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Combination Bupropion / Varenicline for Smoking Cessation in Male Smokers

Information source: Duke University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Nicotine Dependence

Intervention: Chantix (Drug); Zyban (Drug); Nicotine patches (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Duke University

Official(s) and/or principal investigator(s):
Jed E Rose, Ph.D., Principal Investigator, Affiliation: Duke University


Previous results from the investigators' Center have shown that combination treatment with Chantix and Zyban is more successful in helping men quit smoking. The investigators hope to replicate these findings with this study.

Clinical Details

Official title: Combination Bupropion / Varenicline for Smoking Cessation in Male Smokers

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Primary outcome: Continuous four-week abstinence from smoking

Secondary outcome:

Seven day point abstinence from smoking at 6 months post Quit Day

Continuous abstinence from smoking from Quit Day to end of treatment (week 11)


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Male.


Inclusion Criteria:

- Have no known serious medical conditions;

- Male;

- Are 18-65 years old;

- Smoke an average of at least 10 cigarettes per day;

- Have smoked at least one cumulative year;

- Have an expired air CO reading of at least 10ppm;

- Able to read and understand English;

- Express a desire to quit smoking in the next thirty days.

Potential subjects must agree to use acceptable contraception. Potential subjects must agree to avoid the following:

- participation in any other nicotine-related modification strategy outside of this


- use of tobacco products other than cigarettes, including pipe tobacco, cigars,

e-cigarettes, snuff, and chewing tobacco;

- use of experimental (investigational) drugs or devices;

- use of illegal drugs;

- use of opiate medications.

Exclusion Criteria:

- Hypertension;

- Hypotension with symptoms;

- Coronary heart disease;

- Lifetime history of heart attack;

- Cardiac rhythm disorder (irregular heart rhythm);

- Chest pains (unless history, exam, and ECG clearly indicate a non-cardiac source);

- Cardiac (heart) disorder (including but not limited to valvular heart disease, heart

murmur, heart failure);

- History of skin allergy;

- Active skin disorder (e. g., psoriasis) within the last five years;

- Liver or kidney disorder (except kidney stones, gallstones);

- Gastrointestinal problems or disease other than gastroesophageal reflux or heartburn;

- Active ulcers in the past 30 days;

- Currently symptomatic lung disorder/disease (including but not limited to Chronic

obstructive pulmonary disease (COPD), emphysema, and asthma);

- Brain abnormality (including but not limited to stroke, brain tumor, and seizure


- Migraine headaches that occur more frequently than once per week;

- Recent, unexplained fainting spells;

- Problems giving blood samples;

- Diabetes treated with insulin; non-insulin treated diabetes (unless glucose is less

than 180mg/dcl and HbA1c is less than 7%);

- Current cancer or treatment for cancer in the past six months (except basal or

squamous cell skin cancer);

- Other major medical condition;

- Current psychiatric disease (with the exception of anxiety disorders, Obsessive

Compulsive Disorder (OCD) and ADHD);

- Suicidal ideation (within the past 10 years) or lifetime occurrence of attempted


- Current depression;

- Bulimia or anorexia;

- Use of opiate medications for pain or sleep (non-opiate medication for pain or sleep

will be allowed) within the past 14 days;

- Smoking more than one cigar a month.

- Alcohol abuse;

- Significant adverse reaction to nicotine patches, bupropion / Wellbutrin / Zyban or

Chantix / varenicline in the past.

- Current participation or recent participation (in the past 30 days) in another

smoking study at our Center or another research facility.

- Current participation in another research study.

Use (within the past 30 days) of:

- Illegal drugs (or if the urine drug screen is positive for tetrahydrocannabinol

(THC), Cocaine, Amphetamine, Opiates, Methamphetamines, phencyclidine (PCP), Benzodiazepines, or Barbiturates),

- Experimental (investigational) drugs;

- Psychiatric medications including antidepressants, anti-psychotics or any other

medications that are known to affect smoking cessation (e. g. clonidine);

- Smokeless tobacco (chewing tobacco, snuff), pipes or e-cigarettes;

- Wellbutrin, bupropion, Zyban, Chantix, varenicline, nicotine replacement therapy or

any other smoking cessation aid.

Locations and Contacts

Duke Center for Smoking Cessation, Charlotte, North Carolina 28210, United States

Duke Center for Smoking Cessation, Durham, North Carolina 27705, United States

Duke Center for Smoking Cessation, Raleigh, North Carolina 27609, United States

Duke Center for Smoking Cessation, Winston-Salem, North Carolina 27103, United States

Additional Information

Starting date: March 2013
Last updated: June 9, 2015

Page last updated: August 23, 2015

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