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

Duke University

Status and phase: Withdrawn; Phase 2

Conditions: Nicotine Dependence

Treatments: Other: Placebo ENDS; Other: Placebo patch; Drug: Nicotine patch; Other: ENDS

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02487953

Pro00063900

P50DA027840 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

Cigarette smokers, who are motivated to quit smoking but who rate the inhalation aspects of smoking as important will be randomized to three groups: Group 1. Nicotine ENDS + nicotine patch; Group 2: Nicotine ENDS + placebo patch; Group 3: Placebo ENDS + Nicotine patch. Participants will initially receive 1 week of 21 mg nicotine (or placebo) skin patches while continuing to smoke their usual cigarettes ad lib, in order to assess responsiveness to Nicotine Replacement Therapy (NRT). Starting with week 2, participants will receive nicotine-containing (or placebo) ENDS devices (menthol or non-menthol versions in accordance with their baseline preference). They will also be instructed to substitute ENDS for as many cigarettes as possible in this week. The target quit-smoking date will occur at the beginning of week 3. Treatments will continue until week 8 post-quit, at which time participants will be instructed to reduce ENDS use over the next 4 weeks, at which time ENDS will no longer be dispensed. Subsequently, the nicotine patch dose will be gradually reduced according to standard weaning regimen from 21 mg/24 h to 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. All nicotine-based treatments will end at week 16 after the quit date.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

0 participants in 3 patient groups

Nicotine ENDS + Nicotine Patch

Experimental group

Description:

Participants will initially receive 1 week of 21 mg nicotine skin patches while continuing to smoke their usual cigarettes ad lib. Starting with week 2, they will receive nicotine-containing ENDS devices and will be instructed to substitute ENDS for as many cigarettes as possible in this week. The target quit-smoking date will occur at the beginning of week 3. Treatments will continue until week 8 post-quit, at which time participants will be instructed to reduce ENDS use over the next 4 weeks, at which time ENDS will no longer be dispensed. Subsequently, the nicotine patch dose will be gradually reduced according to standard weaning regimen from 21 mg/24 h to 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. All nicotine-based treatments will end at week 16 after the quit date.

Treatment:

Other: ENDS

Drug: Nicotine patch

Nicotine ENDS + Placebo Patch

Active Comparator group

Description:

Participants will initially receive 1 week of placebo skin patches while continuing to smoke their usual cigarettes ad lib. Starting with week 2, they will receive nicotine-containing ENDS devices and will be instructed to substitute ENDS for as many cigarettes as possible in this week. The target quit-smoking date will occur at the beginning of week 3. Treatments will continue until week 8 post-quit, at which time participants will be instructed to reduce ENDS use over the next 4 weeks, at which time ENDS will no longer be dispensed. Subsequently, the placebo patch size will be gradually reduced to mirror standard weaning regimen from 21 mg/24 h to 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. All nicotine-based treatments will end at week 16 after the quit date.

Treatment:

Other: ENDS

Other: Placebo patch

Placebo ENDS + Nicotine Patch

Active Comparator group

Description:

Participants will initially receive 1 week of 21 mg nicotine skin patches while continuing to smoke their usual cigarettes ad lib. Starting with week 2, they will receive placebo ENDS devices and will be instructed to substitute ENDS for as many cigarettes as possible in this week. The target quit-smoking date will occur at the beginning of week 3. Treatments will continue until week 8 post-quit, at which time participants will be instructed to reduce ENDS use over the next 4 weeks, at which time ENDS will no longer be dispensed. Subsequently, the nicotine patch dose will be gradually reduced according to standard weaning regimen from 21 mg/24 h to 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. All nicotine-based treatments will end at week 16 after the quit date.

Treatment:

Drug: Nicotine patch

Other: Placebo ENDS