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

Tobacco Products Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02937051
• Other study ID #: HM20007848
• Secondary ID: R03DA043005
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: April 12, 2019

Study information

• Verified date: April 2019
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: April 12, 2019
• Est. primary completion date: April 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 21 Years

Eligibility

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.

Related Conditions & MeSH terms

• Tobacco Products

Intervention

Other:
• 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

Locations

Country	Name	City	State
United States	VCU Behavioral Health Research Laboratory	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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.
Primary	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.
Primary	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.
Primary	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	Expired air carbon monoxide	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).	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).
Secondary	Heart rate	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).	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).
Secondary	Blood pressure	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).	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).
Secondary	Puff Volume (ml)	The instrument senses flow-induced pressure drop across an orifice that is incorporated into the mouthpiece. Each participant will attend 5 study sessions, each study session will include two bouts of product administration. Puff Volume and Puff Duration will be used to calculate measures of Puff Flow Rate (Puff Volume/Puff Duration) and Total Puff Volume (Puff Volume per puff x 10 puffs).	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)
Secondary	Puff Duration (seconds)	The instrument senses flow-induced pressure drop across an orifice that is incorporated into the mouthpiece. Each participant will attend 5 study sessions, each study session will include two bouts of product administration. Puff Volume and Puff Duration will be used to calculate measures of Puff Flow Rate (Puff Volume/Puff Duration) and Total Puff Volume (Puff Volume per puff x 10 puffs).	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)