Effects of Varenicline on Brain Activity During Nicotine Abstinence
NCT00602927
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
1. Treatment-seeking smokers between the ages of 18 and 65, that smoke at least 10 cigarettes/day for at least the past 6 months
2. Provide a baseline CO (carbon monoxide) reading of >10ppm
3. Provide written informed consent and are fluent, English-speaking
4. Weight of equal to or less than 300 lbs
Smoking Behavior
1. Use of chewing tobacco, snuff or cigars
2. Current enrollment or plans to enroll in another smoking cessation program in the next
5 months
3. Plan to use other nicotine substitutes or smoking cessation treatments in the next 5
months
4. Provide a baseline CO (carbon monoxide) reading ≤10 ppm
Alcohol/Drug Exclusion Criteria
1. History of substance abuse and/or currently receiving treatment for substance abuse
2. Current alcohol consumption that exceeds 25 standard drinks/week
3. A breath alcohol concentration reading ≥ 0.01 at the H&P (health & physical) screening
or either of the lab sessions
Medication Exclusion Criteria
1. Prior use of Chantix
2. Current use or recent discontinuation (within last 14-days) of the following
medications:
1. Any form of smoking cessation medication
2. Any form of anti-psychotic medications that includes:
- antipsychotics,
- atypical antipsychotics,
- mood-stabilizers,
- anti-depressants (tricyclic, SSRI, MAOI),
- anti-panic agents,
- anti-obsessive agents,
- anti-anxiety agents, and
- stimulants (e.g., Provigil, Ritalin)
- herbal medications (St. John's Wort)
3. Opioid medication for chronic pain
4. Anti-coagulants
5. Any heart medications
6. Daily medication for asthma
Medical Exclusion Criteria
1. Women who are pregnant, planning a pregnancy, or lactating;
2. History or current diagnosis of psychosis, current major depression, bipolar disorder,
ADHD, schizophrenia, or any Axis 1 disorder as identified by the MINI
3. Serious or unstable disease within the past 6 months (heart disease, HIV)
4. Diagnosis of cancer in the past 6 months or if successful treatment for cancer has not
ended within the past 6 months
5. History of epilepsy or a seizure disorder
6. History or current diagnosis (last 6-months) of abnormal rhythms and/or tachycardia
(>100 beats/minute); history or current diagnosis of COPD (chronic obstructive
pulmonary disease), cardiovascular disease (stroke, angina, coronary heart disease),
heart attack in the last 6 months, uncontrolled hypertension (SBP>150 or DBP>90)
7. History of kidney and/or liver failure (including transplant)
8. History of head trauma or prior seizure; family history of a seizure disorder, brain
(or central nervous system) tumor
9. Use of pacemakers, certain metallic implants, or presence of metal in the eye as
contraindicated for MRI (magnetic resonance imaging);
10. Low or borderline intellectual functioning - determined by receiving a score <80 on
the Shipley verbal IQ Test
11. Non-English speaking; determined at phone screen
12. History of claustrophobia (contraindicated for MRI) or color blindness (task requires
color recognition); self-report at telephone screen
13. Being left-handed
14. Any fore-limb deformity
15. Wearing cochlear implant or bi-lateral hearing aids
General Exclusion
1. Any medical condition or concomitant medication that could compromise participant
safety or treatment, as determined by the Principal Investigator and/or Study
Physician.
2. Inability to provide informed consent or complete any of the study tasks as determined
by the Principal Investigator and/or Study Physician.
3. Any physical or visual impairment that may prevent the individual from using a
computer keyboard or completing any study tasks.
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Descriptive Information | ||||
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Brief Title ICMJE | Effects of Varenicline on Brain Activity During Nicotine Abstinence | |||
Official Title ICMJE | Neural Substrates of Varenicline's (Chantix®) Efficacy for Smoking Cessation | |||
Brief Summary | This project aims to define mechanisms through which varenicline might be an effective smoking cessation medication. | |||
Detailed Description | Thirty treatment seeking smokers will be recruited to complete a 40-day within-subject (cross-over), double-blind study that will assess effects of varenicline on brain activation while performing certain tasks. Prior to beginning the study, participants will complete an health and physical screening to determine final eligibility. Following a medication run-up and a 3.5 day abstinence period, participants will complete study period 1 (an fMRI scan while performing attention, working memory and emotion tasks). After a 14 to 21-day washout period the study procedures will be repeated with placebo (order of study medication counterbalanced). After completion of both study periods, all participants will be offered a 13-week quit smoking program with varenicline. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment | |||
Condition ICMJE | Nicotine Dependence | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Loughead J, Ray R, Wileyto EP, Ruparel K, Sanborn P, Siegel S, Gur RC, Lerman C. Effects of the alpha4beta2 partial agonist varenicline on brain activity and working memory in abstinent smokers. Biol Psychiatry. 2010 Apr 15;67(8):715-21. doi: 10.1016/j.biopsych.2010.01.016. Epub 2010 Mar 6. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 38 | |||
Original Estimated Enrollment ICMJE | 30 | |||
Actual Study Completion Date ICMJE | August 2008 | |||
Actual Primary Completion Date | August 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: Smoking Behavior
Alcohol/Drug Exclusion Criteria
Medication Exclusion Criteria
Medical Exclusion Criteria
General Exclusion
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00602927 | |||
Other Study ID Numbers ICMJE | 806623 GA30517A ( Other Identifier: Pfizer ) P50CA084718 ( U.S. NIH Grant/Contract ) | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Dr. Caryn Lerman, University of Pennsylvania | |||
Study Sponsor ICMJE | University of Pennsylvania | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | University of Pennsylvania | |||
Verification Date | May 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |