Phase 3 Completed N=506 Randomized Quadruple-blind Treatment

Varenicline and Bupropion for Smoking Cessation

Smoking

Source: ClinicalTrials.gov NCT00935818 ↗

Enrolled (actual)

506

Serious AEs

2.4%

Results posted

Apr 2014

Primary outcomePrimary: Prolonged Smoking Abstinence Rates at 12 Weeks in Cigarettes Smokers. — 132; 111 participants — p=0.03

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Prolonged Smoking Abstinence Rates at 12 Weeks in Cigarettes Smokers.	132; 111	0.03 sig
PRIMARY Point Prevalence Abstinence at 3 Months.	140; 125	0.09
SECONDARY Prolonged Smoking Abstinence Rates at 26 Weeks in Cigarettes Smokers.	91; 71	0.03 sig
SECONDARY Weight Gain From Baseline to 3 Months	1.1; 2.5	< 0.001 sig
SECONDARY Point Prevalence Abstinence at 6 Months.	95; 82	0.14
SECONDARY Prolonged Abstinence at 12 Months	77; 63	0.11
SECONDARY Point Prevalence Abstinence at 12 Months	91; 75	0.08

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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);
untreated hypertension or baseline systolic blood pressure > 180 or diastolic > 100;
current treatment with another investigational drug for tobacco dependence (previous 30 days); or
current use of bupropion or varenicline (previous 30 days).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00935818). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.