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Very Low Nicotine Cigarettes in Smokers With Schizophrenia

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: NCT02019459
Recruitment Status : Completed
First Posted : December 24, 2013
Last Update Posted : April 9, 2018
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
University of Pittsburgh
Information provided by (Responsible Party):
Jennifer Tidey, Brown University

Tracking Information
First Submitted Date  ICMJE December 18, 2013
First Posted Date  ICMJE December 24, 2013
Last Update Posted Date April 9, 2018
Actual Study Start Date  ICMJE November 17, 2014
Actual Primary Completion Date August 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 23, 2013)
Number of cigarettes smoked per day [ Time Frame: End of 6 week intervention ]
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 Very Low Nicotine Cigarettes in Smokers With Schizophrenia
Official Title  ICMJE Very Low Nicotine Cigarettes in Smokers With Schizophrenia
Brief Summary Smokers with serious mental illness including those with schizophrenia and bipolar disorder infrequently attempt and attain sustained smoking abstinence and have a 25-year shorter lifespan due to smoking-related illness. This study will examine whether reducing the nicotine content of cigarettes to non-addicting levels is a viable method of reducing smoking in smokers with serious mental illness. Smokers will be randomized to one of two experimental conditions: 1) very low nicotine content (VLNC) cigarettes or 2) normal nicotine content (NNC) cigarettes. Participants will be assessed for patterns of tobacco use, biomarkers of exposure, subjective responses (e.g., satisfaction, craving, withdrawal symptoms), psychiatric symptoms, cognitive performance, smoking cue reactivity and smoking topography.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Tobacco Dependence
Intervention  ICMJE
  • Other: Very low nicotine content cigarettes
  • Other: standard nicotine content cigarettes
Study Arms  ICMJE
  • Active Comparator: 0.8 mg nicotine with 10.5 mg tar
    SPECTRUM Cigarette: 0.8 (±0.15) mg nicotine yield with 9 (±1.5) mg tar (standard nicotine and tar yields of commercially-available cigarettes; control condition)
    Intervention: Other: standard nicotine content cigarettes
  • Experimental: 0.03 mg nicotine with 9 mg tar
    SPECTRUM Cigarette: 0.03 mg (± 0.02) nicotine yield with 9 mg (± 1.5) tar
    Intervention: Other: Very low nicotine content cigarettes
Publications * Not Provided

*   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: April 5, 2018)
58
Original Estimated Enrollment  ICMJE
 (submitted: December 23, 2013)
80
Actual Study Completion Date  ICMJE August 31, 2017
Actual Primary Completion Date August 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 18-70
  • Schizophrenia, schizoaffective disorder or bipolar disorder
  • Smoke an average of at least 10 cigarettes per day for at least 1 year
  • Breath carbon monoxide (CO) levels >8 ppm (if ≤ 8 ppm, then nicotine (NicAlert) Strip > 2)

Exclusion Criteria:

  • Pregnant or nursing
  • Seeking treatment for smoking
  • Medical contraindications
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
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 NCT02019459
Other Study ID Numbers  ICMJE 5U54DA031659-03( 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
  • National Institute on Drug Abuse (NIDA)
  • University of Pittsburgh
Investigators  ICMJE
Principal Investigator: Jennifer Tidey, Ph.D. Brown University
PRS Account Brown University
Verification Date April 2018

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