A Study of Varenicline and Bupropion Combined to Stop Smoking

Overview

About this study

The purpose of this study is to assess the effects of combining varenicline and bupropion SR for a potential additive benefit for helping patients stop smoking for longer periods (≥ 6 months smoking abstinence rates).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Age at least 18 years
  • Has provided written informed consent
  • Has smoked greater than or equal to 10 cigarettes per day for at least 6 months
  • Able to complete all study visits
  • In good health as determined by the investigator
  • Has ability to participate fully in all aspects of the study and keep scheduled appointments
  • Is motivated to stop smoking

Exclusion Criteria

  • Pregnant, lactating or likely to become pregnant during the trial and not able or willing to use contraception
  • 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 was on renal dialysis
  • 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"
  • History of closed head trauma associated with > 30 minutes of loss of consciousness, amnesia, skull fracture, subdural hematoma, or brain contusion
  • History of 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;
  • Recent dose change of antidepressant (within last 3 months)
  • Untreated hypertension or baseline systolic blood pressure > 180 or diastolic > 100
  • Current treatment with another investigational drug for tobacco dependence (previous 30 days)
  • Current use of bupropion or varenicline (previous 30 days)

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Jon Ebbert, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20315391

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