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Project 3, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in People With Current Affective Disorders

This study is currently recruiting participants.
Verified October 2016 by Jennifer Tidey, Brown University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02232737
First Posted: September 5, 2014
Last Update Posted: October 5, 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.
Collaborator:
University of Vermont
Information provided by (Responsible Party):
Jennifer Tidey, Brown University
  Purpose
This study will examine extended exposure to cigarettes varying in nicotine content among people with affective disorders. People with affective disorders are at an 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. 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 people with current affective disorders, 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 may respond to a nicotine reduction policy. This project is designed to fill 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 3, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in People With Current Affective Disorders

Resource links provided by NLM:


Further study details as provided by Jennifer Tidey, Brown University:

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 cigarettes
Other: Very low nicotine content cigarettes
Experimental: 0.12 mg nicotine
0.12 mg nicotine cigarettes
Other: Very low nicotine content cigarettes
Experimental: 0.03 mg nicotine
0.03 mg nicotine 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 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or Female
  • Ages 18-70
  • Past-year major depressive disorder, dysthymic disorder, generalized anxiety disorder, post-traumatic stress disorder, obsessive-compulsive disorder, phobia, or panic disorder with or without agoraphobia, based on MINI structured interview, OR lifetime diagnosis of one of the above based on MINI with a self-report of currently receiving treatment (prescribed psychoactive medication, behavioral therapy, etc.)
  • Report smoking 5 or more cigarettes per day for the past year
  • Provide an intake breath CO sample > 8 ppm
  • Be without current substance abuse/dependence other than nicotine
  • Be sufficiently literate to complete the research-related tasks
  • Be in good physical health without serious illness or change in health in the past 3 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
  • 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 the past 30, 4/5 drinks in 2 hours for women/men
  • Systolic blood pressure below 90 mmHg or greater than or equal to 160 mmHg (participants outside the range will be allowed to re-screen once)
  • Diastolic blood pressure below 50 mmHg or greater than or equal to 100 mmHg (participants outside the range will be allowed to re-screen once)
  • Breath CO > 80 ppm
  • Heart rate below 45 or greater than or equal to 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)
  • Unstable psychiatric conditions (psychiatric medication changes in the past 4 weeks)
  • Current symptoms of psychosis, dementia or mania
  • Suicidal ideation in 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): NCT02232737


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

Locations
United States, Rhode Island
Brown University Not yet recruiting
Providence, Rhode Island, United States, 02912
Contact    401-863-6418    Jennifer_Tidey@brown.edu   
Principal Investigator: Jennifer W Tidey, PhD         
Principal Investigator: Diann Gaalema, PhD         
United States, Vermont
University of Vermont Recruiting
Burlington, Vermont, United States, 05401
Contact: Stephen T Higgins, PhD    802-656-8859    Stephen.Higgins@uvm.edu   
Sponsors and Collaborators
Brown University
University of Vermont
Investigators
Study Director: Stephen T Higgins, PhD University of Vermont
  More Information

Responsible Party: Jennifer Tidey, Professor (Research), Brown University
ClinicalTrials.gov Identifier: NCT02232737     History of Changes
Other Study ID Numbers: P50DA036114:P3S2
P50DA036114 ( U.S. NIH Grant/Contract )
First Submitted: September 3, 2014
First Posted: September 5, 2014
Last Update Posted: October 5, 2016
Last Verified: October 2016

Keywords provided by Jennifer Tidey, Brown University:
Biomarkers of exposure
Compensatory smoking
Nicotine dependence
Reduced nicotine cigarettes
Tobacco withdrawal
Women
Health disparaties
Vulnerable populations

Additional relevant MeSH terms:
Nicotine
Disease
Tobacco Use Disorder
Mood Disorders
Pathologic Processes
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