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

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..

Conditions

• Cigarette Smoking-Related Carcinoma
• Tobacco-Related Carcinoma

Interventions

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

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• M.D. Anderson Cancer Center

  lead OTHER

Principal Investigators

• Paul Cinciripini · M.D. Anderson Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-10-26

Primary Completion

2025-03-04

Completion

2025-03-04

FDA Device

Yes

Countries

• United States

Study Locations