Nicotine DependenceGRANDNCT00934024
Impact of Varenicline on Blood-Oxygen-Level Dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Activation on Smokers
A study testing varenicline in people with Nicotine Dependence, run by Medical University of South Carolina at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Nicotine Dependence
- What is being tested?
- varenicline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Jan 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: Impact of Varenicline on Blood-Oxygen-Level Dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Activation on Smokers (GRAND)
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
- Nicotine Dependence
- Being tested
- varenicline
- Keywords
- nicotine dependence, tobacco, smoking
- Medical subject headings
- Tobacco Use Disorder, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vareniclineDrug
Also called Chantix
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.
| Study group | Role | What they receive |
|---|---|---|
| Abstinent | Other | 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.. Receives: Drug: varenicline |
| Non-abstinent | Other | 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. Receives: Drug: varenicline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2009 (estimated)
- Study startApr 2009
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karen Hartwell, M.D., Principal investigator, Medical Universtiy of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00934024
- Sponsor's protocol ID
- HR#18521
- Acronym
- GRAND
- Status last verified
- Dec 2018
- First submitted
- 6 Jul 2009
- Last updated
- 10 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Varenicline on Blood-Oxygen-Level Dependent (BOLD) Functional Magnetic Resonance Imaging (fMRI) Activation on Smokers (GRAND)
- ClinicalTrials.gov ID
- NCT00934024
- Acronym / sponsor ID
- GRAND / HR#18521
- Conditions
- Nicotine Dependence
- Keywords
- nicotine dependence, tobacco, smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 8 Jul 2009 (estimated)
- Results
- Posted 10 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abstinent | Other | Drug: vareniclineAll 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 | Other | Drug: vareniclineAll 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. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vareniclineAlso: ChantixParticipants 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. | Drug | Abstinent, Non-abstinent |
Primary outcome
Change in Post-Resist Craving
Time frame: 5 weeks
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Hartwell, M.D. principal investigator
Medical Universtiy of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing varenicline in people with Nicotine Dependence, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Post-Resist Craving (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2018.