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OpenTrials
Completed

NCT Number: NCT02989038

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

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.

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Key information

Conditions

Nicotine Dependence Chemically-Induced Disorders Mental Disorders Substance-Related Disorders Tobacco Use Disorder

Age range

15 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27705, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Very low nicotine content cigarettes

Other

cigarettes with 0.03 nicotine yield with 0.4 mg/g nicotine content and 9.0 mg tar yield

Other names: Tobacco, Cigarettes

Intermediate Nicotine Content Cigarettes

Other

cigarettes with 0.12 nicotine yield with 2.4 mg/g nicotine content and 9.0 mg tar yield

Other names: Tobacco, Cigarettes

Normal Nicotine Content Cigarettes

Other

cigarettes with 0.8 nicotine yield with 15.8 mg/g nicotine content and 10.5 mg tar yield

Other names: Tobacco, Cigarettes

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Acronym: NicRed

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 12, 2016
Registry last updated
Mar 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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