Nicotine DependenceNicRedNCT02989038

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

A study testing Very Low Nicotine Content Cigarettes, Intermediate Nicotine Content Cigarettes and Normal Nicotine Content Cigarettes in people with Nicotine Dependence, run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 15 to 25 yearsHealthy volunteers can take part
Conditions the study is for: Nicotine Dependence
What is being tested?: Very Low Nicotine Content Cigarettes, Intermediate Nicotine Content Cigarettes and Normal Nicotine Content Cigarettes
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 182 participants
Where: 1 siteUnited States
Study dates: Jan 2017to 17 Dec 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 15 to 25 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Duke University Medical Center
Durham, North Carolina, 27705

Other trials in United States

About this study

Read the 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.

Conditions: Nicotine Dependence
Being tested: Very Low Nicotine Content Cigarettes, Intermediate Nicotine Content Cigarettes, Normal Nicotine Content Cigarettes
Keywords: smoker, young adult, adolescent
Medical subject headings: Tobacco Use Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Very Low Nicotine Content CigarettesOther
Also called Tobacco, Cigarettes
cigarettes with 0.03 nicotine yield with 0.4 mg/g nicotine content and 9.0 mg tar yield
Intermediate Nicotine Content CigarettesOther
Also called Tobacco, Cigarettes
cigarettes with 0.12 nicotine yield with 2.4 mg/g nicotine content and 9.0 mg tar yield
Normal Nicotine Content CigarettesOther
Also called Tobacco, Cigarettes
cigarettes with 0.8 nicotine yield with 15.8 mg/g nicotine content and 10.5 mg tar yield

Study groups in NCT02989038
Study group	Role	What they receive
NNC, INC, VLNC	Experimental	Normal Nicotine Content (NNC), Intermediate Nicotine Content (INC), Very Low Nicotine Content (VLNC) Receives: Other: Very Low Nicotine Content Cigarettes; Other: Intermediate Nicotine Content Cigarettes; Other: Normal Nicotine Content Cigarettes
NNC, VLNC, INC	Experimental	Normal Nicotine Content, Very Low Nicotine Content, Intermediate Nicotine Content Receives: Other: Very Low Nicotine Content Cigarettes; Other: Intermediate Nicotine Content Cigarettes; Other: Normal Nicotine Content Cigarettes
INC, VLNC, NNC	Experimental	Intermediate Nicotine Content, Very Low Nicotine Content, Normal Nicotine Content Receives: Other: Very Low Nicotine Content Cigarettes; Other: Intermediate Nicotine Content Cigarettes; Other: Normal Nicotine Content Cigarettes
INC, NNC, VLNC	Experimental	Intermediate Nicotine Content, Normal Nicotine Content, Very Low Nicotine Content Receives: Other: Very Low Nicotine Content Cigarettes; Other: Intermediate Nicotine Content Cigarettes; Other: Normal Nicotine Content Cigarettes
VLNC, NNC, INC	Experimental	Very Low Nicotine Content, Normal Nicotine Content, Intermediate Nicotine Content Receives: Other: Very Low Nicotine Content Cigarettes; Other: Intermediate Nicotine Content Cigarettes; Other: Normal Nicotine Content Cigarettes
VLNC, INC, NNC	Experimental	Very Low Nicotine Content, Intermediate Nicotine Content, Normal Nicotine Content Receives: Other: Very Low Nicotine Content Cigarettes; Other: Intermediate Nicotine Content Cigarettes; Other: Normal Nicotine Content Cigarettes

What is being measured

The primary outcome is the main question the study is designed to answer.

Subjective reactions to fixed doses of tobacco smoke
Smoking Effects Questionnaire ratings following administration of puffs for NNC, INC, and VLNC cigarettes
Measured: Immediately after puff administration of each study cigarette
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.
Measured: 30 minutes after sampling all 3 study cigarettes

Secondary outcomes (5)

Mood and Affect
The Positive and Negative Affect Schedule (PANAS)
Measured: Immediately after puff administration of each study cigarette
Mood and Affect
Minnesota Nicotine Withdrawal Scale (MNWS)
Measured: Immediately after puff administration of each study cigarette
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
Measured: Immediately after puff administration of each study cigarette
Smoking topography - number of puffs
number of puffs
Measured: During self-administration of chosen cigarette at the last experimental session (approximately over 10 minutes)
Smoking topography - interpuff interval
Interpuff interval (in seconds) will be calculated using video recordings of self-administration of chosen cigarette
Measured: During self-administration of chosen cigarette at the last experimental session (approximately over 10 minutes)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 201717 Dec 2019

First posted12 Dec 2016 (estimated)
Study startJan 2017
Primary completion22 Oct 2019
Study completion17 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Nicotine DependenceStudies of the same condition, open and under way.
More trials run by Duke UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 182 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02989038
Sponsor's protocol ID: Pro00075882
Other IDs: R01DA042532
Acronym: NicRed
Status last verified: Feb 2020
First submitted: 23 Sep 2016
Last updated: 4 Mar 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Nicotine Dependence trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Reactions to Reduced Nicotine Cigarettes in Young Adult Low-Frequency Smokers
ClinicalTrials.gov ID: NCT02989038
Acronym / sponsor ID: NicRed / Pro00075882
Conditions: Nicotine Dependence
Keywords: smoker, young adult, adolescent
Study type: Interventional
Recruitment status: Completed
Enrolment: 182 participants (actual)
Lead sponsor: Duke UniversityUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: Jan 2017 (actual)
Primary completion: 22 Oct 2019 (actual)
Study completion: 17 Dec 2019 (actual)
First posted: 12 Dec 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 6

Arm	Type	Receives
NNC, INC, VLNC	Experimental	Other: Very Low Nicotine Content Cigarettes, Other: Intermediate Nicotine Content Cigarettes, Other: Normal Nicotine Content CigarettesNormal Nicotine Content (NNC), Intermediate Nicotine Content (INC), Very Low Nicotine Content (VLNC)
NNC, VLNC, INC	Experimental	Other: Very Low Nicotine Content Cigarettes, Other: Intermediate Nicotine Content Cigarettes, Other: Normal Nicotine Content CigarettesNormal Nicotine Content, Very Low Nicotine Content, Intermediate Nicotine Content
INC, VLNC, NNC	Experimental	Other: Very Low Nicotine Content Cigarettes, Other: Intermediate Nicotine Content Cigarettes, Other: Normal Nicotine Content CigarettesIntermediate Nicotine Content, Very Low Nicotine Content, Normal Nicotine Content
INC, NNC, VLNC	Experimental	Other: Very Low Nicotine Content Cigarettes, Other: Intermediate Nicotine Content Cigarettes, Other: Normal Nicotine Content CigarettesIntermediate Nicotine Content, Normal Nicotine Content, Very Low Nicotine Content
VLNC, NNC, INC	Experimental	Other: Very Low Nicotine Content Cigarettes, Other: Intermediate Nicotine Content Cigarettes, Other: Normal Nicotine Content CigarettesVery Low Nicotine Content, Normal Nicotine Content, Intermediate Nicotine Content
VLNC, INC, NNC	Experimental	Other: Very Low Nicotine Content Cigarettes, Other: Intermediate Nicotine Content Cigarettes, Other: Normal Nicotine Content CigarettesVery Low Nicotine Content, Intermediate Nicotine Content, Normal Nicotine Content

Who may qualify

Ages: 15 to 25 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Very Low Nicotine Content CigarettesAlso: Tobacco, Cigarettescigarettes with 0.03 nicotine yield with 0.4 mg/g nicotine content and 9.0 mg tar yield	Other	INC, NNC, VLNC, INC, VLNC, NNC, NNC, INC, VLNC, NNC, VLNC, INC, VLNC, INC, NNC, VLNC, NNC, INC
Intermediate Nicotine Content CigarettesAlso: Tobacco, Cigarettescigarettes with 0.12 nicotine yield with 2.4 mg/g nicotine content and 9.0 mg tar yield	Other	INC, NNC, VLNC, INC, VLNC, NNC, NNC, INC, VLNC, NNC, VLNC, INC, VLNC, INC, NNC, VLNC, NNC, INC
Normal Nicotine Content CigarettesAlso: Tobacco, Cigarettescigarettes with 0.8 nicotine yield with 15.8 mg/g nicotine content and 10.5 mg tar yield	Other	INC, NNC, VLNC, INC, VLNC, NNC, NNC, INC, VLNC, NNC, VLNC, INC, VLNC, INC, NNC, VLNC, NNC, INC

Primary outcome

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.

5 secondary outcomes

Mood and Affect
Time frame: Immediately after puff administration of each study cigarette
Mood and Affect
Time frame: 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
Smoking topography - number of puffs
Time frame: 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)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
Individual participant dataSharing planned: No

Related trials for Nicotine Dependence

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Tobacco Use Disorder, Nicotine Dependence
Recruiting
Social Media Support Groups for Adolescent Vaping Cessation
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Recruiting
The INITIATE Study: Initiating Nicotine Dependence Treatment for Smokers Admitted to Emergency Departments
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Francis J McClernon, Ph.D. principal investigator

Duke University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subjective reactions to fixed doses of tobacco smoke (time frame: Immediately after puff administration of each study cigarette). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02989038.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2020.