Combining Varenicline and Bupropion for Smoking Cessation

NCT00943618 | Completed Phase 3 Results DMC FDA Drug

• 3 other identifiers: 2008-0850R01DA024709-01A1NCI-2011-01101
• Study Type: interventional
• Target: 641
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is learn if the combination of Chantix (varenicline) and Zyban (bupropion) is more effective at helping people to quit smoking than varenicline when given alone. Researchers also want to learn if this drug combination can reduce cravings and other negative symptoms of nicotine withdrawal better than varenicline does alone. The safety of this drug combination will also be tested.

Conditions

Smoking Cessation

Keywords

Smoking Cessation; Nicotine Withdrawal; Smoking Reduction; Varenicline; Chantix; Bupropion; Zyban

Outcome Measures

Primary Outcomes (1)

• Smoking Abstinence at 12 Months

  Prolonged Abstinence is defined as no smoking from the quit date to 12 Months post quit date.

  From quit date to 12 months.

Study Arms (3)

Group 1

ACTIVE COMPARATOR

Varenicline and Bupropion

Drug: Varenicline; Drug: Bupropion; Behavioral: Counseling/Phone Calls

Group 2

PLACEBO COMPARATOR

Varenicline and Placebo

Drug: Varenicline; Other: Placebo; Behavioral: Counseling/Phone Calls

Group 3

PLACEBO COMPARATOR

Placebo that looks like varenicline and a placebo that looks like bupropion.

Other: Placebo; Behavioral: Counseling/Phone Calls

Interventions

Varenicline DRUG

On Days 1-3, .5mg tablet by mouth in the morning. Beginning on Day 4, and then every day after that, .5mg tablet by mouth in the morning and .5mg tablet by mouth in the evening (for a total of 2 doses).

Also known as: Chantix

Group 1; Group 2

Bupropion DRUG

On Days 1-3, 150 mg tablet by mouth in the morning. Beginning on Day 4, and then every day after that, 150 mg tablet by mouth in the morning and 150 mg tablet by mouth in the evening (for a total of 2 doses).

Also known as: Zyban

Group 1

Placebo OTHER

On Days 1-3, 1 tablet by mouth of placebo that looks like the study drug in the morning. Beginning on Day 4, and then every day after that, 1 tablet by mouth in the morning and 1 tablet by mouth in the evening for a total of 2 doses of the placebo each day.

Group 2; Group 3

Counseling/Phone Calls BEHAVIORAL

Brief-behavioral counseling sessions (10-15 minutes) provided to all participants once per week for 12 weeks. One support phone call conducted 3 days after the target quit date.

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 25-70 years old
• Smoking 5 or more cigarettes per day, on average, within the 2 months preceding the screening visit and expired CO of greater than or equal to 6ppm.
• Able to follow verbal and written instructions in English and complete all aspects of the study
• Provide informed consent and agree to all assessments and study procedures
• Have an address and home telephone number where they may be reached
• Be the only participant in their household

You may not qualify if:

• Within the month immediately preceding the screening visit, use of any form of tobacco products other than cigarettes on 3 or more days within a week if the individual refuses to refrain from such tobacco use during the course of the study.
• Within the month immediately preceding the screening visit, use of marijuana in any form on 3 or more days within a week
• Within the two weeks immediately preceding the screening visit, involvement on more than 3 days in any formal smoking cessation activities
• Treatment on a continuous basis within 2 weeks before the screening visit: any contraindicated medication for Varenicline or Bupropion. Classes of contraindicated medications include, but are not limited to, antiasthmatics, antipsychotics, some antidepressants, antihypertensives, antiarrhythmics, antineoplastics, some antiseizures, and MAO inhibitors (See Appendix U for specific list of excluded and precautionary medications).
• Uncontrolled hypertension (average reading of systolic blood pressure greater than 150 or diastolic blood pressure greater than 95) or other major contraindications for Bupropion or Varenicline (See section on Screening).
• Severe renal impairment (Creatinine Clearance less than 30 ml/min/1.73 m2).
• Laboratory evaluations outside normal limits and of potential clinical significance in the opinion of the investigator.
• Meet current criteria for psychiatric disorders or substance abuse as assessed by the MINI plus (major depressive episode) and the MINI for items B, D, I, J (Alcohol Addendum-past 6 months only), K, L, M and N including a past manic or hypomanic episode as well as a lifetime psychotic disorder.
• Individuals rated as moderate (6 - 9) to high (10 or greater) on suicidality as assessed by Module C of the MINI.
• Psychiatric hospitalization within 1 year of screening date.
• A positive urine pregnancy test during the screening period. Women who are two years post menopausal, or who have had a tubal ligation or a partial or full hysterectomy will not be subject to a urine pregnancy test.
• Pregnant, breast-feeding or of childbearing potential and is not protected by a medically acceptable, effective method of birth control while enrolled in the study. Medically acceptable contraceptives include: (1) approved hormonal contraceptives (such as birth control pills, patches, implants or injections), (2) barrier methods (such as a condom or diaphragm) used with a spermicide, or (3) an intrauterine device (IUD). Contraceptive measures sold for emergency use after unprotected sex, are not acceptable methods for routine use.
• Use of Varenicline or Bupropion within two weeks before the screening visit.
• History of hypersensitivity or allergic reaction to Varenicline, tricyclic antidepressant, Bupropion (Wellbutrin, Zyban) or similar chemical classes or any component of these formulations.
• Current or previous history of a seizure disorder.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Drug Abuse (NIDA): collaborator
• Pfizer: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (2)

• Cinciripini PM, Minnix JA, Green CE, Robinson JD, Engelmann JM, Versace F, Wetter DW, Shete S, Karam-Hage M. An RCT with the combination of varenicline and bupropion for smoking cessation: clinical implications for front line use. Addiction. 2018 Apr 21:10.1111/add.14250. doi: 10.1111/add.14250. Online ahead of print.

  PMID: 29679432 RESULT

• 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

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Smoking Cessation; Smoking Reduction

Interventions

Varenicline; Bupropion; Counseling

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Smoking

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines; Propiophenones; Ketones; Organic Chemicals; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Paul M. Cinciripini, BS,MS,PHD/Chair, Behavioral Science
• Organization: UT MD Anderson Cancer Center

pcinciri@mdanderson.org

(713) 745-1868

Study Officials

• Paul M Cinciripini, PhD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2009
• First Posted: July 22, 2009
• Study Start: May 17, 2010
• Primary Completion: May 31, 2020
• Study Completion: September 9, 2021
• Last Updated: May 4, 2025
• Results First Posted: July 8, 2021

Record last verified: 2025-04

Locations

US (1)