Human Laboratory Study Of Varenicline in Smokers

NCT ID: NCT00709696

Last Updated: 2017-12-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2009-12-31

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.

Conditions

Nicotine Dependence

Keywords

Tobacco; nicotine; smoking; varenicline; human laboratory study; stress tolerance; startle response; cognitive assessment; progressive ratio

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

1

Placebo Varenicline

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.).

2

Varenicline

Group Type: ACTIVE_COMPARATOR

Varenicline

Intervention Type: DRUG

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.).

Interventions

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.).

Intervention Type: 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.).

Intervention Type: DRUG

Other Intervention Names

Chantix; Chantix

Eligibility 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. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Pfizer

INDUSTRY

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marc E Mooney, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Andrew Oliver, B.A.

Role: STUDY_DIRECTOR

University of Minnesota

Locations

Tobacco Use Research Center

Minneapolis, Minnesota, United States

Countries

United States

References

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Reference Type: BACKGROUND

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Other Identifiers

K01DA019446

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DPMCDA

Identifier Type: OTHER

Identifier Source: secondary_id

0702M02324

Identifier Type: -

Identifier Source: org_study_id