A Study To Evaluate The Efficacy And Safety Of Varenicline Compared To Placebo For Smoking Cessation Through Reduction

NCT01370356 | Completed Phase 4 Results DMC

• 2 other identifiers: A3051075REDUCE TO QUIT
• Study Type: interventional
• Target: 1,510
• Locations: 10 countries
• Sites: 65

Brief Summary

This study will determine whether varenicline is safe and helps people to quit smoking through reduction when they are not willing/able to make an abrupt quit attempt.

Conditions

Smoking Cessation

Keywords

smoking reduction; smoking cessation

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Carbon Monoxide (CO) Confirmed 10-Week Continuous Abstinence (CA) From Smoking

  Percentage of participants who remained abstinent from Week 15 to Week 24, inclusive, reporting no smoking and no use of nicotine-containing products since the last study visit or contact on the Nicotine Use Inventory (NUI) and confirmed by expired CO \< 10 ppm at any time point (CO measurements conducted at the clinic visits) during Weeks 15 through 24, inclusive. Missing CO was imputed as negative (CO ≤ 10 ppm).

  Week 15 - 24

Secondary Outcomes (4)

• Percentage of Participants With CO Confirmed 4-Week CA From Smoking

  Week 21 - 24

• Percentage of Participants With CO Confirmed Long Term CA From Smoking

  Weeks 21 - 52

• Percentage of Participants With 7-Day Point Prevalence of Smoking Cessation

  Week 12, 24, and 52

• Percentage of Participants With 4-Week Point Prevalence of Smoking Cessation

  Week 52

Study Arms (2)

Varenicline Tartrate

ACTIVE COMPARATOR

Drug: Varenicline Tartrate

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Varenicline Tartrate DRUG

Varenicline Tartrate oral tablets 2 (0.5mg) tablets twice a day for 24 weeks (first week titration)

Varenicline Tartrate

Placebo DRUG

Matching placebo 2 oral tablets twice a day for 24 weeks (first week titration)

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female cigarette smokers over the age of 18 years who are not willing/able to quit smoking within the next month but who are willing to attempt to reduce their smoking to work toward a quit attempt within the next 3 months.
• Subjects must have smoked an average of at least 10 cigarettes per day during the past year and during the month prior to the screening visit, with no continuous period of abstinence greater than 3 months in the past year and who have an exhaled carbon monoxide (CO) \>10 ppm at screening.
• Subjects with mild to moderate depression or anxiety may be included if their condition is stable.

You may not qualify if:

• Subjects with a history of a suicide attempt or any suicidal behavior in the past two years.
• Subjects with severe depression or anxiety.
• Subjects with psychosis, panic disorder, bipolar disorder, post traumatic stress disorder (PTSD), or schizophrenia.
• Subjects with alcohol or substance abuse or dependence (except nicotine) unless in full remission for at least 12 months.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (65)

Pharmacology Research Institute

Encino, California, 91316, United States

Location

Pharmacology Research Institute

Newport Beach, California, 92660, United States

Location

Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida, 32216, United States

Location

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, 32806, United States

Location

Central Kentucky Research Associates, Inc.

Lexington, Kentucky, 40509, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

The Center for Pharmaceutical Research, P.C.

Kansas City, Missouri, 64114, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198-5910, United States

Location

CRI Worldwide, LLC

Marlton, New Jersey, 08053, United States

Location

Clinical Research Integrity(CRI) Worldwide, LLC

Willingboro, New Jersey, 08046, United States

Location

Central New York Clinical Research

Manlius, New York, 13104, United States

Location

FutureSearch Clinical Trials, L.P.

Austin, Texas, 78731, United States

Location

Benchmark Research

Fort Worth, Texas, 76135, United States

Location

Healthfirst Medical Group

Fort Worth, Texas, 76135, United States

Location

Australian Clinical Research Network

Maroubra, New South Wales, 2035, Australia

Location

Brisbane South Clinical Research Centre

Carina Heights, Queensland, 4152, Australia

Location

Royal Brisbane and Women's Hospital

Herston, Queensland, 4029, Australia

Location

Emeritus Research

Malvern, Victoria, 3145, Australia

Location

Office of Dr. Ronald Collette

Burnaby, British Columbia, V5G 1T4, Canada

Location

James K. Lai, MD., Inc.

Vancouver, British Columbia, V5K 1K3, Canada

Location

White Hills Medical Clinic

St. John's, Newfoundland and Labrador, A1A 3R5, Canada

Location

Canadian Phase Onward Inc.

Toronto, Ontario, M3H 5S4, Canada

Location

Manna Research

Toronto, Ontario, M9W 4L6, Canada

Location

Clinique des Maladies Lipidiques de Quebec (CMLQ)

Québec, Quebec, G1V 4M6, Canada

Location

SurGal Clinic s.r.o.

Brno, 602 00, Czechia

Location

Fakultni nemocnice u sv. Anny v Brne

Brno, 656 91, Czechia

Location

Krajska nemocnice Liberec a.s., Plicni oddeleni

Liberec, 460 01, Czechia

Location

Mestska nemocnice Ostrava, Plicni oddeleni

Ostrava, 728 80, Czechia

Location

Vseobecna fakultni nemocnice v Praze, III. interni klinika

Prague, 120 00, Czechia

Location

Vseobecna fakultni nemocnice v Praze

Prague, 120 00, Czechia

Location

Ustredni vojenska nemocnice Praha

Prague, 169 02, Czechia

Location

Alexandria University

Alexandria, Egypt

Location

Ain Shams University Hospital

Cairo, Egypt

Location

El Fayoum university hospital

El Fayoum Qesm, Egypt

Location

Klinische Forschung Berlin

Berlin, 10787, Germany

Location

Klinische Forschung Berlin-Buch GmbH

Berlin, 13125, Germany

Location

Universitaetsklinikum Goettingen Zentrum Innere Medizin Abteilung Kardiologie und Pneumologie

Göttingen, 37075, Germany

Location

Universitaetsklinikum Goettingen, Zentrum Innere Medizin, Abteilung Kardiologie und Pneumologie

Göttingen, 37075, Germany

Location

Klinische Forschung Hamburg GmbH

Hamburg, 20253, Germany

Location

Medamed- Studienambulanz

Leipzig, 04109, Germany

Location

FOCUS Clinical Drug Development GmbH

Neuss, 41460, Germany

Location

Kubo Clinic

Yokohama, Kanagawa, Japan

Location

Nagatsuta family clinic

Yokohama, Kanagawa, Japan

Location

Sakakibara Clinic, Wakaumekai Medical Corporation

Yokohama, Kanagawa, Japan

Location

Saino Clinic

Tokorozawa, Saitama, Japan

Location

Tajima Clinic

Edogawa-ku, Tokyo, Japan

Location

Hachiouji Junkanki clinic

Hachiōji, Tokyo, Japan

Location

Arke Estudios Clinicos S.A.

México, D.f., 06700, Mexico

Location

Centro Respiratorio de Mexico S.C.

México, D.f., 14050, Mexico

Location

Clinica de Enfermedades Cronicas y de Procedimientos Especiales S.C.

Morelia, Michoacán, 58249, Mexico

Location

Centro de Estudios Clinicos y Especialidades Medicas SC

Monterrey, Nuevo León, 64620, Mexico

Location

Taichung Veterans General Hospital

Taichung, Taiwan, 40705, Taiwan

Location

Chang Gung Medical Foundation-Linkou Branch

Kweishan Town, Taoyuan County, 333, Taiwan

Location

Kaohsiung Veterans General Hosptial

Kaohsiung City, 813, Taiwan

Location

China Medical University Hospital

Taichung, 404, Taiwan

Location

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

National Taiwan University Hospital, Department of Family Medicine

Taipei, 100, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 112, Taiwan

Location

Enchord Limited

Fowey, Cornwall, PL23 1DT, United Kingdom

Location

The Alverton Practice

Penzance, Cornwall, TR18 4JH, United Kingdom

Location

Knowle House Surgery

Plymouth, Devon, PL5 3JB, United Kingdom

Location

Castlemilk Health Centre

Castlemilk, Glasgow, G45 9EW, United Kingdom

Location

Prince Philip Hospital

Dafen, Llanelli, SA14 8QF, United Kingdom

Location

Hathaway Medical Centre

Chippenham, Wilts, SN14 8GT, United Kingdom

Location

The Jenner Practice

London, SE23 1HU, United Kingdom

Location

Related Publications (4)

• Livingstone-Banks J, Fanshawe TR, Thomas KH, Theodoulou A, Hajizadeh A, Hartman L, Lindson N. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2023 May 5;5(5):CD006103. doi: 10.1002/14651858.CD006103.pub8.

  PMID: 37142273 DERIVED

• Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4.

  PMID: 34611902 DERIVED

• Nakamura M, Abe M, Ohkura M, Treadow J, Yu CR, Park PW. Efficacy of Varenicline for Cigarette Reduction Before Quitting in Japanese Smokers: A Subpopulation Analysis of the Reduce to Quit Trial. Clin Ther. 2017 Apr;39(4):863-872. doi: 10.1016/j.clinthera.2017.03.007. Epub 2017 Mar 30.

  PMID: 28365035 DERIVED

• Ebbert JO, Hughes JR, West RJ, Rennard SI, Russ C, McRae TD, Treadow J, Yu CR, Dutro MP, Park PW. Effect of varenicline on smoking cessation through smoking reduction: a randomized clinical trial. JAMA. 2015 Feb 17;313(7):687-94. doi: 10.1001/jama.2015.280.

  PMID: 25688780 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Smoking Cessation; Smoking Reduction

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Smoking

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

Two cases of fetal exposure during pregnancy occurred but are not included in the SAE section as they did not meet the criteria of serious in the safety database. One of them relates to a non-study participant who was the study participant's partner.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2011
• First Posted: June 9, 2011
• Study Start: July 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: September 1, 2014
• Results First Posted: September 1, 2014

Record last verified: 2014-08

Locations

CZ (7); TW (7); AU (4); JP (6); ME (4); DE (7); CA (6); GB (7); EG (3); US (14)