Smoking, Tobacco Use Disorder
Conditions
Keywords
Smoking, Smoking cessation, Bupropion, Varenicline, Tobacco use disorder
Brief summary
The overarching goal of this line of research is to increase smoking abstinence rates using a combination of existing pharmacotherapies. The aim of the current study is to assess the safety and compliance as well as obtain preliminary estimates of efficacy and effect on craving and nicotine withdrawal of combination therapy with bupropion SR and varenicline. We will compare the efficacy estimates in this study with historical smoking abstinence rates with varenicline. To accomplish our aims, we will enroll 38 cigarette smokers in an open-label, phase II clinical trial.
Detailed description
Subjects will be eligible to participate if they: 1) are at least 18 years of age; 2) have smoked 10 or more cigarettes per day for at least 6 months; and 3) are motivated to stop smoking. Subjects will be excluded if they have: 1) an unstable medical condition; 2) unstable angina, myocardial infarction, or coronary angioplasty within the past 3 months or an untreated cardiac dysrhythmia; 3) personal history of seizures; 4) closed head trauma with any loss of consciousness or amnesia in the last 5 years; 5) ever history of closed head trauma with \> 30 minutes of loss of consciousness or amnesia or resulting in skull fracture or subdural hematoma/brain contusion; 6) a history or psychosis, bipolar disorder, bulimia or anorexia nervosa); 7) have current depression as assessed by Center for Epidemiologic Studies Depression (CES-D); 8) have active substance abuse other than nicotine; 9) have used an investigational drug within the last 30 days; 10) are currently using a behavioral or pharmacologic tobacco treatment and unwilling or unable to discontinue use; 11) use of bupropion or varenicline in the previous 3 months; 12) current (past 14 days) use of antipsychotic or antidepressant; 13) an allergy to bupropion or varenicline; 14) untreated hypertension or baseline systolic blood pressure \> 180 or diastolic \> 100; 15) have another member of their household already participating in this study. The primary aims and hypotheses of this study are: 1. To obtain preliminary evidence of efficacy of 12 weeks of combination therapy with bupropion SR and varenicline for increasing the point prevalence smoking abstinence rates at 12 weeks among cigarette smokers. Hypothesis: The combination of bupropion SR plus varenicline for 12 weeks will increase the point prevalence smoking abstinence rates at 12 weeks among cigarettes smokers. 2. To obtain preliminary evidence of efficacy of combination therapy with bupropion SR and varenicline for decreasing craving and nicotine withdrawal symptoms among cigarette smokers trying to achieve smoking abstinence. Hypothesis: 12 weeks of combination therapy with bupropion SR and varenicline will significantly decrease craving and nicotine withdrawal among cigarette smokers trying to achieve smoking abstinence.
Interventions
DRUGBupropion SR & Varenicline
Bupropion SR 150 mg by mouth once day for 3 days then 150 mg by mouth twice per day. Varenicline 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4 to 7, and then to the maintenance dose of 1 mg twice daily for the 12 weeks of treatment.
Sponsors
Mayo Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* at least 18 years of age * have smoked 10 or more cigarettes per day for at least 6 months * are motivated to stop smoking.
Exclusion criteria
* an unstable medical condition * unstable angina, myocardial infarction, or coronary angioplasty within the past 3 months or an untreated cardiac dysrhythmia * personal history of seizures * closed head trauma with any loss of consciousness or amnesia in the last 5 years * ever history of closed head trauma with \> 30 minutes of loss of consciousness or amnesia or resulting in skull fracture or subdural hematoma/brain contusion * a history or psychosis, bipolar disorder, bulimia or anorexia nervosa) * have current depression as assessed by Center for Epidemiologic Studies Depression (CES-D) * have active substance abuse other than nicotine * have used an investigational drug within the last 30 days * are currently using a behavioral or pharmacologic tobacco treatment and unwilling or unable to discontinue use * use of bupropion or varenicline in the previous 3 months * current (past 14 days) use of antipsychotic or antidepressant * an allergy to bupropion or varenicline * untreated hypertension or baseline systolic blood pressure \> 180 or diastolic \> 100 * have another member of their household already participating in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Point Prevalence Smoking Abstinence at 12 Weeks: the Number of Patients Who Refrained From Smoking at 12 Weeks | 12 weeks | Smoking abstinence biochemically confirmed with exhaled carbon monoxide concentrations |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Point Prevalence Smoking Abstinence at 6 Months: the Number of Patients Who Refrained From Smoking at 6 Months | 6 months | Smoking abstinence biochemically confirmed with exhaled carbon monoxide concentrations |
Countries
United States
Participant flow
Recruitment details
Patient's were recruited between 10 September, 2007 and 25 October, 2007 in the community surrounding the Mayo Clinic in Rochester Minnesota.
Pre-assignment details
Patients were excluded for not meeting entry criteria
Participants by arm
| Arm | Count |
|---|---|
| Medication Arm Varenicline 1.0 mg po bid plus bupropion 150 mg po bid | 38 |
| Total | 38 |
Baseline characteristics
| Characteristic | Medication Arm |
|---|---|
| Age Continuous | 49.1 years STANDARD_DEVIATION 12.4 |
| Cigarettes per day | 19.9 cigarettes per day STANDARD_DEVIATION 7.8 |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 25 / 38 |
| serious Total, serious adverse events | 0 / 38 |
Outcome results
Primary
Point Prevalence Smoking Abstinence at 12 Weeks: the Number of Patients Who Refrained From Smoking at 12 Weeks
Smoking abstinence biochemically confirmed with exhaled carbon monoxide concentrations
Time frame: 12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Medication Arm | Point Prevalence Smoking Abstinence at 12 Weeks: the Number of Patients Who Refrained From Smoking at 12 Weeks | 27 Participants |
Secondary
Point Prevalence Smoking Abstinence at 6 Months: the Number of Patients Who Refrained From Smoking at 6 Months
Smoking abstinence biochemically confirmed with exhaled carbon monoxide concentrations
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Medication Arm | Point Prevalence Smoking Abstinence at 6 Months: the Number of Patients Who Refrained From Smoking at 6 Months | 22 Participants |