Clinical trial NCT02301325: Project 1, Study 2: The Combined Impact of Nicotine Replacement and Spectrum Cigarettes
Official title: Project 1, Study 2: The Combined Impact of Nicotine Replacement and Spectrum Cigarettes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cigarette Smoking
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2014-11-25
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

1. Age 18+
2. Smoke an average of at least five cigarettes per day for the last year with no periods of continuous abstinence longer than 30 days.
3. Breath CO levels \> or = 10 ppm (if \< 10 ppm, then NicAlert Strip = 6)
4. Fulfills need for participants in the required strata (menthol status)

Exclusion Criteria:

1. Intention to quit smoking in the next 30 days
2. Currently seeking treatment for smoking cessation
3. Currently using nicotine replacement therapies or other pharmacotherapies as cessation aid (intermittent use acceptable)
4. Significant prior adverse reaction to nicotine replacement as determined by the licensed medical professional.
5. A quit attempt in the past 30 days resulting in greater than 3 days of abstinence
6. Using other tobacco products more than 9 days in the past 30 days
7. 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)
8. Significant unstable psychiatric conditions (any significant change in psychiatric symptoms during the past 3 months as determined by the licensed medical professional)
9. Schizophrenia and schizoaffective disorder
10. 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.
11. Breath alcohol level \> 0.01
12. Binge drinking alcohol (more than 9 days in the past 30 days, 4/5 drinks in a 2 hour period (female/male))
13. Pregnant, trying to become pregnant or breastfeeding
14. Smoking 'roll your own cigarettes' exclusively
15. 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
16. CO reading \>80 ppm
17. Systolic BP greater than or equal to 160

    * Participants failing for blood pressure will be allowed to re-screen once.
18. Diastolic BP greater than or equal to 100

    * Participants failing for blood pressure will be allowed to re-screen once.
19. Systolic BP below 90

    * Participants failing for blood pressure will be allowed to re-screen once.
20. Diastolic BP below 50

    * Participants failing for blood pressure will be allowed to re-screen once.
21. Heart rate greater than or equal to 105 bpm

    * Participants failing for heart rate will be allowed to re-screen once.
22. Heart rate lower than 45 bpm

    * Participants failing for heart rate will be allowed to re-screen once.
23. 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).
24. Inability to independently read and comprehend the consent form and other written study materials and measures.
25. 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
26. Having participated in Project 1, Study 1 (PRO11060292)
27. Having participated in Project 1, Study 1C (PRO14040384)
28. Household member enrolled in the study concurrently
29. Significant prior adverse reactions to adhesives or latex
30. Participant has a condition that interferes/does not allow for the collection of eligibility criteria

Primary outcomes:
measure: Cigarettes Smoked Per Day
timeFrame: Six Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: Professor, University of Pittsburgh
name: Eric Donny, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.