Effects of Cigar Flavors on Measures of Abuse Liability Among Young Adults

Virginia Commonwealth University (VCU)

Status: Completed

Conditions: Tobacco Products

Treatments: Other: Tobacco product administration and assessment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02937051

HM20007848

R03DA043005 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 21 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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25 participants in 5 patient groups

Own Brand Cigarette Condition

Active Comparator group

Treatment:

Other: Tobacco product administration and assessment

Original-flavor Black&Mild cigar

Experimental group

Treatment:

Other: Tobacco product administration and assessment

Apple-flavor Black&Mild cigar

Experimental group

Treatment:

Other: Tobacco product administration and assessment

Cream-flavor Black&Mild cigar

Experimental group

Treatment:

Other: Tobacco product administration and assessment

Wine-flavor Black&Mild cigar

Experimental group

Treatment:

Other: Tobacco product administration and assessment