Human Laboratory Study Of Varenicline in Smokers

NCT00709696

Last updated date
Study Location
Tobacco Use Research Center
Minneapolis, Minnesota, 55414, 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
18-60 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1.1. Who. Subjects will be women and men between the ages of 18 and 40 who have smoked at least 10 cigarettes per day for at least 1 year. They will respond to requests in the public media for individuals who are interested in quitting smoking.

1.2. Total sample/Number per group. The total randomized sample size will equal 20 subjects, equally distributed across the two medication groups.

1.3. Inclusion Criteria.

1. 18 years to 60 years.

2. Smoke Marlboro Lights (This criterion was selected to reduce inter-subject variation in response variables as has been done in many human laboratory studies of smoking behavior. Over 40% of all smokers smoke some type of the Marlboro brand of cigarette (Substance Abuse and Mental Health Services Administration, 2005). Based on telephone screen data for 767 subjects collected at TURC, Marlboro Light cigarettes are the most common type of Marlboro smoked in our sampling population (158/252 Marlboro users [63%]). Therefore, we have decided to only enroll those smoking Marlboro Light cigarettes, non-menthol).

3. Smoked at least 10 cigarettes/day for at least 1 year.

4. English speaking and reading.

5. Females who are of childbearing potential must practice effective contraception and meet the following criteria:

1. Are instructed to avoid pregnancy through 30 days after the last dose of study medication.

2. Have a negative urine pregnancy test at baseline.

3. Agree to use of the birth control methods listed: an oral contraceptive agent, an intrauterine device (IUD), an implantable contraceptive (e.g., Norplant), or an injectable contraceptive (e.g., Depo-Provera) for at least one month prior to entering the study and will continue its use through at least 30 days after the last dose of the study medication. A barrier method of contraception (e.g., condom or diaphragm with spermicide) while participating in the study and 30 days after the last dose of study medication.

6. Willingness to not use illicit drugs during study period including marijuana.

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


1. Concurrent use of tobacco products (other than cigarettes) or nicotine products.


2. Medications that might affect the outcome measures of nicotine reward, cognition,
anxiety, and stress will also be a basis for exclusion. These medications include
psychotropic drugs (i.e., anti-psychotic, anti-depressant, anti-anxiety, or
stimulant), anti- hypertensive agents (e.g., beta-blockers), and other drugs that can
influence the outcome domains.


3. History of kidney disease or renal impairment since varenicline is primarily excreted
by the kidney and thus such patients are vulnerable to increased and potentially toxic
levels of varenicline.


4. Treatment for drug or alcohol dependence during the last year, or evidence of alcohol
abuse so severe that the patient is judged potentially unable to comply with the
protocol.


5. Suicidal or homicidal ideation.


6. History of bipolar disorder, schizophrenia, schizoaffective disorder, attention
deficit disorder, or attention deficit hyperactivity disorder.


7. Current major depression or anxiety disorder.


8. Pregnant or lactating or planning pregnancy during treatment period.


9. Having plans to leave the immediate geographical area within 2 months.


10. Unwillingness or inability to give written informed consent.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Human Laboratory Study Of Varenicline in Smokers
Official Title  ICMJE Human Laboratory Study Of Varenicline in Smokers
Brief Summary The purpose of this study is to test the ways that a drug called varenicline helps smokers to quit smoking. Varenicline is also called Chantix® and is approved by the United States Food and Drug Administration (FDA) to help people quit smoking. We will test how varenicline works by having you quit smoking and complete tasks that assess how you think and feel. We predict that varenicline help reduce anxiety, improve attention and concentration, and reduce how satisfying cigarettes are.
Detailed Description The purpose of this study is to understand the therapeutic mechanisms of varenicline, a novel nicotinic analogue, through focused measures of potential psychological and physiological mediators. Varenicline is an FDA-approved pharmacotherapy for smoking cessation that is believed to provide relief from craving and withdrawal through agonism and antagonism of some central nervous system nicotinic acetylcholinergic receptors. However, no controlled studies have established the physiological and psychological processes that mediate the efficacy of varenicline in humans. The main goal of the proposed pilot study is to evaluate and compare the effects of varenicline on subjective, cognitive, and physiological outcomes, using a randomized, placebo-controlled, double-blind between-groups design. The study will combine both brief clinical trial methodology with human laboratory approaches. A secondary goal is to validate the utility of the laboratory paradigms for the identification of future smoking cessation agents.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Condition  ICMJE Nicotine Dependence
Intervention  ICMJE
  • Drug: Placebo
    Days 1 - 3 (0.5 mg tablet, q.d.), Days 4 - 7 (0.5 mg tablet, b.i.d.), and Day 8 - 21 (1 mg tablet, b.i.d.).
    Other Name: Chantix
  • Drug: Varenicline
    Days 1 - 3 (0.5 mg tablet, q.d.), Days 4 - 7 (0.5 mg tablet, b.i.d.), and Day 8 - 21 (1 mg tablet, b.i.d.).
    Other Name: Chantix
Study Arms  ICMJE
  • Placebo Comparator: 1
    Placebo Varenicline
    Intervention: Drug: Placebo
  • Active Comparator: 2
    Varenicline
    Intervention: Drug: Varenicline
Publications *

*   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: December 1, 2017)
7
Original Estimated Enrollment  ICMJE
 (submitted: July 2, 2008)
20
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

1.1. Who. Subjects will be women and men between the ages of 18 and 40 who have smoked at least 10 cigarettes per day for at least 1 year. They will respond to requests in the public media for individuals who are interested in quitting smoking.

1.2. Total sample/Number per group. The total randomized sample size will equal 20 subjects, equally distributed across the two medication groups.

1.3. Inclusion Criteria.

  1. 18 years to 60 years.
  2. Smoke Marlboro Lights (This criterion was selected to reduce inter-subject variation in response variables as has been done in many human laboratory studies of smoking behavior. Over 40% of all smokers smoke some type of the Marlboro brand of cigarette (Substance Abuse and Mental Health Services Administration, 2005). Based on telephone screen data for 767 subjects collected at TURC, Marlboro Light cigarettes are the most common type of Marlboro smoked in our sampling population (158/252 Marlboro users [63%]). Therefore, we have decided to only enroll those smoking Marlboro Light cigarettes, non-menthol).
  3. Smoked at least 10 cigarettes/day for at least 1 year.
  4. English speaking and reading.
  5. Females who are of childbearing potential must practice effective contraception and meet the following criteria:

    1. Are instructed to avoid pregnancy through 30 days after the last dose of study medication.
    2. Have a negative urine pregnancy test at baseline.
    3. Agree to use of the birth control methods listed: an oral contraceptive agent, an intrauterine device (IUD), an implantable contraceptive (e.g., Norplant), or an injectable contraceptive (e.g., Depo-Provera) for at least one month prior to entering the study and will continue its use through at least 30 days after the last dose of the study medication. A barrier method of contraception (e.g., condom or diaphragm with spermicide) while participating in the study and 30 days after the last dose of study medication.
  6. Willingness to not use illicit drugs during study period including marijuana.

Exclusion Criteria:

  1. Concurrent use of tobacco products (other than cigarettes) or nicotine products.
  2. Medications that might affect the outcome measures of nicotine reward, cognition, anxiety, and stress will also be a basis for exclusion. These medications include psychotropic drugs (i.e., anti-psychotic, anti-depressant, anti-anxiety, or stimulant), anti- hypertensive agents (e.g., beta-blockers), and other drugs that can influence the outcome domains.
  3. History of kidney disease or renal impairment since varenicline is primarily excreted by the kidney and thus such patients are vulnerable to increased and potentially toxic levels of varenicline.
  4. Treatment for drug or alcohol dependence during the last year, or evidence of alcohol abuse so severe that the patient is judged potentially unable to comply with the protocol.
  5. Suicidal or homicidal ideation.
  6. History of bipolar disorder, schizophrenia, schizoaffective disorder, attention deficit disorder, or attention deficit hyperactivity disorder.
  7. Current major depression or anxiety disorder.
  8. Pregnant or lactating or planning pregnancy during treatment period.
  9. Having plans to leave the immediate geographical area within 2 months.
  10. Unwillingness or inability to give written informed consent.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 60 Years   (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 NCT00709696
Other Study ID Numbers  ICMJE 0702M02324
K01DA019446 ( U.S. NIH Grant/Contract )
DPMCDA ( Other Identifier: NIDA )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Minnesota
Study Sponsor  ICMJE University of Minnesota
Collaborators  ICMJE
  • National Institute on Drug Abuse (NIDA)
  • Pfizer
Investigators  ICMJE
Principal Investigator:Marc E Mooney, Ph.D.University of Minnesota
Study Director:Andrew Oliver, B.A.University of Minnesota
PRS Account University of Minnesota
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP