Electronic Nicotine Delivery Systems as a Smoking Cessation Treatment (ENDS-P50)

This is an interventional treatment trial for Nicotine Dependence focused on measuring Nicotine addiction, Cigarette smoking, Smoking cessation, Nicotine patches, E-cigarettes Read More

Inclusion Criteria:

• Have no known serious medical conditions;
• Smoke an average of at least 10 cigarettes per day;
• Have an expired air CO reading of at least 15 ppm;
• Able to read and understand English;
• Express a desire to quit smoking in the next thirty days;
• Higher than median rating of enjoyment of airway sensory effects of inhaling smoke on Cigarette Evaluation Questionnaire.

Exclusion Criteria:

• Hypertension;
• Hypotension;
• 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;
• Ulcers;
• 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);
• History of migraine headaches in the past 5 years;
• History of fainting;
• Problems giving blood samples;
• Difficulty passing urine;
• 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;
• Pregnant or nursing mothers;

• 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), cigars, pipes, nicotine replacement therapy, e-cigarettes or other smoking cessation treatment;;
• Alcohol abuse;
• Significant adverse reaction to nicotine patches 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.

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.