Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
18 participants
INTERVENTIONAL
2017-01-31
2019-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
SINGLE
Study Groups
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Usual brand cigarettes
During one session, participants will smoke their usual brand cigarettes
Usual brand cigarettes
Usual brand cigarettes
Lower nicotine content cigarettes
During one session, participants will smoke SPECTRUM Research Cigarettes
Lower nicotine content cigarettes
SPECTRUM research cigarettes
Electronic cigarettes 1
During one session, participants will use an electronic cigarette with 0 mg/mL nicotine e-liquid
Electronic cigarettes 1
Electronic cigarette with 0 g/mL e-liquid
Electronic cigarettes 2
During one session, participants will use an electronic cigarette with 18 mg/mL nicotine e-liquid
Electronic cigarettes 2
Electronic cigarette with 18 g/mL e-liquid
Interventions
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Usual brand cigarettes
Usual brand cigarettes
Lower nicotine content cigarettes
SPECTRUM research cigarettes
Electronic cigarettes 1
Electronic cigarette with 0 g/mL e-liquid
Electronic cigarettes 2
Electronic cigarette with 18 g/mL e-liquid
Eligibility Criteria
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Inclusion Criteria
2. Self-report smoking ≥10 cigarettes/day of a brand delivering \>0.5mg nicotine for \>2yrs
3. Have afternoon expired CO concentrations of ≥10ppm or morning urinary cotinine \>100ng/ml (as measured with NicAlert)
Exclusion Criteria
2. Acute intoxication as measured by breath alcohol level (BAL) \> 0
3. Current use of nicotine replacement or other pharmacotherapy for smoking cessation
4. Previous use of e-cigarettes
5. Use of other tobacco products (e.g., chew tobacco, cigars) on \> 10 of the past 30 days
6. Unstable HIV or associated comorbidities, as determined by a licensed medical professional.
7. Pregnancy (Females testing positive for pregnancy and any participants wishing to quit immediately will be referred to community smoking cessation treatment and will be excluded from the study)
8. Blood pressure at or above 160/100 or below 90/50
9. Heart rate at or above 105 bpm or below 45 bpm
18 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Duke University
OTHER
Responsible Party
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Principal Investigators
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F. Joseph McClernon, PhD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Duke University School of Medicine
Durham, North Carolina, United States
Countries
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Other Identifiers
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Pro00067757
Identifier Type: -
Identifier Source: org_study_id
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