Varenicline and Bupropion for Smoking Cessation

NCT00935818 | Completed Phase 2 Results DMC

• 3 other identifiers: 09-00359809-0024591R01CA138417
• Study Type: interventional
• Target: 506
• Locations: 1 country
• Sites: 3

Brief Summary

This study provides an opportunity to combine varenicline and bupropion SR and capitalize on the potential additive benefit. The investigators hypothesize that this will further increase long-term (≥ 6 months) smoking abstinence rates.

Conditions

Smoking

Keywords

smoking; nicotine; tobacco; dependence; cessation; abstinence

Outcome Measures

Primary Outcomes (2)

• Prolonged Smoking Abstinence Rates at 12 Weeks in Cigarettes Smokers.

  Prolonged smoking abstinence is defined as no smoking, not even a puff, in the last 7 days, and a negative response to the question "Since 2 weeks after your target quit date, have you smoked any tobacco, even a puff, for 7 consecutive days or at least once each week on 2 consecutive weeks?"

  3 months

• Point Prevalence Abstinence at 3 Months.

  biochemically confirmed 7-day point prevalence abstinence defined as no smoking, not even a puff, in the previous 7 days.

  3 months

Secondary Outcomes (5)

• Prolonged Smoking Abstinence Rates at 26 Weeks in Cigarettes Smokers.

  6 months

• Weight Gain From Baseline to 3 Months

  3 months

• Point Prevalence Abstinence at 6 Months.

  6 months

• Prolonged Abstinence at 12 Months

  12 months

• Point Prevalence Abstinence at 12 Months

  12 months

Study Arms (2)

varenicline and buproprion SR

ACTIVE COMPARATOR

Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.

Drug: Varenicline; Drug: bupropion SR

varenicline and placebo

PLACEBO COMPARATOR

Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.

Drug: Varenicline; Drug: placebo

Interventions

Varenicline DRUG

varenicline - 1 mg bid for 12 weeks

Also known as: chantix

varenicline and buproprion SR; varenicline and placebo

placebo DRUG

placebo for 12 weeks

Also known as: sugar pill

varenicline and placebo

bupropion SR DRUG

bupropion sr - 150 mg bid for 12 weeks

Also known as: wellbutrin SR, zyban

varenicline and buproprion SR

Eligibility Criteria

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

You may qualify if:

• Subject is at least 18 years of age;
• Subject has provide written informed consent;
• Subject is smoking greater than or equal to 10 cigarettes per day for at least 6 months;
• \) Subject is able to complete all study visits 4) Subject is in good health as determined by the investigator 5) Subject has the ability to participate fully in all aspects of the study and keep scheduled appointments 6) Subject is motivated to stop smoking.

You may not qualify if:

• Female and were pregnant, lactating or likely to become pregnant during the trial and not able nor willing to use contraception or had:
• an unstable medical condition;
• another household member participating in the study;
• bupropion or varenicline allergy;
• current use (previous 30 days) of a tobacco dependence treatment and unable or unwilling to discontinue use;
• an unstable medical condition or unstable angina, myocardial infarction, or coronary angioplasty (past 3 months) or an untreated cardiac dysrhythmia;
• a history of renal failure or were on renal dialysis;
• a history of seizures;
• as defined by the C-SSRS (Columbia-Suicide Severity Rating Scale), current non-specific suicidal thoughts or lifetime history of a suicidal attempt (defined as "potentially self-injurious act committed with at least some wish to die, as a result of act");
• a history of closed head trauma associated with \> 30 minutes of loss of consciousness, amnesia, skull fracture, subdural hematoma, or brain contusion;
• a history or psychosis, bipolar disorder, bulimia or anorexia nervosa;
• current moderate or severe depression as assessed by a score of ≥ 20 on the Beck Depression Inventory, Second Edition (BDI-II) 10;
• active substance abuse other than nicotine;
• current (past 14 days) use of an antipsychotic, monoamine oxidase inhibitors, or drugs known to interact with bupropion SR;
• a recent dose change of their antidepressant (within last 3 months);

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator
• University of Minnesota: collaborator

Study Sites (3)

University Of Minnesota

Minneapolis, Minnesota, 55414, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Franciscan Skemp Hospital

La Crosse, Wisconsin, 54601, United States

Location

Related Publications (3)

• Ebbert JO, Hatsukami DK, Croghan IT, Schroeder DR, Allen SS, Hays JT, Hurt RD. Combination varenicline and bupropion SR for tobacco-dependence treatment in cigarette smokers: a randomized trial. JAMA. 2014 Jan 8;311(2):155-63. doi: 10.1001/jama.2013.283185.

  PMID: 24399554 RESULT

• 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

MeSH Terms

Conditions

Smoking

Interventions

Varenicline; Sugars; Bupropion

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines; Carbohydrates; Propiophenones; Ketones; Organic Chemicals

Results Point of Contact

• Title: Dr. Jon Ebbert
• Organization: Mayo Clinic

ebbert.jon@mayo.edu

507-284-4736

Study Officials

• Jon Ebbet, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Dorothy Hatsukami, PhD

  University of Minnesota

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 6, 2009
• First Posted: July 9, 2009
• Study Start: September 1, 2009
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: May 9, 2014
• Results First Posted: April 24, 2014

Record last verified: 2014-04

Locations

US (3)