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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)

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.
 
ClinicalTrials.gov Identifier: NCT02870218
Recruitment Status : Recruiting
First Posted : August 17, 2016
Last Update Posted : March 10, 2020
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Food and Drug Administration (FDA)
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Jed Rose, Rose Research Center, LLC

Brief Summary:

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 (≥ 20 cigarettes/day), and 32 light smokers (≤10 cigarettes/day), who are hypothesized to be more sensitive to nicotine's reinforcing effects. Participants will also have free access to nicotine-containing e-cigarettes (JUUL) 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).

In laboratory sessions, we will measure nicotine thresholds for detecting and recognizing the addictive, rewarding effects of smoking. This study is designed to help the FDA identify a target nicotine threshold that will not attract young people to smoking or induce relapse in former smokers. Additionally, we will determine the level of cigarette nicotine reduction that will be tolerated without inducing dissatisfaction in smokers, information that is relevant to the FDA for designing a stepwise nicotine reduction policy that can be implemented without widespread objections. The knowledge gained from this project will greatly increase our knowledge of nicotine addiction and will help frame an FDA policy relating to the regulation of the nicotine content of tobacco. Ultimately, a well-designed nicotine reduction policy has the potential to greatly reduce the enormous toll of death and disease caused by cigarette smoking.


Condition or disease Intervention/treatment Phase
Nicotine Addiction Cigarette Smoking Drug: Smoking research cigarettes with e-cigarette Drug: Nicotine discrimination thresholds Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
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
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: E-Cigarettes Smoking

Arm Intervention/treatment
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 JUUL e-cigarettes.

Smoking research cigarettes with e-cigarette

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
  • JUUL 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 JUUL e-cigarettes.

Smoking research cigarettes with e-cigarette

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
  • JUUL 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 JUUL e-cigarettes.

Smoking research cigarettes with e-cigarette

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
  • JUUL 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 JUUL e-cigarettes.

Smoking research cigarettes with e-cigarette

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
  • JUUL 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 JUUL e-cigarettes.

Smoking research cigarettes with e-cigarette

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
  • JUUL e-Cigarette

Experimental: Halo G6 & Tribeca e-liquid

Difference detection assessments.

Nicotine discrimination thresholds

Drug: Nicotine discrimination thresholds
Measure of nicotine thresholds for detecting and recognizing the addictive, rewarding effects of smoking.
Other Name: Halo G6 with Tribeca e-liquid

Experimental: Spectrum Research Cigarette

Difference detection assessments.

Nicotine discrimination thresholds

Drug: Nicotine discrimination thresholds
Measure of nicotine thresholds for detecting and recognizing the addictive, rewarding effects of smoking.
Other Name: Halo G6 with Tribeca e-liquid




Primary Outcome Measures :
  1. Expired air CO Measurement [ Time Frame: 12 Weeks ]
    To determine the effects of cigarette nicotine content manipulations on abuse liability as measured by exhaled breath CO.


Secondary Outcome Measures :
  1. Nicotine discrimination tests to determine nicotine detection thresholds [ Time Frame: Weeks 1, 2,8,10,12 and 14 ]
    Results of the laboratory discrimination tests will be analyzed descriptively to determine nicotine detection 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.

  2. Nicotine discrimination tests to determine nicotine recognition thresholds [ Time Frame: Weeks 1, 2,8,10,12 and 14 ]
    Results of the laboratory discrimination tests will be analyzed descriptively to determine nicotine recognition 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.

  3. Extent of e-cigarette use based on self-report [ 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 based on self-reported values.

  4. Extent of e-cigarette use based on self-report 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.

  5. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older 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

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

Locations
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United States, North Carolina
Rose Research Center 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: Perry Willette, M.D.         
Rose Research Center Recruiting
Raleigh, North Carolina, United States, 27617
Contact: Stacy L Drew, MS, MHS, PA-C       stacy.drew@roseresearchcenter.com   
Contact: Tanaia Loeback       tanaia.loeback@roseresearchcener.com   
Principal Investigator: Jed E Rose, Ph.D.         
Sub-Investigator: Perry Willette, M.D.         
Sponsors and Collaborators
Rose Research Center, LLC
National Institutes of Health (NIH)
Food and Drug Administration (FDA)
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Jed E Rose, Ph.D. Rose Research Center, LLC
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Responsible Party: Jed Rose, President and CEO, Rose Research Center, LLC
ClinicalTrials.gov Identifier: NCT02870218    
Other Study ID Numbers: 201602820
GRANT12052089 ( Other Identifier: Grants.gov )
5R01DA042541-03 ( U.S. NIH Grant/Contract )
First Posted: August 17, 2016    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Nicotine
Behavior, Addictive
Compulsive Behavior
Impulsive Behavior
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