NCT02487953

Electronic Nicotine Delivery Systems as a Smoking Cessation Treatment

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nicotine Dependence

Interventions

Type	Name	Description
DRUG	Nicotine patch	21 mg/24 h for 2 weeks before the quit date and 12 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.
OTHER	ENDS	As needed for 1 week before the quit date and 8 weeks after the quit date, then reduced use for 4 weeks.
OTHER	Placebo patch	21 mg size for 2 weeks before the quit date and 12 weeks after the quit date, 14 mg size for 2 weeks, and 7 mg size for 2 weeks.
OTHER	Placebo ENDS	As needed for 1 week before the quit date and 8 weeks after the quit date, then reduced use for 4 weeks.

Timeline

• Start date: 2018-07-01
• Primary completion: 2020-01-01
• Completion: 2022-01-01
• First posted: 2015-07-02
• Last updated: 2018-09-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study