Human Laboratory Study Of Varenicline in Smokers

NCT00709696 | Completed Results

• 3 other identifiers: 0702M02324K01DA019446DPMCDA
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Nicotine Dependence

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Nicotine Withdrawal Scale

  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

Study Arms (2)

1

PLACEBO COMPARATOR

Placebo Varenicline

Drug: Placebo

2

ACTIVE COMPARATOR

Varenicline

Drug: Varenicline

Interventions

Placebo 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.).

Also known as: Chantix

1

Varenicline 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.).

Also known as: Chantix

2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Total sample/Number per group. The total randomized sample size will equal 20 subjects, equally distributed across the two medication groups.
• years to 60 years.
• 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).
• Smoked at least 10 cigarettes/day for at least 1 year.
• English speaking and reading.
• Females who are of childbearing potential must practice effective contraception and meet the following criteria:
• Are instructed to avoid pregnancy through 30 days after the last dose of study medication.
• Have a negative urine pregnancy test at baseline.
• 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.
• Willingness to not use illicit drugs during study period including marijuana.

You may not qualify if:

• Concurrent use of tobacco products (other than cigarettes) or nicotine products.
• 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.
• 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.
• Suicidal or homicidal ideation.
• History of bipolar disorder, schizophrenia, schizoaffective disorder, attention deficit disorder, or attention deficit hyperactivity disorder.
• Current major depression or anxiety disorder.
• Pregnant or lactating or planning pregnancy during treatment period.
• Having plans to leave the immediate geographical area within 2 months.
• Unwillingness or inability to give written informed consent.

Sponsors & Collaborators

• University of Minnesota: lead
• National Institute on Drug Abuse (NIDA): collaborator
• Pfizer: collaborator

Study Sites (1)

Tobacco Use Research Center

Minneapolis, Minnesota, 55414, United States

Location

Related Publications (12)

• Tonstad S, Tonnesen P, Hajek P, Williams KE, Billing CB, Reeves KR; Varenicline Phase 3 Study Group. Effect of maintenance therapy with varenicline on smoking cessation: a randomized controlled trial. JAMA. 2006 Jul 5;296(1):64-71. doi: 10.1001/jama.296.1.64.

  PMID: 16820548 BACKGROUND

• Oncken C, Gonzales D, Nides M, Rennard S, Watsky E, Billing CB, Anziano R, Reeves K. Efficacy and safety of the novel selective nicotinic acetylcholine receptor partial agonist, varenicline, for smoking cessation. Arch Intern Med. 2006 Aug 14-28;166(15):1571-7. doi: 10.1001/archinte.166.15.1571.

  PMID: 16908789 BACKGROUND

• Nides M, Oncken C, Gonzales D, Rennard S, Watsky EJ, Anziano R, Reeves KR. Smoking cessation with varenicline, a selective alpha4beta2 nicotinic receptor partial agonist: results from a 7-week, randomized, placebo- and bupropion-controlled trial with 1-year follow-up. Arch Intern Med. 2006 Aug 14-28;166(15):1561-8. doi: 10.1001/archinte.166.15.1561.

  PMID: 16908788 BACKGROUND

• Jorenby DE, Hays JT, Rigotti NA, Azoulay S, Watsky EJ, Williams KE, Billing CB, Gong J, Reeves KR; Varenicline Phase 3 Study Group. Efficacy of varenicline, an alpha4beta2 nicotinic acetylcholine receptor partial agonist, vs placebo or sustained-release bupropion for smoking cessation: a randomized controlled trial. JAMA. 2006 Jul 5;296(1):56-63. doi: 10.1001/jama.296.1.56.

  PMID: 16820547 BACKGROUND

• Gonzales D, Rennard SI, Nides M, Oncken C, Azoulay S, Billing CB, Watsky EJ, Gong J, Williams KE, Reeves KR; Varenicline Phase 3 Study Group. Varenicline, an alpha4beta2 nicotinic acetylcholine receptor partial agonist, vs sustained-release bupropion and placebo for smoking cessation: a randomized controlled trial. JAMA. 2006 Jul 5;296(1):47-55. doi: 10.1001/jama.296.1.47.

  PMID: 16820546 BACKGROUND

• Nakamura M, Oshima A, Fujimoto Y, Maruyama N, Ishibashi T, Reeves KR. Efficacy and tolerability of varenicline, an alpha4beta2 nicotinic acetylcholine receptor partial agonist, in a 12-week, randomized, placebo-controlled, dose-response study with 40-week follow-up for smoking cessation in Japanese smokers. Clin Ther. 2007 Jun;29(6):1040-56. doi: 10.1016/j.clinthera.2007.06.012.

  PMID: 17692720 BACKGROUND

• Tsai ST, Cho HJ, Cheng HS, Kim CH, Hsueh KC, Billing CB Jr, Williams KE. A randomized, placebo-controlled trial of varenicline, a selective alpha4beta2 nicotinic acetylcholine receptor partial agonist, as a new therapy for smoking cessation in Asian smokers. Clin Ther. 2007 Jun;29(6):1027-39. doi: 10.1016/j.clinthera.2007.06.011.

  PMID: 17692719 BACKGROUND

• Williams KE, Reeves KR, Billing CB Jr, Pennington AM, Gong J. A double-blind study evaluating the long-term safety of varenicline for smoking cessation. Curr Med Res Opin. 2007 Apr;23(4):793-801. doi: 10.1185/030079907x182185.

  PMID: 17407636 BACKGROUND

• Aubin HJ, Bobak A, Britton JR, Oncken C, Billing CB Jr, Gong J, Williams KE, Reeves KR. Varenicline versus transdermal nicotine patch for smoking cessation: results from a randomised open-label trial. Thorax. 2008 Aug;63(8):717-24. doi: 10.1136/thx.2007.090647. Epub 2008 Feb 8.

  PMID: 18263663 BACKGROUND

• Niaura R, Hays JT, Jorenby DE, Leone FT, Pappas JE, Reeves KR, Williams KE, Billing CB Jr. The efficacy and safety of varenicline for smoking cessation using a flexible dosing strategy in adult smokers: a randomized controlled trial. Curr Med Res Opin. 2008 Jul;24(7):1931-41. doi: 10.1185/03007990802177523. Epub 2008 May 29.

  PMID: 18513462 BACKGROUND

• Nides M, Glover ED, Reus VI, Christen AG, Make BJ, Billing CB Jr, Williams KE. Varenicline versus bupropion SR or placebo for smoking cessation: a pooled analysis. Am J Health Behav. 2008 Nov-Dec;32(6):664-75. doi: 10.5555/ajhb.2008.32.6.664.

  PMID: 18442345 BACKGROUND

• Stapleton JA, Watson L, Spirling LI, Smith R, Milbrandt A, Ratcliffe M, Sutherland G. Varenicline in the routine treatment of tobacco dependence: a pre-post comparison with nicotine replacement therapy and an evaluation in those with mental illness. Addiction. 2008 Jan;103(1):146-54. doi: 10.1111/j.1360-0443.2007.02083.x. Epub 2007 Nov 19.

  PMID: 18028247 BACKGROUND

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Results Point of Contact

• Title: Dr. Marc Mooney
• Organization: University of Minnesota

moon0078@umn.edu

612-991-6875

Study Officials

• Marc E Mooney, Ph.D.

  University of Minnesota

  PRINCIPAL INVESTIGATOR

• Andrew Oliver, B.A.

  University of Minnesota

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2008
• First Posted: July 3, 2008
• Study Start: April 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: December 27, 2017
• Results First Posted: December 27, 2017

Record last verified: 2017-12

Locations

US (1)