CompletedNCT00934024GRANDUpdated Dec 10, 2018Results posted

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

An interventional study of varenicline in Nicotine Dependence, sponsored by Medical University of South Carolina. Completed at 1 site in United States. Open to participants aged 21 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-12-10.

Sponsored by Medical University of South Carolina · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 21
Allocation: Non-randomized
Ages: 21 Years to 60 Years
Sex: All

Study summary

The purpose of this study is to evaluate the impact of varenicline treatment on cue induced craving to smoking using brain imaging. The investigators hypothesize that participants will report reduced urges to smoke and will have less activation in parts of the brain associated with craving.

Read the detailed description

Treatment with varenicline reduces overall subjective cigarette craving and smoking reward in nicotine-dependent smokers. This preliminary study will explore the impact of varenicline treatment on smoking cue-induced craving and associated regional brain activation using BOLD fMRI. Twenty healthy smokers (10 males, 10 females) will undergo two BOLD fMRI scans with the presentation of smoking-related and neutral cues at baseline and after five weeks of treatment with open-label varenicline. The investigators hypothesize that participants will report reduced urges to smoke on the Questionnaire of Smoking Urges-Brief and have less activation of the brain areas associated with craving during the fMRI after 5 weeks of varenicline and smoking cessation counseling compared to the baseline scan.

Conditions studied

Nicotine Dependence

Browse trials for

Tobacco Use Disorder 968

Keywords

nicotine dependence
tobacco
smoking

In context

Tobacco Use Disorder

968 studies on the registry are indexed under Tobacco Use Disorder; 126 are open to participants now.

This study's enrollment of 21 is below the median of 89 across 851 interventional studies indexed under Tobacco Use Disorder.

Browse Tobacco Use Disorder studies →

Lead sponsor

Medical University of South Carolina is the lead sponsor of 852 studies on the registry; 165 are open to participants now.

Of its 128 completed or terminated interventional studies of FDA-regulated products, 101 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 21 Years to 60 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Age 21 - 60 treatment-seeking right handed smokers.
Meet criteria for primary nicotine dependence confirmed by FTND and smoked at least 70% of days in the last 30 days prior to assessment.
General good health confirmed by history \& physical.
Able to read and understand questionnaires and informed consent.
Motivated to quit, willing to set a target quit date (TQD) and abstain from smoking after TDQ.
Participants must have a negative urine drug screen (UDS) and pregnancy test prior to imaging sessions and beginning varenicline treatment.
Female participants will use a reliable method of birth control throughout the study.
Demonstrate subjective response to cues in a laboratory cue reactivity session.

Exclusion criteria

Exclusion Criteria:

Currently meets DSM-IV criteria for any other psychoactive substance dependence disorder except nicotine dependence.
Any psychoactive substance abuse within the last 30 days as evidenced by subject report or urine drug screen.
Use of other tobacco products.
Current use of nicotine replacement therapy, bupropion, or other smoking cessation treatment.
Previous failed attempt on varenicline.
Meets DSM-IV criteria for current axis I disorders of major depression, panic disorder, obsessive compulsive disorder, post-traumatic stress syndrome, bipolar affective disorder, schizophrenia, or any other psychotic disorder or organic mental disorder.
Current suicidal ideation with plan or homicidal ideation.
Need for maintenance or acute treatment with any psychoactive medication including anti-seizure medications which could potentially interfere with fMRI.
Clinically significant medical problems that would impair participation or limit ability to participate in scan.
Sexually active females of child-bearing potential who are pregnant, nursing, or who are not using a reliable form of birth control.
Has current charges pending for a violent crime (not including DUI related offenses).
Persons with ferrous metal implants or pacemaker since fMRI will be used.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Single group
Masking: None (open label)
Enrollment: 21 participants (actual)

Study arms

Other
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..
Drug: varenicline
Other
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 participants who continued to smoke after 5 weeks of varenicline treatment.
Drug: varenicline

Interventions

Drugvarenicline
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.
Also known as: Chantix

What researchers measure

Primary outcomes

Change in Post-Resist Craving
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.
Time frame: 5 weeks

Results

Posted Dec 10, 2018

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.

Participant flow — Overall Study
Milestone	Abstinent	Non-abstinent
Started	10	11
Completed	10	6
Not completed	0	5

Outcome measures

PrimaryChange in Post-Resist Craving

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.

Time frame:: 5 weeks
Reported as:: Mean · units on a scale

Change in Post-Resist Craving
units on a scale	Abstinent	Non-abstinent
Change in Post-Resist Craving	6 ± 1.41	3.6 ± 1.14

Adverse events

Collected over AE's were collected over 5 weeks post medication administration.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
All Participants	0/21 (0%)	0/21 (0%)	16/21 (76.2%)

Most frequent other events

Most frequent other events
Event	All Participants
Sleep RelatedGeneral disorders	11/21
GastrointestinalGastrointestinal disorders	10/21
Head, Eyes, Ears, Nose, ThroatGeneral disorders	8/21
GeneralGeneral disorders	5/21
PsychiatricPsychiatric disorders	3/21
Peripheral vascularVascular disorders	2/21
Localized rashSkin and subcutaneous tissue disorders	1/21

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Abstinent	Non-Abstinent	Total
<=18 years	0	0	0
Between 18 and 65 years	10	11	21
>=65 years	0	0	0

Age, Continuous
Age, Continuous(Years)	Abstinent	Non-Abstinent	Total
Mean	24.8 ± 13.07	35.55 ± 11.72	30.18 ± 12.4

Sex: Female, Male
Sex: Female, Male(Participants)	Abstinent	Non-Abstinent	Total
Female	3	6	9
Male	7	5	12

Region of Enrollment
Region of Enrollment(participants)	Abstinent	Non-Abstinent	Total
United States	10	11	21

cigarettes per day
cigarettes per day(Cigarettes per day)	Abstinent	Non-Abstinent	Total
Mean	20.45 ± 5.83	17.27 ± 4.29	18.86 ± 5.06

Study locations

1 site

Medical University of South Carolina
Charleston, South Carolina 29425, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 10, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00934024
Lead sponsor: Medical University of South Carolina
Responsible party: Sponsor
First posted: Jul 8, 2009
Start date: Apr 2009
Primary completion: Jan 2012
Completion: Jan 2012
Results posted: Dec 10, 2018
Last update: Dec 10, 2018

Study contacts

Karen Hartwell, M.D.

principal investigator · Medical Universtiy of South Carolina

View the source record on ClinicalTrials.gov ↗

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