NCT02964182

Very Low Nicotine Content Cigarettes and E-Cigarettes in Promoting Smoking Cessation in Daily and Intermittent Cigarette Smokers

Evaluating Concomitant Use of Very Low Nicotine Content Cigarettes and E-Cigarettes Among Daily and Non-Daily Smokers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 213 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This trial studies what would happen if the nicotine levels in cigarettes are greatly reduced, but electronic cigarettes containing different amount of nicotine are available. Different levels of nicotine may effect certain behaviors, including withdrawal symptoms, nicotine cravings, and mood and may lead to changes in smoking behavior in current daily and intermittent smokers..

Detailed description

PRIMARY OBJECTIVES: I. To characterize the effects of switching to VLNCCs plus ECIG-Hi or ECIG-Lo nicotine doses on abuse liability among daily and intermittent smokers. EXPLORATORY OBJECTIVES: I. To explore the effects of switching to VLNCCs plus ECIG-Hi or ECIG-Lo nicotine doses on abuse liability using biochemical measures of product use, compensation, and toxicant exposure, and self-reported measures of withdrawal, craving, affect, and satisfaction. II. To explore the effects of switching from usual-brand cigarettes to VLNCCs, and from VLNCCs to VLNCC+ECIGs on measures of abuse liability. III. To characterize the effects of dual use of VLNCC and JUUL ECIGs on abuse liability. OUTLINE: PHASE I: Patients smoke their usual cigarettes brand during week 1. PHASE II: Patients smoke VLNCC cigarettes provided during weeks 2-4. PHASES III-IV: Patients are randomized to 1 of 2 arms. ARM I: Patients smoke ECIG-high (Hi) for 3 weeks and then ECIG-low (Lo) for 3 weeks ARM II: Patients smoke ECIG-Lo for 3 weeks and then ECIG-Hi for 3 weeks. After completion of study, patients are followed up for 30 days.

Conditions

• Cigarette Smoking-Related Carcinoma
• Tobacco-Related Carcinoma

Interventions

Type	Name	Description
DRUG	Cigarette	Smoke usual brand of cigarettes
DRUG	Nicotine Replacement	Received NRT (Electronic Cigarette - ECIG-Hi)
DRUG	Nicotine Replacement	Received NRT (Electronic Cigarette - ECIG-Hi)
OTHER	Questionnaire Administration	Ancillary studies
OTHER	Survey Administration	Ancillary studies
DRUG	Very Low Nicotine Content Cigarette	Smoke very low nicotine content cigarette
DEVICE	ECIG-Hi	Patients smoke ECIG-Hi for 3 weeks and then ECIG-Lo for 3 weeks.
DEVICE	ECIG-Lo	Patients smoke ECIG-Lo for 3 weeks and then ECIG-Hi for 3 weeks

Timeline

• Start date: 2017-10-26
• Primary completion: 2025-03-04
• Completion: 2025-03-04
• First posted: 2016-11-16
• Last updated: 2025-12-09
• Results posted: 2025-12-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study