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

Duke University

Status: Completed

Conditions: Nicotine Dependence

Treatments: Other: Normal Nicotine Content Cigarettes; Other: Very Low Nicotine Content Cigarettes; Other: Intermediate Nicotine Content Cigarettes

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02989038

R01DA042532 (U.S. NIH Grant/Contract)

Pro00075882

Details and patient eligibility

About

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.

Full 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.

Enrollment: 182 patients

Sex: All

Ages: 15 to 25 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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182 participants in 6 patient groups

NNC, INC, VLNC

Experimental group

Description:

Normal Nicotine Content (NNC), Intermediate Nicotine Content (INC), Very Low Nicotine Content (VLNC)

Treatment:

Other: Intermediate Nicotine Content Cigarettes

Other: Very Low Nicotine Content Cigarettes

Other: Normal Nicotine Content Cigarettes

NNC, VLNC, INC

Experimental group

Description:

Normal Nicotine Content, Very Low Nicotine Content, Intermediate Nicotine Content

Treatment:

Other: Intermediate Nicotine Content Cigarettes

Other: Very Low Nicotine Content Cigarettes

Other: Normal Nicotine Content Cigarettes

INC, VLNC, NNC

Experimental group

Description:

Intermediate Nicotine Content, Very Low Nicotine Content, Normal Nicotine Content

Treatment:

Other: Intermediate Nicotine Content Cigarettes

Other: Very Low Nicotine Content Cigarettes

Other: Normal Nicotine Content Cigarettes

INC, NNC, VLNC

Experimental group

Description:

Intermediate Nicotine Content, Normal Nicotine Content, Very Low Nicotine Content

Treatment:

Other: Intermediate Nicotine Content Cigarettes

Other: Very Low Nicotine Content Cigarettes

Other: Normal Nicotine Content Cigarettes

VLNC, NNC, INC

Experimental group

Description:

Very Low Nicotine Content, Normal Nicotine Content, Intermediate Nicotine Content

Treatment:

Other: Intermediate Nicotine Content Cigarettes

Other: Very Low Nicotine Content Cigarettes

Other: Normal Nicotine Content Cigarettes

VLNC, INC, NNC

Experimental group

Description:

Very Low Nicotine Content, Intermediate Nicotine Content, Normal Nicotine Content

Treatment:

Other: Intermediate Nicotine Content Cigarettes

Other: Very Low Nicotine Content Cigarettes

Other: Normal Nicotine Content Cigarettes