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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02301325
First Posted: November 25, 2014
Last Update Posted: November 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Wake Forest University Health Sciences
  Purpose
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.

Condition Intervention
Cigarette Smoking Behavioral: Smoking research cigarettes with or without NRT

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Project 1, Study 2: The Combined Impact of Nicotine Replacement and Spectrum Cigarettes

Resource links provided by NLM:


Further study details as provided by Wake Forest University Health Sciences:

Primary Outcome Measures:
  • Cigarettes Smoked Per Day [ Time Frame: Six Weeks ]

Enrollment: 240
Study Start Date: November 2014
Study Completion Date: April 2017
Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
0.03 mg Nicotine Cigarette
Participants will be assigned to smoke 0.03 mg nicotine Spectrum cigarettes
Behavioral: Smoking research cigarettes with or without NRT
0.03 mg Nicotine Cigarette and NRT
Participants will be assigned to smoke 0.03 mg nicotine Spectrum cigarettes and use nicotine replacement patches.
Behavioral: Smoking research cigarettes with or without NRT
0.80 mg Nicotine Cigarette
Participants will be assigned to smoke 0.80 mg nicotine Spectrum cigarettes.
Behavioral: Smoking research cigarettes with or without NRT
0.80 mg Nicotine Cigarette and NRT
Participants will be assigned to smoke 0.80 mg nicotine Spectrum cigarettes and use nicotine replacement patches.
Behavioral: Smoking research cigarettes with or without NRT

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02301325


Locations
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15260
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
Principal Investigator: Eric Donny, Ph.D. Professor, University of Pittsburgh
  More Information

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT02301325     History of Changes
Other Study ID Numbers: U54 DA031659-P1S2
First Submitted: November 21, 2014
First Posted: November 25, 2014
Last Update Posted: November 8, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action