on a scale Standard Deviation 1.14

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	All Participants n=21 participants at risk All participants received varenicline. A priori determined analysis was between participants who quit smoking and those who continued to smoke. Adverse events are reported for the total of all participants. Since all patients received medication, DSMB reports were made in aggregate and are reported as such here.
Skin and subcutaneous tissue disorders Localized rash	4.8% 1/21 • Number of events 1 • AE's were collected over 5 weeks post medication administration.
General disorders Head, Eyes, Ears, Nose, Throat	38.1% 8/21 • Number of events 8 • AE's were collected over 5 weeks post medication administration.
Gastrointestinal disorders Gastrointestinal	47.6% 10/21 • Number of events 10 • AE's were collected over 5 weeks post medication administration.
General disorders Sleep Related	52.4% 11/21 • Number of events 11 • AE's were collected over 5 weeks post medication administration.
Psychiatric disorders Psychiatric	14.3% 3/21 • Number of events 3 • AE's were collected over 5 weeks post medication administration.
Vascular disorders Peripheral vascular	9.5% 2/21 • Number of events 2 • AE's were collected over 5 weeks post medication administration.
General disorders General	23.8% 5/21 • Number of events 5 • AE's were collected over 5 weeks post medication administration.

Additional Information

Dr. Karen Hartwell

MUSC

Phone: 843-792-8174

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place