Clinical trial NCT02937051: Effects of Cigar Flavors on Measures of Abuse Liability Among Young Adults
Official title: Effects of Cigar Flavors on Measures of Abuse Liability Among Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Products
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2016-10-18
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 21
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study involves 25 current young adult combustible tobacco cigarette (CTC) smokers who will complete 5 Latin square ordered, within-subject, laboratory conditions that differ by the tobacco product smoked:

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.


Eligibility criteria: Inclusion Criteria:

* To be included, participants must be healthy, as determined by self-report and heart rate/blood pressure (HR/BP) check, between the ages of 18-25, and willing to provide informed consent.
* 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 with a self-reported history of chronic diseases or psychiatric conditions will be excluded.
* Other exclusion criteria are: history of or active cardiovascular disease, current oral health problems or injuries, low/high BP, seizures, regular prescription medication use (other than vitamins or birth control), and past month use of cocaine, opioids, benzodiazepines, and methamphetamine (self-report).
* 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.

Primary outcomes:
measure: Change in saliva nicotine concentration
timeFrame: Saliva will be collected at baseline before the first product administration, at 10 min following each product administration, and 55 min following the first product administration (baseline for the second product administration).
measure: Change in breakpoint from two behavioral choice tasks (Cigarette Purchase Task, Multiple Choice Procedure)
timeFrame: A behavioral choice task (cigarette purchase cask) will be completed at baseline before the first product administration, 5, 15, 30, and 45 min following each bout. 45 min after the second bout, the multiple choice procedure will be administered.
measure: Change in Addiction Research Center Inventory subjective abuse liability
timeFrame: Subjective measures of abuse liability will be collected at baseline before the first product administration, 5, 15, 30, and 45 min following each bout.
measure: Change in Direct Effects of Nicotine and Tobacco Scale subjective abuse liability
timeFrame: Subjective measures of abuse liability will be collected at baseline before the first product administration, 5, 15, 30, and 45 min following each bout.
measure: Change in Tobacco Abstinence Symptoms and Drug Effects subjective abuse liability
timeFrame: Subjective measures of abuse liability will be collected at baseline before the first product administration, 5, 15, 30, and 45 min following each bout.
Secondary outcomes:
measure: Expired air carbon monoxide
timeFrame: Expired air carbon monoxide measurement will occur at baseline before the first product administration, 15 minutes following each bout, 55 min following the first product administration (baseline for the second product administration).
measure: Heart rate
timeFrame: Heart rate will be recorded at one second intervals from session onset (minute zero of session) through minute 155 of the session (end of session).
measure: Blood pressure
timeFrame: Blood pressure will be recorded at 5 minute intervals from from session onset (minute zero of session) through minute 155 of the session (end of session).
measure: Puff Volume (ml)
timeFrame: Puff Volume will be measured in seconds for each puff during product administration (10 puffs with a 30-second interpuff interval directed and monitored by staff)
measure: Puff Duration (seconds)
timeFrame: Puff Duration will be measured in seconds for each puff during product administration (10 puffs with a 30-second interpuff interval directed and monitored by staff)
Other outcomes:
Locations:
city: Richmond
country: United States
facility: VCU Behavioral Health Research Laboratory
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Andrew J Barnes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.