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Human Laboratory Study Of Varenicline in Smokers

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ClinicalTrials.gov Identifier: NCT00709696
Recruitment Status : Completed
First Posted : July 3, 2008
Results First Posted : December 27, 2017
Last Update Posted : December 27, 2017
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
Pfizer
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

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.

Condition or disease Intervention/treatment Phase
Nicotine Dependence Drug: Placebo Drug: Varenicline Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Human Laboratory Study Of Varenicline in Smokers
Study Start Date : April 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: 1
Placebo Varenicline
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
Active Comparator: 2
Varenicline
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



Primary Outcome Measures :
  1. Nicotine Withdrawal Scale [ Time Frame: 21 days ]
    Scale is equal to days subject did not smoke Scale is 0-5 0 being no days 5 being did not quit at all



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00709696


Locations
United States, Minnesota
Tobacco Use Research Center
Minneapolis, Minnesota, United States, 55414
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
National Institute on Drug Abuse (NIDA)
Pfizer
Investigators
Principal Investigator: Marc E Mooney, Ph.D. University of Minnesota - Clinical and Translational Science Institute
Study Director: Andrew Oliver, B.A. University of Minnesota - Clinical and Translational Science Institute

Publications:

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00709696     History of Changes
Other Study ID Numbers: 0702M02324
K01DA019446 ( U.S. NIH Grant/Contract )
DPMCDA ( Other Identifier: NIDA )
First Posted: July 3, 2008    Key Record Dates
Results First Posted: December 27, 2017
Last Update Posted: December 27, 2017
Last Verified: December 2017

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Tobacco
nicotine
smoking
varenicline
human laboratory study
stress tolerance
startle response
cognitive assessment
progressive ratio

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Varenicline
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs