Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT02989038
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02989038
Recruitment Status : Completed
First Posted : December 12, 2016
Last Update Posted : March 4, 2020
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Duke University

Brief 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.

Condition or disease Intervention/treatment Phase
Nicotine Dependence Other: Very Low Nicotine Content Cigarettes Other: Intermediate Nicotine Content Cigarettes Other: Normal Nicotine Content Cigarettes Not Applicable

Detailed 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 182 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Reactions to Reduced Nicotine Cigarettes in Young Adult Low-Frequency Smokers
Actual Study Start Date : January 2017
Actual Primary Completion Date : October 22, 2019
Actual Study Completion Date : December 17, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: NNC, INC, VLNC
Normal Nicotine Content (NNC), Intermediate Nicotine Content (INC), Very Low Nicotine Content (VLNC)
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
Other Names:
  • Tobacco
  • Cigarettes

Other: Intermediate Nicotine Content Cigarettes
cigarettes with 0.12 nicotine yield with 2.4 mg/g nicotine content and 9.0 mg tar yield
Other Names:
  • Tobacco
  • Cigarettes

Other: Normal Nicotine Content Cigarettes
cigarettes with 0.8 nicotine yield with 15.8 mg/g nicotine content and 10.5 mg tar yield
Other Names:
  • Tobacco
  • Cigarettes

Experimental: NNC, VLNC, INC
Normal Nicotine Content, Very Low Nicotine Content, Intermediate Nicotine Content
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
Other Names:
  • Tobacco
  • Cigarettes

Other: Intermediate Nicotine Content Cigarettes
cigarettes with 0.12 nicotine yield with 2.4 mg/g nicotine content and 9.0 mg tar yield
Other Names:
  • Tobacco
  • Cigarettes

Other: Normal Nicotine Content Cigarettes
cigarettes with 0.8 nicotine yield with 15.8 mg/g nicotine content and 10.5 mg tar yield
Other Names:
  • Tobacco
  • Cigarettes

Experimental: INC, VLNC, NNC
Intermediate Nicotine Content, Very Low Nicotine Content, Normal Nicotine Content
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
Other Names:
  • Tobacco
  • Cigarettes

Other: Intermediate Nicotine Content Cigarettes
cigarettes with 0.12 nicotine yield with 2.4 mg/g nicotine content and 9.0 mg tar yield
Other Names:
  • Tobacco
  • Cigarettes

Other: Normal Nicotine Content Cigarettes
cigarettes with 0.8 nicotine yield with 15.8 mg/g nicotine content and 10.5 mg tar yield
Other Names:
  • Tobacco
  • Cigarettes

Experimental: INC, NNC, VLNC
Intermediate Nicotine Content, Normal Nicotine Content, Very Low Nicotine Content
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
Other Names:
  • Tobacco
  • Cigarettes

Other: Intermediate Nicotine Content Cigarettes
cigarettes with 0.12 nicotine yield with 2.4 mg/g nicotine content and 9.0 mg tar yield
Other Names:
  • Tobacco
  • Cigarettes

Other: Normal Nicotine Content Cigarettes
cigarettes with 0.8 nicotine yield with 15.8 mg/g nicotine content and 10.5 mg tar yield
Other Names:
  • Tobacco
  • Cigarettes

Experimental: VLNC, NNC, INC
Very Low Nicotine Content, Normal Nicotine Content, Intermediate Nicotine Content
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
Other Names:
  • Tobacco
  • Cigarettes

Other: Intermediate Nicotine Content Cigarettes
cigarettes with 0.12 nicotine yield with 2.4 mg/g nicotine content and 9.0 mg tar yield
Other Names:
  • Tobacco
  • Cigarettes

Other: Normal Nicotine Content Cigarettes
cigarettes with 0.8 nicotine yield with 15.8 mg/g nicotine content and 10.5 mg tar yield
Other Names:
  • Tobacco
  • Cigarettes

Experimental: VLNC, INC, NNC
Very Low Nicotine Content, Intermediate Nicotine Content, Normal Nicotine Content
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
Other Names:
  • Tobacco
  • Cigarettes

Other: Intermediate Nicotine Content Cigarettes
cigarettes with 0.12 nicotine yield with 2.4 mg/g nicotine content and 9.0 mg tar yield
Other Names:
  • Tobacco
  • Cigarettes

Other: Normal Nicotine Content Cigarettes
cigarettes with 0.8 nicotine yield with 15.8 mg/g nicotine content and 10.5 mg tar yield
Other Names:
  • Tobacco
  • Cigarettes




Primary Outcome Measures :
  1. Subjective reactions to fixed doses of tobacco smoke [ Time Frame: Immediately after puff administration of each study cigarette ]
    Smoking Effects Questionnaire ratings following administration of puffs for NNC, INC, and VLNC cigarettes

  2. Cigarette choice [ Time Frame: 30 minutes after sampling all 3 study cigarettes ]
    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.


Secondary Outcome Measures :
  1. Mood and Affect [ Time Frame: Immediately after puff administration of each study cigarette ]
    The Positive and Negative Affect Schedule (PANAS)

  2. Mood and Affect [ Time Frame: Immediately after puff administration of each study cigarette ]
    Minnesota Nicotine Withdrawal Scale (MNWS)

  3. Smoking topography - Change in Carbon Monoxide (CO) values (in parts per million, ppm) following puff administration [ Time Frame: Immediately after puff administration of each study cigarette ]
    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

  4. Smoking topography - number of puffs [ Time Frame: During self-administration of chosen cigarette at the last experimental session (approximately over 10 minutes) ]
    number of puffs

  5. Smoking topography - interpuff interval [ Time Frame: During self-administration of chosen cigarette at the last experimental session (approximately over 10 minutes) ]
    Interpuff interval (in seconds) will be calculated using video recordings of self-administration of chosen cigarette



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   15 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02989038


Locations
Layout table for location information
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
National Institute on Drug Abuse (NIDA)
Investigators
Layout table for investigator information
Principal Investigator: Francis J McClernon, Ph.D. Duke University
Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02989038    
Other Study ID Numbers: Pro00075882
R01DA042532 ( U.S. NIH Grant/Contract )
First Posted: December 12, 2016    Key Record Dates
Last Update Posted: March 4, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Duke University:
smoker
young adult
adolescent
Additional relevant MeSH terms:
Layout table for MeSH terms
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action