We are updating the design of this site. Learn more.
Show more
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)

This study is currently recruiting participants.
Verified June 2017 by Duke University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02989038
First Posted: December 12, 2016
Last Update Posted: July 26, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Duke University
  Purpose
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 18-25 years.

Condition Intervention
Nicotine Dependence Other: Very Low Nicotine Content Cigarettes Other: Intermediate Nicotine Content Cigarettes Other: Normal Nicotine Content Cigarettes

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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

  • 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:
  • Mood and Affect [ Time Frame: Immediately after puff administration of each study cigarette ]
    The Positive and Negative Affect Schedule (PANAS)

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

  • 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

  • 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

  • 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


Estimated Enrollment: 90
Actual Study Start Date: January 2017
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: April 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

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.


Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • generally healthy
  • between the ages of 18-25
  • use nicotine or tobacco products between 1-15 days/month for at least 6 months
  • smokes at least 10 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
  Contacts and Locations
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


Contacts
Contact: Rachel Kozink, M.S. 919-668-2963 rachel.kozink@duke.edu

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27705
Contact: Rachel Kozink       rachel.kozink@duke.edu   
Sponsors and Collaborators
Duke University
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Francis J McClernon, Ph.D. Duke University
  More Information

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02989038     History of Changes
Other Study ID Numbers: Pro00075882
R01DA042532 ( U.S. NIH Grant/Contract )
First Submitted: September 23, 2016
First Posted: December 12, 2016
Last Update Posted: July 26, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant 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