Electronic Nicotine Delivery Systems as a Smoking Cessation Treatment
Withdrawn before enrolling · Phase 2 · Has a placebo group
Conditions studied: Nicotine Dependence
In brief
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.
Key facts
- Study ID
- NCT02487953
- Run by
- Duke University
- People needed
- 0
- Starts
- 2018-07-01
- Expected to finish
- 2022-01-01
- Last updated by the study team
- 2018-09-12
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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;
Where it is running
- Duke Center for Smoking Cessation — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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