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Clinical Trials/NCT02019459
NCT02019459CompletedPhase 2

Very Low Nicotine Cigarettes in Smokers With Schizophrenia

Brown University2 sites in 1 country58 target enrollmentStarted: November 17, 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
58
Locations
2
Primary Endpoint
Number of cigarettes smoked per day

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

0.8 mg nicotine with 10.5 mg tar

Active Comparator

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: standard nicotine content cigarettes (Other)

0.03 mg nicotine with 9 mg tar

Experimental

SPECTRUM Cigarette: 0.03 mg (± 0.02) nicotine yield with 9 mg (± 1.5) tar

Intervention: Very low nicotine content cigarettes (Other)

Outcomes

Primary Outcomes

Number of cigarettes smoked per day

Time Frame: End of 6 week intervention

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jennifer Tidey

Principal Investigator

Brown University

Study Sites (2)

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