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

NCT02937051 | Completed

• 2 other identifiers: HM20007848R03DA043005
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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. 1.own-brand CTC (positive control),
2. 2.original-flavored Black \& Mild (B\&M) cigar,
3. 3.apple-flavored B\&M cigar,
4. 4.cream-flavored B\&M cigar, and
5. 5.wine-flavored B\&M cigar.

Conditions

Tobacco Products

Outcome Measures

Primary Outcomes (5)

• Change in saliva nicotine concentration

  Each participant will attend 5 study sessions, each study session will include two bouts of product administration. Product administration will consist of 10 puffs with a 30-second interpuff interval (IPI; puff number and IPI will be directed and monitored by staff).

  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).

• Change in breakpoint from two behavioral choice tasks (Cigarette Purchase Task, Multiple Choice Procedure)

  Each participant will attend 5 study sessions, each study session will include two bouts of product administration. Product administration will consist of 10 puffs with a 30-second interpuff interval (IPI; puff number and IPI will be directed and monitored by staff).

  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.

• Change in Addiction Research Center Inventory subjective abuse liability

  Each participant will attend 5 study sessions, each study session will include two bouts of product administration. Product administration will consist of 10 puffs with a 30-second interpuff interval (IPI; puff number and IPI will be directed and monitored by staff).

  Subjective measures of abuse liability will be collected at baseline before the first product administration, 5, 15, 30, and 45 min following each bout.

• Change in Direct Effects of Nicotine and Tobacco Scale subjective abuse liability

  Each participant will attend 5 study sessions, each study session will include two bouts of product administration. Product administration will consist of 10 puffs with a 30-second interpuff interval (IPI; puff number and IPI will be directed and monitored by staff).

  Subjective measures of abuse liability will be collected at baseline before the first product administration, 5, 15, 30, and 45 min following each bout.

• Change in Tobacco Abstinence Symptoms and Drug Effects subjective abuse liability

  Each participant will attend 5 study sessions, each study session will include two bouts of product administration. Product administration will consist of 10 puffs with a 30-second interpuff interval (IPI; puff number and IPI will be directed and monitored by staff).

  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 (5)

• Expired air carbon monoxide

  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).

• Heart rate

  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).

• Blood pressure

  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).

• Puff Volume (ml)

  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)

• Puff Duration (seconds)

  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)

Study Arms (5)

Own Brand Cigarette Condition

ACTIVE COMPARATOR

Other: Tobacco product administration and assessment

Original-flavor Black&Mild cigar

EXPERIMENTAL

Other: Tobacco product administration and assessment

Apple-flavor Black&Mild cigar

EXPERIMENTAL

Other: Tobacco product administration and assessment

Cream-flavor Black&Mild cigar

EXPERIMENTAL

Other: Tobacco product administration and assessment

Wine-flavor Black&Mild cigar

EXPERIMENTAL

Other: Tobacco product administration and assessment

Interventions

Tobacco product administration and assessment OTHER

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; Cream-flavor Black&Mild cigar; Original-flavor Black&Mild cigar; Own Brand Cigarette Condition; Wine-flavor Black&Mild cigar

Eligibility Criteria

• Age: 18 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• Individuals with a self-reported history of chronic diseases or psychiatric conditions will be excluded.
• 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.

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

VCU Behavioral Health Research Laboratory

Richmond, Virginia, 23284, United States

Location

Related Publications (1)

• 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.

  PMID: 30309993 DERIVED

MeSH Terms

Interventions

Restraint, Physical

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Officials

• Andrew J Barnes, PhD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2016
• First Posted: October 18, 2016
• Study Start: October 1, 2016
• Primary Completion: April 12, 2019
• Study Completion: April 12, 2019
• Last Updated: April 23, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)