ClinicalTrials.gov
ClinicalTrials.gov Menu

The Role of Nicotine and Non-Nicotine Alkaloids in E-Cigarette Use and Dependence (Ecig1)

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: NCT02590393
Recruitment Status : Not yet recruiting
First Posted : October 29, 2015
Last Update Posted : October 9, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Duke University

Brief Summary:
The purpose of this study is to learn more about the nicotine and non-nicotine chemicals that are part of e-cigarettes and their effects on cigarette smokers by assessing smokers' experiences with different e-cigarettes using a battery of self-report, biochemical, and behavioral indices. This is not a smoking cessation study; smokers will not be asked to quit smoking, and e-cigarettes will not be used as a medical device or therapy.

Condition or disease Intervention/treatment Phase
Nicotine Dependence Combination Product: E-cigarettes Phase 3

Detailed Description:

The study will shed light on the behavioral effects of: 1) varying e-cigarette nicotine content, known to be important in maintaining conventional cigarette use; and 2) varying e-cigarette non-nicotine tobacco alkaloid (NNTA) content, about which little is known regarding the role in product use or dependence. The study will assess the effects of e-cigarette nicotine and NNTA content on cigarette smokers who will be randomized to conditions that manipulate the nicotine and NNTA content of e-cigarettes.

The study will include N = 375 adult smokers of menthol or non-menthol cigarettes with randomization of enrolled participants to one of three groups (125/group).

Group 1: Nicotine + NNTAs. (Standard Nicotine Standard NNTA group) E-cigarette cartridges will contain tobacco extract with nicotine + NNTA amounts in the range of typical commercial cigarettes, with a ratio of NNTA:nicotine that is also typical of commercial cigarettes.

Group 2: Nicotine control (Standard Nicotine Low NNTA group). E-cigarette cartridges will contain the same concentration of nicotine, but 1/10th of NNTAs as in Group 1. This group will control for nicotine content and allow for evaluation of the roll of various levels of NNTAs in e-cigarette use.

Group 3: Vehicle control (Low Nicotine, Low NNTA Group). E-cigarette cartridges will contain less than 1/10 of the nicotine in the other two groups, and NNTA levels will be correspondingly low. This group will control for changes in cigarette consumption that may occur due to study participation or to the non-nicotine behavioral/sensory factors entailed in e-cigarette use, which could influence cigarette consumption.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 375 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Basic Science
Official Title: The Role of Nicotine and Non-Nicotine Alkaloids in E-Cigarette Use and Dependence
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: E-Cigarettes

Arm Intervention/treatment
Active Comparator: Nicotine + NNTAs
Participants will be asked to switch from cigarette use to use of e-cigarettes for eight weeks. E-cigarette cartridges will contain tobacco extract with nicotine + NNTAs in a vehicle of propylene glycol. The yields of nicotine and NNTAs will be in the range of typical commercial cigarettes (e.g., 0.6 mg nicotine delivered in 10 puffs of 35 mL), with a ratio of NNTA:nicotine yield that is also typical of commercial cigarettes.
Combination Product: E-cigarettes
Participants will be asked to switch from cigarette use to use of e-cigarettes for eight weeks.
Other Names:
  • Electronic Nicotine Delivery System (ENDS)
  • e-cigs
  • electronic cigarettes

Active Comparator: Nicotine control
Participants will be asked to switch from cigarette use to use of e-cigarettes for eight weeks. E-cigarette cartridges will contain the same concentration of nicotine, but very low amounts (1/10th) of NNTAs as in Group 1. This specialized product will be developed from low nicotine, low NNTA content tobacco extract currently used in the "Spectrum" cigarettes offered as part of the National Institute on Drug Abuse (NIDA) drug supply program. This extract will then be fortified with additional nicotine to match nicotine levels in Group 1. A propylene glycol vehicle will remain the same as in Group 1.
Combination Product: E-cigarettes
Participants will be asked to switch from cigarette use to use of e-cigarettes for eight weeks.
Other Names:
  • Electronic Nicotine Delivery System (ENDS)
  • e-cigs
  • electronic cigarettes

Active Comparator: Vehicle control
Participants will be asked to switch from cigarette use to use of e-cigarettes for eight weeks. E-cigarette cartridges will contain only propylene glycol vehicle and extract from low nicotine/NNTA content tobacco. The nicotine yield will be less than 0.05 mg per 10 puffs of 35 mL, i.e., less than 1/10 of the yield in the other two groups, and NNTA yield will be correspondingly low.
Combination Product: E-cigarettes
Participants will be asked to switch from cigarette use to use of e-cigarettes for eight weeks.
Other Names:
  • Electronic Nicotine Delivery System (ENDS)
  • e-cigs
  • electronic cigarettes




Primary Outcome Measures :
  1. Expired air carbon monoxide (CO) to assess recent smoking [ Time Frame: Week 8 ]
    The effects of e-cigarette nicotine content and non-nicotine alkaloid (NNTA) content on the concurrent use of conventional cigarettes will be assessed by comparing Group 1 to Group 2 and Group 2 to Group 3 (respectively) on the expired air carbon monoxide (CO) measured at the end of the exposure period (Week 8).


Secondary Outcome Measures :
  1. Mean volume of e-cigarette solution used per day to assess e-cigarette use. [ Time Frame: Week 8 ]
    The effects of e-cigarette nicotine content and non-nicotine alkaloid (NNTA) content on the use of e-cigarettes will be assessed by comparing Group 1 to Group 2 and Group 2 to Group 3 (respectively) on mean volume of solution used per day (by measuring the content of cartridges returned at each visit), calculated at the end of week 8.

  2. Cigarette use, assessed by self-report in daily dairies [ Time Frame: Week 8 ]
    The effects of e-cigarette nicotine content and non-nicotine alkaloid (NNTA) content on the concurrent use of conventional cigarettes will be assessed by comparing the groups on self-report of cigarette consumption on daily diaries, totalled at the end of week 8.

  3. E-cigarette use, assessed by self-report in daily dairies [ Time Frame: Week 8 ]
    The effects of e-cigarette nicotine content and non-nicotine alkaloid (NNTA) content on the concurrent use of e-cigarettes will be assessed by comparing the groups on self-report of e-cigarette use on daily diaries, totalled at the end of week 8.



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, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have no known serious medical conditions;
  • Are 18-65 years old;
  • Smoke an average of at least 10 cigarettes per day;
  • Have smoked at least one cumulative year;
  • Have an expired air CO reading of at least 10ppm;
  • Are able to read and understand English.

Potential subjects must agree to use acceptable contraception during their participation in this study. Potential subjects must agree to avoid the following during their participation in this study:

  • Participation in any other nicotine-related modification strategy outside of this protocol;
  • Use of tobacco products other than cigarettes, including pipe tobacco, cigars, snuff, and chewing tobacco;
  • Use of e-cigarettes other than the ones provided during the study;
  • Use of experimental (investigational) drugs or devices;
  • Use of illegal drugs.

Exclusion Criteria:

  • Intent to quit smoking with FDA approved pharmaceutical products within the next 90 days;
  • Hypertension (systolic >160 mm Hg, diastolic >100 mm Hg. Participants with a history of hypertension may, however, be allowed to participate in the study if the study physician or physician assistant determines that the condition is stable, controlled by medication, and in no way jeopardizes the individual's safety;
  • Coronary heart disease;
  • Lifetime history of heart attack;
  • Clinically significant cardiac rhythm disorder (irregular heart rhythm);
  • Chest pains (unless history, exam, and ECG clearly indicate a non-cardiac source);
  • Clinically significant cardiac (heart) disorder (including but not limited to valvular heart disease, heart murmur, heart failure);
  • Clinically significant liver or kidney disorder (except kidney stones, gallstones);
  • Clinically significant gastrointestinal problems or disease;
  • Active ulcer in the past 30 days;
  • Migraine headaches that occur more frequently than once per week;
  • Clinically significant symptomatic lung disorder (including but not limited to chronic obstructive pulmonary disease (COPD), emphysema, and asthma);
  • Recent history of fainting;
  • Problems giving blood samples;
  • Diabetes;
  • Current cancer or treatment for cancer in the past six months (except basal or squamous cell skin cancer);
  • Other major medical condition;
  • Current psychiatric disease (with the exception of anxiety disorders, obsessive compulsive disorder (OCD) and Attention Deficit Hyperactivity Disorder (ADHD));
  • Current depression;
  • Pregnant or nursing mothers;
  • Chronic use of opiate medications for pain or sleep (non-opiate medication for pain or sleep will be allowed);
  • Use (within the past 30 days) of: Illegal drugs (or if the urine drug screen is positive); Experimental (investigational) drugs; Psychiatric medications including antidepressants, anti-psychotics or any other medications that are known to affect smoking cessation (e.g. clonidine); Smokeless tobacco (chewing tobacco, snuff), e-cigarettes, pipes, nicotine replacement therapy, or other smoking cessation treatment; E-cigarettes;
  • Smoking more than one cigar a month;
  • Self-report of consuming 4 or more alcoholic drinks on 4 or more days per week;
  • Current participation or recent participation (in the past 30 days) in another smoking study at our Center or another research facility.

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): NCT02590393


Contacts
Contact: Jed Rose, Ph.D. (919) 668-5055 rose0003@mc.duke.edu

Locations
United States, North Carolina
Duke Center for Smoking Cessation Not yet recruiting
Durham, North Carolina, United States, 27705
Contact: Jed Rose, Ph.D.    919-668-5055      
Sponsors and Collaborators
Duke University
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Jed Rose, Ph.D. Duke University

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02590393     History of Changes
Other Study ID Numbers: Pro00059780
1R01DA038554-01 ( U.S. NIH Grant/Contract )
First Posted: October 29, 2015    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018

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.: Yes

Keywords provided by Duke University:
Nicotine addiction
Cigarette smoking
E-cigarettes

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
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