Back to resultsImpact of Varenicline on Blood-Oxygen-Level Dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Activation on Smokers (GRAND)
Primary Purpose
Nicotine Dependence
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
varenicline
Sponsored by
About this trial
This is an interventional treatment trial for Nicotine Dependence focused on measuring nicotine dependence, tobacco, smoking
Eligibility Criteria
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:
- 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.
Sites / Locations
- Medical University of South Carolina
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Abstinent
Non-abstinent
Arm Description
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..
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00934024
First Posted
July 6, 2009
Last Updated
December 7, 2018
Sponsor
Medical University of South Carolina
1. Study Identification
Unique Protocol Identification Number
NCT00934024
Brief Title
Impact of Varenicline on Blood-Oxygen-Level Dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Activation on Smokers
Acronym
GRAND
Official Title
Impact of Varenicline on Blood-Oxygen-Level Dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Activation on Smokers (GRAND)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina
4. Oversight
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence
Keywords
nicotine dependence, tobacco, smoking
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Abstinent
Arm Type
Other
Arm Description
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..
Arm Title
Non-abstinent
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
varenicline
Other Intervention Name(s)
Chantix
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Post-Resist Craving
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Hartwell, M.D.
Organizational Affiliation
Medical Universtiy of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Impact of Varenicline on Blood-Oxygen-Level Dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Activation on Smokers
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