Human Laboratory Study Of Varenicline in Smokers

December 1, 2017 updated by: University of Minnesota
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55414
        • Tobacco Use Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Chantix

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Collaborators

National Institute on Drug Abuse (NIDA)
Pfizer

Investigators

  • Study Director: Andrew Oliver, B.A., University of Minnesota

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (ACTUAL)

December 1, 2009

Study Completion (ACTUAL)

December 1, 2009

Study Registration Dates

First Submitted

July 1, 2008

First Submitted That Met QC Criteria

July 2, 2008

First Posted (ESTIMATE)

July 3, 2008

Study Record Updates

Last Update Posted (ACTUAL)

December 27, 2017

Last Update Submitted That Met QC Criteria

December 1, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0702M02324
  • DPMCDA (Other Identifier: NIDA)
  • K01DA019446 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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