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

March 2, 2020 updated by: Duke University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

182

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Immediately after puff administration of each study cigarette
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.
30 minutes after sampling all 3 study cigarettes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mood and Affect
Time Frame: Immediately after puff administration of each study cigarette
The Positive and Negative Affect Schedule (PANAS)
Immediately after puff administration of each study cigarette
Mood and Affect
Time Frame: Immediately after puff administration of each study cigarette
Minnesota Nicotine Withdrawal Scale (MNWS)
Immediately after puff administration of each study cigarette
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
Immediately after puff administration of each study cigarette
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
During self-administration of chosen cigarette at the last experimental session (approximately over 10 minutes)
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
During self-administration of chosen cigarette at the last experimental session (approximately over 10 minutes)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

National Institute on Drug Abuse (NIDA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

October 22, 2019

Study Completion (Actual)

December 17, 2019

Study Registration Dates

First Submitted

September 23, 2016

First Submitted That Met QC Criteria

December 8, 2016

First Posted (Estimate)

December 12, 2016

Study Record Updates

Last Update Posted (Actual)

March 4, 2020

Last Update Submitted That Met QC Criteria

March 2, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00075882
  • R01DA042532 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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