Project 1, Study 2: The Combined Impact of Nicotine Replacement and Spectrum Cigarettes

Cigarette Smoking Clinical Trial

Official title:

Project 1, Study 2: The Combined Impact of Nicotine Replacement and Spectrum Cigarettes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02301325
• Other study ID #: U54 DA031659-P1S2
• Secondary ID: 1U54DA031659-01
• Status: Completed
• Phase: N/A
• Start date: November 2014
• Est. completion date: April 2017

Study information

• Verified date: August 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cigarette Smoking

Intervention

Behavioral:
• Smoking research cigarettes with or without NRT

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cigarettes Smoked Per Day		Six Weeks