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

This study is currently recruiting participants.
Verified October 2016 by Stephen T. Higgins, University of Vermont
Sponsor:
ClinicalTrials.gov Identifier:
NCT02250534
First Posted: September 26, 2014
Last Update Posted: October 6, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
National Institute on Drug Abuse (NIDA)
Johns Hopkins University
Information provided by (Responsible Party):
Stephen T. Higgins, University of Vermont
  Purpose
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 worn 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.

Condition Intervention Phase
Tobacco Use Disorder Other: Very low nicotine content cigarettes Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Project 1, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in Childbearing Age Women

Resource links provided by NLM:


Further study details as provided by Stephen T. Higgins, University of Vermont:

Primary Outcome Measures:
  • Cigarettes per day [ Time Frame: 12 weeks ]

Estimated Enrollment: 282
Study Start Date: October 2016
Estimated Study Completion Date: October 2019
Estimated Primary Completion Date: October 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 0.8 mg nicotine
0.8 mg nicotine very low nicotine content cigarettes
Other: Very low nicotine content cigarettes
Experimental: 0.12 mg nicotine
0.12 mg nicotine very low nicotine content cigarettes
Other: Very low nicotine content cigarettes
Experimental: 0.03 mg nicotine
0.03 mg nicotine very low nicotine content cigarettes
Other: Very low nicotine content cigarettes

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 44 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female
  • Ages 18-44 years
  • Less than an Associate's degree
  • Report smoking ≥ 5 cigarettes per day
  • Provide an intake breath CO sample > 8 ppm
  • Be without current (within the past year) serious mental disorder that would interfere with study results or completion as determined by the Licensed Medical Professional or PI
  • Be without current substance abuse/dependence other than nicotine
  • Be sufficiently literate to complete research-related tasks
  • Be in good physical health without serious illness or change in health or medication in the past three months as determined by the Licensed Medical Professional at each site
  • Not pregnant or nursing and report using oral, implant, patch, ring, IUD, injection, or barrier contraceptives or report being surgically sterile, or post menopausal
  • Report no significant use of other tobacco or nicotine products within the past month (> 9 days in the past 30)

Exclusion Criteria:

  • Any prior regular use (used as primary cigarette outside of the laboratory) of Spectrum cigarettes (i.e., research cigarettes with reduced nicotine content)
  • Exclusive use of roll-your-own cigarettes
  • Planning to quit smoking in the next 30 days
  • A quit attempt in the past 30 days resulting in > 3 days of abstinence
  • Currently taking anticonvulsant medications
  • Positive toxicology screen for illicit drugs not including marijuana (participants with valid prescriptions will not be excluded and participants with a positive toxicology screen will be allowed to re-screen once)
  • Breath alcohol level > 0.01 (participants with a positive screen will be allowed to re-screen once)
  • Self-report of binge drinking alcohol (> 9 days in past 30, 4 drinks in 2 hours )
  • Systolic blood pressure < 90 or ≥ 160 mmHg (participants outside the range will be allowed to re-screen once)
  • Diastolic blood pressure < 50 or ≥ 100 mmHg (participants outside the range will be allowed to re-screen once)
  • Breath CO > 80 ppm
  • Heart rate < 45 or ≥ 115 bpm (participants outside the range will be allowed to re-screen once)
  • Currently seeking treatment for smoking cessation
  • Have used nicotine replacement, bupropion or other pharmacotherapies as cessation aids in the past month (bupropion for treatment of depression will be allowed)
  • Current symptoms of psychosis, dementia or mania
  • Suicidal ideation in the past month
  • Suicide attempt in past 6 months
  • Participation in another research study in the past 30 days
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02250534


Contacts
Contact: Lauren Tursi 802-656-8859 Lauren.Tursi@uvm.edu

Locations
United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21224
Principal Investigator: Maxine L Stitzer, PhD         
Sub-Investigator: Ryan Vandrey, PhD         
United States, Vermont
University of Vermont Recruiting
Burlington, Vermont, United States, 05401
Principal Investigator: Stephen T Higgins, PhD         
Principal Investigator: Sarah H Heil, PhD         
Sponsors and Collaborators
University of Vermont
National Institute on Drug Abuse (NIDA)
Johns Hopkins University
Investigators
Study Director: Stephen T. Higgins, Ph.D. University of Vermont
  More Information

Responsible Party: Stephen T. Higgins, Professor, University of Vermont
ClinicalTrials.gov Identifier: NCT02250534     History of Changes
Other Study ID Numbers: P50DA036114:P1S2
P50DA036114 ( U.S. NIH Grant/Contract )
First Submitted: September 23, 2014
First Posted: September 26, 2014
Last Update Posted: October 6, 2016
Last Verified: October 2016

Keywords provided by Stephen T. Higgins, University of Vermont:
Biomarkers of exposure
Compensatory smoking
Nicotine dependence
Reduced nicotine cigarettes
Tobacco withdrawal
Women
Health disparities
Vulnerable populations

Additional relevant MeSH terms:
Nicotine
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action