Combination Bupropion / Varenicline for Smoking Cessation in Male Smokers

Completed · Phase 2

Conditions studied: Nicotine Dependence

In brief

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.

Key facts

Study ID

NCT01806779

Run by

Duke University

People needed

376

Starts

2013-03-01

Expected to finish

2015-03-01

Last updated by the study team

2016-01-18

Who can join

Age: 18 and older, up to 65. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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 carbon monoxide (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 protocol;
• 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.

You may not qualify if…

• Hypertension;
• Hypotension with symptoms;
• Coronary heart disease;
• Lifetime history of heart attack;
• Cardiac rhythm disorder (irregular heart rhythm);
• Chest pains (unless history, exam, and electrocardiogram (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 disorder);
• 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 suicide;
• 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;

Where it is running

• Duke Center for Smoking Cessation — Charlotte, North Carolina, United States
• Duke Center for Smoking Cessation — Durham, North Carolina, United States
• Duke Center for Smoking Cessation — Raleigh, North Carolina, United States
• Duke Center for Smoking Cessation — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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