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

Primary Purpose

Nicotine Dependence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Very Low Nicotine Content Cigarettes
Intermediate Nicotine Content Cigarettes
Normal Nicotine Content Cigarettes
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Nicotine Dependence focused on measuring smoker, young adult, adolescent

Eligibility Criteria

15 Years - 25 Years (Child, Adult)All SexesAccepts 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

Sites / Locations

  • Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

NNC, INC, VLNC

NNC, VLNC, INC

INC, VLNC, NNC

INC, NNC, VLNC

VLNC, NNC, INC

VLNC, INC, NNC

Arm Description

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

Subjective reactions to fixed doses of tobacco smoke
Smoking Effects Questionnaire ratings following administration of puffs for NNC, INC, and VLNC cigarettes
Cigarette choice
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
The Positive and Negative Affect Schedule (PANAS)
Mood and Affect
Minnesota Nicotine Withdrawal Scale (MNWS)
Smoking topography - Change in Carbon Monoxide (CO) values (in parts per million, ppm) following puff administration
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
number of puffs
Smoking topography - interpuff interval
Interpuff interval (in seconds) will be calculated using video recordings of self-administration of chosen cigarette

Full Information

First Posted
September 23, 2016
Last Updated
March 2, 2020
Sponsor
Duke University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT02989038
Brief Title
Reactions to Reduced Nicotine Cigarettes in Young Adult Low-Frequency Smokers
Acronym
NicRed
Official Title
Reactions to Reduced Nicotine Cigarettes in Young Adult Low-Frequency Smokers
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
October 22, 2019 (Actual)
Study Completion Date
December 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence
Keywords
smoker, young adult, adolescent

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
182 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NNC, INC, VLNC
Arm Type
Experimental
Arm Description
Normal Nicotine Content (NNC), Intermediate Nicotine Content (INC), Very Low Nicotine Content (VLNC)
Arm Title
NNC, VLNC, INC
Arm Type
Experimental
Arm Description
Normal Nicotine Content, Very Low Nicotine Content, Intermediate Nicotine Content
Arm Title
INC, VLNC, NNC
Arm Type
Experimental
Arm Description
Intermediate Nicotine Content, Very Low Nicotine Content, Normal Nicotine Content
Arm Title
INC, NNC, VLNC
Arm Type
Experimental
Arm Description
Intermediate Nicotine Content, Normal Nicotine Content, Very Low Nicotine Content
Arm Title
VLNC, NNC, INC
Arm Type
Experimental
Arm Description
Very Low Nicotine Content, Normal Nicotine Content, Intermediate Nicotine Content
Arm Title
VLNC, INC, NNC
Arm Type
Experimental
Arm Description
Very Low Nicotine Content, Intermediate Nicotine Content, Normal Nicotine Content
Intervention Type
Other
Intervention Name(s)
Very Low Nicotine Content Cigarettes
Other Intervention Name(s)
Tobacco, Cigarettes
Intervention Description
cigarettes with 0.03 nicotine yield with 0.4 mg/g nicotine content and 9.0 mg tar yield
Intervention Type
Other
Intervention Name(s)
Intermediate Nicotine Content Cigarettes
Other Intervention Name(s)
Tobacco, Cigarettes
Intervention Description
cigarettes with 0.12 nicotine yield with 2.4 mg/g nicotine content and 9.0 mg tar yield
Intervention Type
Other
Intervention Name(s)
Normal Nicotine Content Cigarettes
Other Intervention Name(s)
Tobacco, Cigarettes
Intervention Description
cigarettes with 0.8 nicotine yield with 15.8 mg/g nicotine content and 10.5 mg tar yield
Primary Outcome Measure Information:
Title
Subjective reactions to fixed doses of tobacco smoke
Description
Smoking Effects Questionnaire ratings following administration of puffs for NNC, INC, and VLNC cigarettes
Time Frame
Immediately after puff administration of each study cigarette
Title
Cigarette choice
Description
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.
Time Frame
30 minutes after sampling all 3 study cigarettes
Secondary Outcome Measure Information:
Title
Mood and Affect
Description
The Positive and Negative Affect Schedule (PANAS)
Time Frame
Immediately after puff administration of each study cigarette
Title
Mood and Affect
Description
Minnesota Nicotine Withdrawal Scale (MNWS)
Time Frame
Immediately after puff administration of each study cigarette
Title
Smoking topography - Change in Carbon Monoxide (CO) values (in parts per million, ppm) following puff administration
Description
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
Time Frame
Immediately after puff administration of each study cigarette
Title
Smoking topography - number of puffs
Description
number of puffs
Time Frame
During self-administration of chosen cigarette at the last experimental session (approximately over 10 minutes)
Title
Smoking topography - interpuff interval
Description
Interpuff interval (in seconds) will be calculated using video recordings of self-administration of chosen cigarette
Time Frame
During self-administration of chosen cigarette at the last experimental session (approximately over 10 minutes)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francis J McClernon, Ph.D.
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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