Cigarette SmokingNCT02301325
Project 1, Study 2: The Combined Impact of Nicotine Replacement and Spectrum Cigarettes
A study testing Smoking research cigarettes with or without NRT in people with Cigarette Smoking, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
Project 1, Study 2 will evaluate the impact of very low nicotine content cigarettes with and without transdermal nicotine on cigarettes smoked per day, nicotine exposure, discomfort/dysfunction, other health-related behaviors, nicotine/tobacco dependence, biomarkers of tobacco exposure, intention to quit, compensatory… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cigarette Smoking
- What is being tested?
- Smoking research cigarettes with or without NRT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Apr 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18+
- Smoke an average of at least five cigarettes per day for the last year with no periods of continuous abstinence longer than 30 days.
- Breath CO levels > or = 10 ppm (if < 10 ppm, then NicAlert Strip = 6)
- Fulfills need for participants in the required strata (menthol status)
Who cannot join
- Intention to quit smoking in the next 30 days
- Currently seeking treatment for smoking cessation
- Currently using nicotine replacement therapies or other pharmacotherapies as cessation aid (intermittent use acceptable)
- Significant prior adverse reaction to nicotine replacement as determined by the licensed medical professional.
- A quit attempt in the past 30 days resulting in greater than 3 days of abstinence
- Using other tobacco products more than 9 days in the past 30 days
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- Significant unstable medical conditions (any significant change in a serious medical condition occurring during the past 3 months including cardiovascular disease, COPD, and cancer, as determined by the licensed medical professional)
- Significant unstable psychiatric conditions (any significant change in psychiatric symptoms during the past 3 months as determined by the licensed medical professional)
- Schizophrenia and schizoaffective disorder
- Positive toxicology screen for any of the following drugs: marijuana, cocaine, opiates, methadone, benzodiazepines, barbiturates, amphetamines, methamphetamines, and PCP
- Participants with valid prescriptions for any toxicology results will not be excluded.
- Breath alcohol level > 0.01
- Binge drinking alcohol (more than 9 days in the past 30 days, 4/5 drinks in a 2 hour period (female/male))
- Pregnant, trying to become pregnant or breastfeeding
- Smoking 'roll your own cigarettes' exclusively
- Currently taking any one of the following medications:
- Phenytoin [Brand Name: Dilantin]
- Carbamazepine [Brand Name: Tegretol, Carbatrol, Equetro, Epitol]
- Oxcarbazepine [Brand Name: Trileptal]
- Primidone [Brand Name: Mysoline]
- Phenobarbital
- Bendamustine [Brand Name: Treanda]
- Clopidogrel [Brand Name: Plavix]
- Clozapine [Brand Name: Clozaril, FazaClo]
- Erlotinib [Brand Name: Tarceva]
- Flecainide [Brand Name: Tambocor]
- Fluvoxamine [Brand Name: Luvox]
- Irinotecan [Brand Name: Camptosar]
- Olanzapine [Brand Name: Zyprexa]
- Ropinirole [Brand Name: Requip]
- Tacrine [Brand Name: Cognex]
- Theophylline [Brand Name: Theo Dur]
- Estradiol
- CO reading >80 ppm
- Systolic BP greater than or equal to 160
- Participants failing for blood pressure will be allowed to re-screen once.
- Diastolic BP greater than or equal to 100
- Participants failing for blood pressure will be allowed to re-screen once.
- Systolic BP below 90
- Participants failing for blood pressure will be allowed to re-screen once.
- Diastolic BP below 50
- Participants failing for blood pressure will be allowed to re-screen once.
- Heart rate greater than or equal to 105 bpm
- Participants failing for heart rate will be allowed to re-screen once.
- Heart rate lower than 45 bpm
- Participants failing for heart rate will be allowed to re-screen once.
- Indicating any suicidal ideation in the past month or suicide attempts in the past 5 years (if within the past 6-10 years, LMP approval required).
- Inability to independently read and comprehend the consent form and other written study materials and measures.
- Having participated in a research study during the past three months in which the participant:
- Smoked a cigarette that was not his/her usual brand cigarette for more than one day
- Used any tobacco products beyond normal use for more than one day
- Used any nicotine replacement products or smoking cessation medications for more than one day
- Having participated in Project 1, Study 1 (PRO11060292)
- Having participated in Project 1, Study 1C (PRO14040384)
- Household member enrolled in the study concurrently
- Significant prior adverse reactions to adhesives or latex
- Participant has a condition that interferes/does not allow for the collection of eligibility criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
About this study
Project 1, Study 2 will evaluate the impact of very low nicotine content cigarettes with and without transdermal nicotine on cigarettes smoked per day, nicotine exposure, discomfort/dysfunction, other health-related behaviors, nicotine/tobacco dependence, biomarkers of tobacco exposure, intention to quit, compensatory smoking, other tobacco use, cigarette characteristics, cue reactivity, cardiovascular function, perceived risk and cue reactivity. The investigators will also consider differences between conditions in compliance with product use and the ability to abstain from smoking when provided a financial incentive for abstinence.
- Conditions
- Cigarette Smoking
- Being tested
- Smoking research cigarettes with or without NRT
- Medical subject headings
- Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking research cigarettes with or without NRTBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 0.03 mg Nicotine Cigarette | Other | Participants will be assigned to smoke 0.03 mg nicotine Spectrum cigarettes Receives: Behavioral: Smoking research cigarettes with or without NRT |
| 0.03 mg Nicotine Cigarette and NRT | Other | Participants will be assigned to smoke 0.03 mg nicotine Spectrum cigarettes and use nicotine replacement patches. Receives: Behavioral: Smoking research cigarettes with or without NRT |
| 0.80 mg Nicotine Cigarette | Other | Participants will be assigned to smoke 0.80 mg nicotine Spectrum cigarettes. Receives: Behavioral: Smoking research cigarettes with or without NRT |
| 0.80 mg Nicotine Cigarette and NRT | Other | Participants will be assigned to smoke 0.80 mg nicotine Spectrum cigarettes and use nicotine replacement patches. Receives: Behavioral: Smoking research cigarettes with or without NRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cigarettes Smoked Per Day
Measured: Six Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cigarette SmokingStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Eric Donny, Ph.D., Principal investigator, Professor, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02301325
- Sponsor's protocol ID
- U54 DA031659-P1S2
- Other IDs
- 1U54DA031659-01
- Status last verified
- Aug 2018
- First submitted
- 21 Nov 2014
- Last updated
- 15 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Smith TT, Koopmeiners JS, Tessier KM, Davis EM, Conklin CA, Denlinger-Apte RL, Lane T, Murphy SE, Tidey JW, Hatsukami DK, Donny EC. Randomized Trial of Low-Nicotine Cigarettes and Transdermal Nicotine. Am J Prev Med. 2019 Oct;57(4):515-524. doi: 10.1016/j.amepre.2019.05.010.
PubMed 31542129
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project 1, Study 2: The Combined Impact of Nicotine Replacement and Spectrum Cigarettes
- ClinicalTrials.gov ID
- NCT02301325
- Acronym / sponsor ID
- U54 DA031659-P1S2
- Conditions
- Cigarette Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Nov 2014
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 25 Nov 2014 (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.
Project 1, Study 2 will evaluate the impact of very low nicotine content cigarettes with and without transdermal nicotine on cigarettes smoked per day, nicotine exposure, discomfort/dysfunction, other health-related behaviors, nicotine/tobacco dependence, biomarkers of tobacco exposure, intention to quit, compensatory smoking, other tobacco use, cigarette characteristics, cue reactivity, cardiovascular function, perceived risk and cue reactivity. The investigators will also consider differences between conditions in compliance with product use and the ability to abstain from smoking when provided a financial incentive for abstinence.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 0.03 mg Nicotine Cigarette | Other | Behavioral: Smoking research cigarettes with or without NRTParticipants will be assigned to smoke 0.03 mg nicotine Spectrum cigarettes |
| 0.03 mg Nicotine Cigarette and NRT | Other | Behavioral: Smoking research cigarettes with or without NRTParticipants will be assigned to smoke 0.03 mg nicotine Spectrum cigarettes and use nicotine replacement patches. |
| 0.80 mg Nicotine Cigarette | Other | Behavioral: Smoking research cigarettes with or without NRTParticipants will be assigned to smoke 0.80 mg nicotine Spectrum cigarettes. |
| 0.80 mg Nicotine Cigarette and NRT | Other | Behavioral: Smoking research cigarettes with or without NRTParticipants will be assigned to smoke 0.80 mg nicotine Spectrum cigarettes and use nicotine replacement patches. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18+
- Smoke an average of at least five cigarettes per day for the last year with no periods of continuous abstinence longer than 30 days.
- Breath CO levels > or = 10 ppm (if < 10 ppm, then NicAlert Strip = 6)
- Fulfills need for participants in the required strata (menthol status)
Key exclusion criteria (57 listed)
- Intention to quit smoking in the next 30 days
- Currently seeking treatment for smoking cessation
- Currently using nicotine replacement therapies or other pharmacotherapies as cessation aid (intermittent use acceptable)
- Significant prior adverse reaction to nicotine replacement as determined by the licensed medical professional.
- A quit attempt in the past 30 days resulting in greater than 3 days of abstinence
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 |
|---|---|---|
| Smoking research cigarettes with or without NRT | Behavioural | 0.03 mg Nicotine Cigarette, 0.03 mg Nicotine Cigarette and NRT, 0.80 mg Nicotine Cigarette, 0.80 mg Nicotine Cigarette and NRT |
Primary outcome
Cigarettes Smoked Per Day
Time frame: Six Weeks
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 15 Aug 2018.
- Derived from this study: PubMed 31542129Smith TT, Koopmeiners JS, Tessier KM, Davis EM, Conklin CA, Denlinger-Apte RL, Lane T, Murphy SE, Tidey JW, Hatsukami DK, Donny EC. Randomized Trial of Low-Nicotine Cigarettes and Transdermal Nicotine. Am J Prev Med. 2019 Oct;57(4):515-524. doi: 10.1016/j.amepre.2019.05.010.
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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.
Eric Donny, Ph.D. principal investigator
Professor, University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smoking research cigarettes with or without NRT in people with Cigarette Smoking, run by Wake Forest University Health Sciences at 1 site in United States.
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 4 inclusion and 57 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 15 Aug 2018. 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?
Cigarettes Smoked Per Day (time frame: Six Weeks). 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 NCT02301325, which also lists 1 linked publication.
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 15 Aug 2018.