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Trial record 1 of 1 for:    Abuse Liability of Reduced Nicotine Content Cigarettes in the Context of Concurrent E-Cigarette Use
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Abuse Liability of Reduced Nicotine Content Cigarettes in the Context of Concurrent E-Cigarette Use (DUAL)

This study is not yet open for participant recruitment.
Verified September 2017 by Jed Rose, Rose Research Center, LLC
Sponsor:
ClinicalTrials.gov Identifier:
NCT02870218
First Posted: August 17, 2016
Last Update Posted: October 2, 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
National Institutes of Health (NIH)
Food and Drug Administration (FDA)
Information provided by (Responsible Party):
Jed Rose, Rose Research Center, LLC
  Purpose
Three hundred-twenty (320) adult smokers of menthol or non-menthol combustible cigarettes will be recruited and randomly assigned to one of five groups (n=64/group), who will be asked to switch for 12 weeks to ad libitum use of combustible cigarettes (matched to subjects' menthol preference) containing either 0.4, 1.4, 2.5, 5.6 or 16.9 mg nicotine (standardized nicotine yields ranging from 0.02-0.80 mg/cigarette), respectively. Each group will include 32 heavy, long-time smokers (≥ 10 cigarettes/day for ≥ 10 years), and 32 light smokers with a shorter smoking history (<10 cigarettes/day for <10 years), who are hypothesized to be more sensitive to nicotine's reinforcing effects. Participants will also have free access to nicotine-containing e-cigarettes (15 mg/ml) throughout the 12-week period. Abuse liability of combustible cigarettes will be assessed by behavioral (cigarettes/day, time to first cigarettes), self-report (rewarding effects, withdrawal symptoms) and biochemical indices (expired air carbon monoxide, cotinine blood sampling).

Condition Intervention Phase
Nicotine Addiction Cigarette Smoking Drug: Smoking research cigarettes with e-cigarette Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Abuse Liability of Reduced Nicotine Content Cigarettes in the Context of Concurrent E-Cigarette Use

Resource links provided by NLM:


Further study details as provided by Jed Rose, Rose Research Center, LLC:

Primary Outcome Measures:
  • Mean number of research cigarettes smoked per day as primary index of abuse liability [ Time Frame: 12 Weeks ]
    To assess the effects of cigarette nicotine content on abuse liability among smokers who also use e-cigarettes. The primary index of abuse liability will be mean number of research cigarettes smoked per day. Secondary outcome measures comprise expired air carbon monoxide (CO), Fagerström Test for Nicotine Dependence (FTND) score, withdrawal symptoms and cognitive performance.


Secondary Outcome Measures:
  • Nicotine discrimination tests to determine detection, recognition and difference thresholds [ Time Frame: Wks 1, 2,8,10,12 and 14 ]
    Results of the laboratory discrimination tests will be analyzed descriptively to determine detection, recognition and difference thresholds. Thresholds will be calculated based on both group-averaged data as well as by using the best estimates of individual thresholds calculated from each smoker's data. Group averaged data will be determined by graphically plotting the overall percent correct against nicotine concentration.

  • Extent of e-cigarette use based on self-report and cotinine levels [ Time Frame: 12 Weeks ]
    To determine whether the abuse liability of combustible cigarettes is related to the nicotine intake from e-cigarettes or to total nicotine intake, regression analyses will be conducted to correlate indices of abuse liability to levels of cotinine as well as to the estimated intake of nicotine from cigarettes and e-cigarettes.


Estimated Enrollment: 320
Anticipated Study Start Date: January 2018
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 0.40mg Nicotine Cigarette w/ e-Cigarette
Participants will be assigned to smoke 0.40mg nicotine Spectrum cigarettes for 12 weeks with unlimited access to 15mg/ml nicotine-containing e-cigarettes.
Drug: Smoking research cigarettes with e-cigarette
Smoking research cigarettes with varying levels of nicotine with unlimited access to 15 mg/ml nicotine-containing e-cigarettes.
Other Names:
  • Spectrum Cigarettes
  • NJOY e-Cigarette
Active Comparator: 1.40mg Nicotine Cigarette w/ e-Cigarette
Participants will be assigned to smoke 1.40mg nicotine Spectrum cigarettes for 12 weeks with unlimited access to 15mg/ml nicotine-containing e-cigarettes.
Drug: Smoking research cigarettes with e-cigarette
Smoking research cigarettes with varying levels of nicotine with unlimited access to 15 mg/ml nicotine-containing e-cigarettes.
Other Names:
  • Spectrum Cigarettes
  • NJOY e-Cigarette
Active Comparator: 2.50mg Nicotine Cigarette w/ e-Cigarette
Participants will be assigned to smoke 2.50mg nicotine Spectrum cigarettes for 12 weeks with unlimited access to 15mg/ml nicotine-containing e-cigarettes.
Drug: Smoking research cigarettes with e-cigarette
Smoking research cigarettes with varying levels of nicotine with unlimited access to 15 mg/ml nicotine-containing e-cigarettes.
Other Names:
  • Spectrum Cigarettes
  • NJOY e-Cigarette
Active Comparator: 5.60mg Nicotine Cigarette w/ e-Cigarette
Participants will be assigned to smoke 5.60mg nicotine Spectrum cigarettes for 12 weeks with unlimited access to 15mg/ml nicotine-containing e-cigarettes.
Drug: Smoking research cigarettes with e-cigarette
Smoking research cigarettes with varying levels of nicotine with unlimited access to 15 mg/ml nicotine-containing e-cigarettes.
Other Names:
  • Spectrum Cigarettes
  • NJOY e-Cigarette
Active Comparator: 16.9mg Nicotine Cigarette w/ e-Cigarette
Participants will be assigned to smoke 16.9mg nicotine Spectrum cigarettes for 12 weeks with unlimited access to 15mg/ml nicotine-containing e-cigarettes.
Drug: Smoking research cigarettes with e-cigarette
Smoking research cigarettes with varying levels of nicotine with unlimited access to 15 mg/ml nicotine-containing e-cigarettes.
Other Names:
  • Spectrum Cigarettes
  • NJOY e-Cigarette

  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 to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subject is healthy as judged by the Investigator based on all available assessments from the Screening Period (e.g., safety laboratory, vital signs, physical examination, ECG, concomitant medications and medical history).
  2. Subject smokes on average four days a week for the last 12 months.
  3. Subject has no intention of quitting smoking within the next 90 days.
  4. Owns a smart phone with text message and data capabilities.
  5. Willingness to use and ability to operate e-cigarettes.
  6. Willingness to smoke Research Cigarettes.

Exclusion Criteria:

  1. Any medical or psychiatric condition (or associated symptoms or medications) determined by a medical professional to be severe enough to be disruptive to the study.
  2. Severe or uncontrolled psychiatric disease with the exception of anxiety disorders, obsessive-compulsive disorder (OCD) and attention deficit hyperactivity disorder (ADHD);
  3. Pregnant or nursing (by self-report) or positive pregnancy test;
  4. Daily use of:

    1. Experimental (investigational) drugs that are unknown to subject;
    2. Smokeless tobacco (chewing tobacco, snuff), cigars, pipes and hookah;
    3. e-cigarettes;
  5. Use in the past 30 days of nicotine replacement therapy or other smoking cessation product
  6. Positive drug screen for cocaine
  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): NCT02870218


Contacts
Contact: Tanaia Loeback 9193282345 tanaia.loeback@roseresearchcenter.com
Contact: David Botts 9193282345 david.botts@roseresearchcenter.com

Locations
United States, North Carolina
Rose Research Center Not yet recruiting
Charlotte, North Carolina, United States, 28262
Contact: Derek Mercedes    704-350-2999    derek.mercedes@roseresearchcenter.com   
Principal Investigator: Jed E Rose, Ph.D.         
Sub-Investigator: James Davis, M.D.         
Rose Research Center Not yet recruiting
Raleigh, North Carolina, United States, 27617
Contact: Tanaia H Loeback       tanaia.loeback@roseresearchcenter.com   
Contact: David Botts       david.botts@roseresearchcener.com   
Principal Investigator: Jed E Rose, Ph.D.         
Sub-Investigator: Perry Willette, M.D.         
Sub-Investigator: James Davis, M.D.         
Sponsors and Collaborators
Rose Research Center, LLC
National Institutes of Health (NIH)
Food and Drug Administration (FDA)
Investigators
Principal Investigator: Jed E Rose, Ph.D. Rose Research Center, LLC
  More Information

Responsible Party: Jed Rose, President and CEO, Rose Research Center, LLC
ClinicalTrials.gov Identifier: NCT02870218     History of Changes
Other Study ID Numbers: 201602820
GRANT12052089 ( Other Identifier: Grants.gov )
First Submitted: August 10, 2016
First Posted: August 17, 2016
Last Update Posted: October 2, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

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