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Effects of Varenicline on Brain Activity During Nicotine Abstinence
This study is currently recruiting participants.
Verified by University of Pennsylvania, January 2008
Sponsored by: University of Pennsylvania
Information provided by: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00602927
  Purpose

This project aims to define mechanisms through which varenicline might be an effective smoking cessation medication.


Condition Intervention
Nicotine Dependence
Drug: Varenicline
Drug: Placebo

MedlinePlus related topics: Quitting Smoking Smoking
Drug Information available for: Varenicline Nicotine polacrilex Nicotine tartrate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Crossover Assignment, Efficacy Study
Official Title: Neural Substrates of Varenicline's (Chantix®) Efficacy for Smoking Cessation

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Brain activation levels when performing tasks while on placebo vs. Varenicline [ Time Frame: Aug. 2008 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlation between brain activation levels during the MRI and quit rates from the clinical phase. [ Time Frame: Sept 2008 ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: November 2007
Estimated Study Completion Date: August 2008
Estimated Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Placebo Comparator Drug: Placebo
2mg/day
2: Active Comparator Drug: Varenicline
Varenicline 2mg/day

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  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 reading of >10ppm
  3. Provide written informed consent and are fluent, English-speaking
  4. Weight of equal to or less than 300 lbs

Exclusion Criteria:

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 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 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, 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 CNS) tumor
  9. Use of pacemakers, certain metallic implants, or presence of metal in the eye as contraindicated for MRI;
  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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00602927

Contacts
Contact: Riju Ray, MBBS, PhD 215-746-7152 rijuray@mail.med.upenn.edu
Contact: Angela Pinto, MBA 215-746-7171 pintoa@mail.med.upenn.edu

Locations
United States, Pennsylvania
Tobbaco Use Research Center Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Riju Ray, MBBS, PhD     215-746-7152     rijuray@mail.med.upenn.edu    
Contact: Angela Pinto, MBA     215-746-7171     pintoa@mail.med.upenn.edu    
Principal Investigator: Caryn Lerman, PhD            
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Caryn Lerman, PhD University of Pennsylvania
  More Information

Responsible Party: University of Pennsylvania ( Dr. Caryn Lerman )
Study ID Numbers: 806623, GA30517A, TTURC P50 84718
Study First Received: January 15, 2008
Last Updated: January 26, 2008
ClinicalTrials.gov Identifier: NCT00602927  
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Nicotine polacrilex
Smoking
Nicotine
Mental Disorders
Tobacco Use Disorder
Substance-Related Disorders
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on January 14, 2009