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Very Low Nicotine Cigarettes in Smokers With Schizophrenia

This study is currently recruiting participants.
Verified August 2016 by Jennifer Tidey, Brown University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02019459
First Posted: December 24, 2013
Last Update Posted: August 3, 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)
University of Pittsburgh
Information provided by (Responsible Party):
Jennifer Tidey, Brown University
  Purpose
Smokers with schizophrenia (SWS) 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 this population. 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.

Condition Intervention Phase
Tobacco Dependence Other: Very low nicotine content cigarettes Other: standard nicotine content cigarettes Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Very Low Nicotine Cigarettes in Smokers With Schizophrenia

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Number of cigarettes smoked per day [ Time Frame: End of 6 week intervention ]

Estimated Enrollment: 80
Study Start Date: November 2014
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
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
Other: Very low nicotine content cigarettes

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnant or nursing
  • Seeking treatment for smoking
  • Medical contraindications
  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): NCT02019459


Contacts
Contact: Jennifer Tidey, Ph.D. (401) 863-6418 jennifer_tidey@brown.edu

Locations
United States, Rhode Island
Brown University Recruiting
Providence, Rhode Island, United States, 02912
Principal Investigator: Jennifer Tidey, Ph.D.         
Sponsors and Collaborators
Brown University
National Institute on Drug Abuse (NIDA)
University of Pittsburgh
Investigators
Principal Investigator: Jennifer Tidey, Ph.D. Brown University
  More Information

Responsible Party: Jennifer Tidey, Principal Investigator, Brown University
ClinicalTrials.gov Identifier: NCT02019459     History of Changes
Other Study ID Numbers: 5U54DA031659-03 ( U.S. NIH Grant/Contract )
First Submitted: December 18, 2013
First Posted: December 24, 2013
Last Update Posted: August 3, 2016
Last Verified: August 2016

Additional relevant MeSH terms:
Nicotine
Schizophrenia
Tobacco Use Disorder
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Substance-Related Disorders
Chemically-Induced 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