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Project 1, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in Childbearing Age Women

NCT02250534 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 775

Last updated 2022-12-01

Study results available
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Summary

This study will examine extended exposure to cigarettes varying in nicotine content among disadvantaged women. Disadvantaged women are at increased risk for smoking, nicotine dependence, and using high nicotine yield cigarettes and are also at significantly increased risk for smoking-related adverse health consequences, including cervical cancer, thrombosis related to hormone-based contraception, infertility, and early menopause. Studies testing an innovative regulatory strategy of reducing the nicotine content of cigarettes to a non-addictive level have shown promising beneficial effects (decreased smoking rate, reduced toxicant exposure, and increased cessation) in the general population of smokers. However, these studies have uniformly excluded vulnerable populations like disadvantaged women who may respond differently considering their greater vulnerability to smoking and nicotine dependence. Thus, little is known scientifically about how this highly vulnerable subgroup of smokers might respond to a nicotine reduction policy. This project is designed to address that substantial knowledge gap. This same study was also conducted in two additional vulnerable populations under a similar protocol.

Conditions

  • Tobacco Use Disorder

Interventions

OTHER

Very low nicotine content cigarettes

Sponsors & Collaborators

  • Johns Hopkins University

    collaborator OTHER

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • University of Vermont

    lead OTHER

Principal Investigators

  • Stephen T. Higgins, Ph.D. · University of Vermont

  • Sarah H. Heil, Ph.D. · University of Vermont

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
44 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2019-10-31
Completion
2019-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02250534 on ClinicalTrials.gov