Effects of Varenicline on Brain Activity During Nicotine Abstinence

NCT00602927

Last updated date
Study Location
Tobacco Use Research Center
Philadelphia, Pennsylvania, 19104, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Nicotine Dependence
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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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Advanced Information
Descriptive Information
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
  • Drug: Varenicline
    Day 1 - Day 3 0.5mg once daily Day 4 - Day 7 0.5mg twice daily Day 8 - Day 13 1.0mg twice daily
    Other Name: Chantix
  • Drug: Placebo
    Participants will take placebo pills for 13 days using the same regimen as the varenicline study period.
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Active Comparator: Varenicline
    Intervention: Drug: Varenicline
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
 (submitted: April 1, 2011)
38
Original Estimated Enrollment  ICMJE
 (submitted: January 26, 2008)
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:

  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

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 (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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
  • Pfizer
  • National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator:Caryn Lerman, PhDUniversity of Pennsylvania
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