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Very Low Nicotine Cigarettes in Smokers With Schizophrenia

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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

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.

Condition or disease Intervention/treatment Phase
Tobacco Dependence Other: Very low nicotine content cigarettes Other: standard nicotine content cigarettes Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
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
Actual Study Start Date : November 17, 2014
Actual Primary Completion Date : August 31, 2017
Actual Study Completion Date : August 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
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



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


Information from the National Library of Medicine

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

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

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


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

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 Posted: December 24, 2013    Key Record Dates
Last Update Posted: April 9, 2018
Last Verified: April 2018

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