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OpenTrials
Completed

NCT Number: NCT02019459

Very Low Nicotine Cigarettes in Smokers With Schizophrenia

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.

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Key information

Conditions

Tobacco Dependence Chemically-Induced Disorders Mental Disorders Substance-Related Disorders Tobacco Use Disorder

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Brown University

Providence, Rhode Island, 02912, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Very low nicotine content cigarettes

Other

standard nicotine content cigarettes

Other

Primary outcomes

  1. Number of cigarettes smoked per day

    Time frame: End of 6 week intervention

Sponsors and collaborators

Lead sponsor

Brown University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • University of Pittsburgh

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Dec 24, 2013
Registry last updated
Apr 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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