The Role of Nicotine Dose and Route of Delivery in Affecting Adoption of E-cigarettes and Reducing Exposure to Toxic Combustion Products

Completed · Phase 2 · Has a placebo group

Conditions studied: Nicotine Dependence, Cigarettes

In brief

This study plans to investigate whether using electronic cigarettes (e-cigarettes) or skin patches containing nicotine affects switching from smoking conventional combustible (burning) cigarettes.

Key facts

Study ID

NCT03492463

Run by

Duke University

People needed

94

Starts

2018-08-06

Expected to finish

2021-05-31

Last updated by the study team

2023-02-08

Who can join

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

You may qualify if…

• 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;
• Have a body weight of > 110 lbs. (50 kg) and ≤ 300 lbs. (136 kg);
• Are able to read and understand English;
• Potential subjects of child bearing potential must agree to use acceptable contraception during their participation in this study. Potential subjects must agree to avoid the following during their participation in this study:
• Participation in any other nicotine-related modification strategy outside of this protocol;
• Use of tobacco products other than cigarettes, including pipe tobacco, cigars, snuff, and chewing tobacco;
• Use of e-cigarettes other than the ones provided during the study;
• Use of experimental (investigational) drugs or devices;
• Use of illegal drugs;
• Use of exclusionary medications.

You may not qualify if…

• Seeking treatment for nicotine dependence.
• Hypertension - systolic BP > 160 mm Hg, diastolic BP > 100 mm Hg. Individuals with a history of hypertension may be allowed to participate in the study if the study physician or medical provider determines that the condition is stable and will not jeopardize the individual's safety.
• Hypotension (with symptoms) - systolic BP < 90 mm Hg, diastolic BP < 60 mm Hg.
• Coronary heart disease with symptoms (e.g., chest pain)
• Heart attack in the past year
• Cardiac rhythm disorder (irregular heart rhythm with symptoms)
• Chest pain in the last month (unless history indicates a non-cardiac source)
• Symptomatic heart disorder such as heart failure
• Advanced liver or kidney disease that requires medication or dialysis, paracentesis
• Major gastrointestinal illness (e.g. Celiac disease, Crohn's dx Ulcerative Colitis)
• Bleeding stomach ulcers in the past 30 days
• Lung disease that requires oxygen
• Major brain disorder (including stroke with residual deficit, brain tumor, and seizure disorder)
• Migraine headaches that occur more frequently than once per week
• Recent, unexplained fainting spells
• Problems giving blood samples
• Diabetes with insulin use or with HbA1C over 7%
• Current cancer or treatment for cancer in the past six months (except basal or squa-mous cell skin cancer)
• HIV, Hepatitis B, or Hepatitis C
• History of Tuberculosis or recent positive purified protein derivative (PPD)
• Other major medical condition (as determined by study physician)
• Currently symptomatic psychiatric disease (as determined by study physician)
• Psychosis, bipolar disorder, or psychiatric hospitalization within the past 12 months
• Suicidal ideation (thinking about ways to commit suicide) (within the past 12 months) or a lifetime occurrence of attempted suicide;
• Current depression - The Patient Health Questionnaire PHQ-9 for Depression will be used to screen for current (within 2 weeks) depression. Potential subjects who score >9 (or who score >0 on item #9 ("Thoughts that you would be better off dead, or of hurting yourself in some way") will be excluded from study participation, and, at the discretion of the study physician, referred to appropriate psychiatric treatment;

Where it is running

• Duke Center for Smoking Cessation — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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