Very Low Nicotine Cigarettes in Smokers With Schizophrenia
1 other identifier
interventional
58
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Nov 2014
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 18, 2013
CompletedFirst Posted
Study publicly available on registry
December 24, 2013
CompletedStudy Start
First participant enrolled
November 17, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2017
CompletedApril 9, 2018
April 1, 2018
2.8 years
December 18, 2013
April 5, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Number of cigarettes smoked per day
End of 6 week intervention
Study Arms (2)
0.8 mg nicotine with 10.5 mg tar
ACTIVE COMPARATORSPECTRUM 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)
0.03 mg nicotine with 9 mg tar
EXPERIMENTALSPECTRUM Cigarette: 0.03 mg (± 0.02) nicotine yield with 9 mg (± 1.5) tar
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Pregnant or nursing
- Seeking treatment for smoking
- Medical contraindications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Brown Universitylead
- National Institute on Drug Abuse (NIDA)collaborator
- University of Pittsburghcollaborator
Study Sites (1)
Brown University
Providence, Rhode Island, 02912, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jennifer Tidey, Ph.D.
Brown University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 18, 2013
First Posted
December 24, 2013
Study Start
November 17, 2014
Primary Completion
August 31, 2017
Study Completion
August 31, 2017
Last Updated
April 9, 2018
Record last verified: 2018-04