Electronic Nicotine Delivery Systems as a Smoking Cessation Treatment

Trial end date:
Target enrollment:
Participant gender:
The purpose of this research study is to determine whether combining electronic nicotine delivery systems (ENDS) with nicotine patch treatment will augment abstinence rates compared to either treatment alone.
Phase 2
Accepts Healthy Volunteers?
Lead Sponsor:
Duke University
National Institute on Drug Abuse (NIDA)
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

- 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

- 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

- 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.