Reactions to Reduced Nicotine Cigarettes in Young Adult Low-Frequency Smokers

Nicotine Dependence Clinical Trial

— NicRed  

Official title:

Reactions to Reduced Nicotine Cigarettes in Young Adult Low-Frequency Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02989038
• Other study ID #: Pro00075882
• Secondary ID: R01DA042532
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: December 17, 2019

Study information

• Verified date: February 2020
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate reactions to, and choices to self-administer, cigarette smoke with varying nicotine content among low-frequency, non-dependent adolescent/young adult smokers between the ages of 15-25 years.

Description:

Participants will undergo three sessions in which their reactions to fixed doses of smoke from investigational cigarettes with three different nicotine contents (15.8 mg/gram of tobacco, 2.5 mg/g, and .4 mg/g) will be assessed. Following the third fixed-dose session, participants will return to the lab to choose one of the cigarettes to self-administer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: December 17, 2019
• Est. primary completion date: October 22, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 25 Years

Eligibility

Inclusion Criteria:

• generally healthy

• between the ages of 15-25

• use nicotine or tobacco products between 1-15 days/month for at least 6 months

• smokes at least 5 cigarettes/month

• no unstable or significant medical or psychiatric conditions

• breath alcohol value=0.000

• able to provide contact information for two individuals who can corroborate smoking status

Exclusion Criteria:

• use of illegal drugs as measured by urine drug screen (excluding THC)

• serious quit attempt in the past 3 months

• plans to quit smoking in the next 2 months

• current use of nicotine replacement therapy or other tobacco cessation products

• inability to attend all required experimental sessions

• blood pressure >160/100 mmHg

• pregnant, trying to become pregnant, or breastfeeding

Related Conditions & MeSH terms

• Nicotine Dependence
• Tobacco Use Disorder

Intervention

Other:
• Very Low Nicotine Content Cigarettes
cigarettes with 0.03 nicotine yield with 0.4 mg/g nicotine content and 9.0 mg tar yield
• Intermediate Nicotine Content Cigarettes
cigarettes with 0.12 nicotine yield with 2.4 mg/g nicotine content and 9.0 mg tar yield
• Normal Nicotine Content Cigarettes
cigarettes with 0.8 nicotine yield with 15.8 mg/g nicotine content and 10.5 mg tar yield

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective reactions to fixed doses of tobacco smoke	Smoking Effects Questionnaire ratings following administration of puffs for NNC, INC, and VLNC cigarettes	Immediately after puff administration of each study cigarette
Primary	Cigarette choice	Participants will choose which of the three cigarettes they prefer to smoke by ranking each of the three cigarette conditions using a 1-3 scale where 1 is the cigarette that they most desire to smoke and 3 is the cigarette that they least desire to smoke.	30 minutes after sampling all 3 study cigarettes
Secondary	Mood and Affect	The Positive and Negative Affect Schedule (PANAS)	Immediately after puff administration of each study cigarette
Secondary	Mood and Affect	Minnesota Nicotine Withdrawal Scale (MNWS)	Immediately after puff administration of each study cigarette
Secondary	Smoking topography - Change in Carbon Monoxide (CO) values (in parts per million, ppm) following puff administration	CO values (in ppm) will be obtained using a handheld CO monitor prior to puff administration and 5 minutes after completion of cigarette puff administration. The difference in values will provide a CO boost value	Immediately after puff administration of each study cigarette
Secondary	Smoking topography - number of puffs	number of puffs	During self-administration of chosen cigarette at the last experimental session (approximately over 10 minutes)
Secondary	Smoking topography - interpuff interval	Interpuff interval (in seconds) will be calculated using video recordings of self-administration of chosen cigarette	During self-administration of chosen cigarette at the last experimental session (approximately over 10 minutes)