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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02232737
Recruitment Status : Completed
First Posted : September 5, 2014
Last Update Posted : June 11, 2020
Sponsor:
Collaborator:
University of Vermont
Information provided by (Responsible Party):
Jennifer Tidey, Brown University

Tracking Information
First Submitted Date  ICMJE September 3, 2014
First Posted Date  ICMJE September 5, 2014
Last Update Posted Date June 11, 2020
Actual Study Start Date  ICMJE October 7, 2016
Actual Primary Completion Date January 14, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 4, 2014)
Cigarettes per day [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Project 3, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in People With Current Affective Disorders
Official Title  ICMJE Project 3, Study 2: Extended Exposure to Low Nicotine Content Cigarettes in People With Current Affective Disorders
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Tobacco Use Disorder
Intervention  ICMJE Other: Very low nicotine content cigarettes
Study Arms  ICMJE
  • Experimental: 0.8 mg nicotine
    0.8 mg nicotine cigarettes
    Intervention: Other: Very low nicotine content cigarettes
  • Experimental: 0.12 mg nicotine
    0.12 mg nicotine cigarettes
    Intervention: Other: Very low nicotine content cigarettes
  • Experimental: 0.03 mg nicotine
    0.03 mg nicotine cigarettes
    Intervention: Other: Very low nicotine content cigarettes
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 15, 2019)
270
Original Estimated Enrollment  ICMJE
 (submitted: September 4, 2014)
405
Actual Study Completion Date  ICMJE January 14, 2019
Actual Primary Completion Date January 14, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02232737
Other Study ID Numbers  ICMJE P50DA036114:P3S2
P50DA036114 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jennifer Tidey, Brown University
Study Sponsor  ICMJE Brown University
Collaborators  ICMJE University of Vermont
Investigators  ICMJE
Study Director: Stephen T Higgins, PhD University of Vermont
PRS Account Brown University
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP