Electronic Nicotine Delivery Systems (ENDS) as a Smoking Cessation Treatment
Overview
- Phase
- Phase 2
- Intervention
- Nicotine patch
- Conditions
- Nicotine Dependence
- Sponsor
- Duke University
- Locations
- 1
- Primary Endpoint
- Continuous four-week abstinence from smoking during treatment
- Status
- Withdrawn
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Detailed 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.
Investigators
Eligibility Criteria
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);
Arms & Interventions
Nicotine ENDS + Nicotine Patch
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.
Intervention: Nicotine patch
Nicotine ENDS + Nicotine Patch
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.
Intervention: ENDS
Nicotine ENDS + Placebo Patch
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.
Intervention: ENDS
Nicotine ENDS + Placebo Patch
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.
Intervention: Placebo patch
Placebo ENDS + Nicotine Patch
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.
Intervention: Nicotine patch
Placebo ENDS + Nicotine Patch
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.
Intervention: Placebo ENDS
Outcomes
Primary Outcomes
Continuous four-week abstinence from smoking during treatment
Time Frame: Weeks 4-8 post target Quit Day
The primary outcome measure will be continuous four-week abstinence from smoking during weeks 4-8 post target Quit Day while treatment is ongoing. This will be determined by a composite of self-report of no smoking on daily diaries and expired air carbon monoxide (CO) \<10 ppm (measured at Week 8). An intent-to-treat criterion will be used, whereby drop-outs are considered to be non-abstinent.
Secondary Outcomes
- Continuous four-week abstinence from smoking after withdrawal of ENDS(Weeks 9-12 post target Quit Day)
- Continuous four-week abstinence from smoking after withdrawal of nicotine patches(Weeks 13-16 post target Quit Day)
- Seven-day point abstinence from smoking at 6 months post Quit Day(6 months post Quit Day)