Effects of Cigar Flavors on Measures of Abuse Liability Among Young Adults
NCT ID: NCT02937051
Last Updated: 2019-04-23
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
25 participants
INTERVENTIONAL
2016-10-31
2019-04-12
Brief Summary
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1. own-brand CTC (positive control),
2. original-flavored Black \& Mild (B\&M) cigar,
3. apple-flavored B\&M cigar,
4. cream-flavored B\&M cigar, and
5. wine-flavored B\&M cigar.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
SINGLE
Study Groups
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Own Brand Cigarette Condition
Tobacco product administration and assessment
two bouts of 10 puffs of a tobacco product with a 30-second interpuff interval separated by 60 minutes; preceded and followed by physiological, subjective and topography assessment
Original-flavor Black&Mild cigar
Tobacco product administration and assessment
two bouts of 10 puffs of a tobacco product with a 30-second interpuff interval separated by 60 minutes; preceded and followed by physiological, subjective and topography assessment
Apple-flavor Black&Mild cigar
Tobacco product administration and assessment
two bouts of 10 puffs of a tobacco product with a 30-second interpuff interval separated by 60 minutes; preceded and followed by physiological, subjective and topography assessment
Cream-flavor Black&Mild cigar
Tobacco product administration and assessment
two bouts of 10 puffs of a tobacco product with a 30-second interpuff interval separated by 60 minutes; preceded and followed by physiological, subjective and topography assessment
Wine-flavor Black&Mild cigar
Tobacco product administration and assessment
two bouts of 10 puffs of a tobacco product with a 30-second interpuff interval separated by 60 minutes; preceded and followed by physiological, subjective and topography assessment
Interventions
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Tobacco product administration and assessment
two bouts of 10 puffs of a tobacco product with a 30-second interpuff interval separated by 60 minutes; preceded and followed by physiological, subjective and topography assessment
Eligibility Criteria
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Inclusion Criteria
* They must agree to attend the lab and abstain from tobacco/nicotine as required, to use the designated products, and to follow the study protocol.
* Participants must also be regular CTC smokers (≥5 cigarettes/day for past 3 months) naïve to cigar products (smoked no more than 10 cigar products of any type in lifetime) who can provide a semi-quantitative urine cotinine result of ≥3 at screening (NicAlert test).
Exclusion Criteria
* Individuals who report using marijuana or alcohol \>20 days in the past 30 or interest in quitting CTC use within the next 30 days will also be excluded.
* Women will be excluded if they are breast-feeding or test positive for pregnancy (by urinalysis) at screening.
18 Years
21 Years
ALL
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
Virginia Commonwealth University
OTHER
Responsible Party
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Principal Investigators
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Andrew J Barnes, PhD
Role: PRINCIPAL_INVESTIGATOR
Virginia Commonwealth University
Locations
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VCU Behavioral Health Research Laboratory
Richmond, Virginia, United States
Countries
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References
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Wall CS, Bono RS, Lester RC, Hoetger C, Lipato T, Guy MC, Eissenberg TE, Bickel WK, Barnes AJ, Cobb CO. Triangulating abuse liability assessment for flavoured cigar products using physiological, behavioural economic and subjective assessments: a within-subjects clinical laboratory protocol. BMJ Open. 2018 Oct 10;8(10):e023850. doi: 10.1136/bmjopen-2018-023850.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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HM20007848
Identifier Type: -
Identifier Source: org_study_id
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