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

Primary Purpose

Nicotine Dependence

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
E-cigarettes
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Nicotine Dependence focused on measuring Nicotine addiction, Cigarette smoking, E-cigarettes

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Have no known serious medical conditions;
  • Are 21-65 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:

  • Actively seeking treatment for nicotine dependence;
  • Uncontrolled high blood pressure (self-report);
  • Coronary heart disease with symptoms (e.g., chest pain);
  • Heart attack in the past year;
  • Cardiac rhythm disorder (irregular heart rhythm with symptoms);
  • Chest pain in the last month (unless history indicates a non-cardiac source);
  • Symptomatic heart disorder such as heart failure;
  • Advanced liver or kidney disease that requires medication or dialysis, paracentesis;
  • Bleeding stomach ulcers in the past 30 days;
  • Lung disease that requires oxygen;
  • Major brain disorder (including stroke with residual deficit, brain tumor, and seizure disorder);
  • Migraine headaches that occur more frequently than once per week;
  • Recent, unexplained fainting spells;
  • Diabetes with insulin use;
  • Current cancer or treatment for cancer in the past six months (except basal or squamous cell skin cancer);
  • Other major medical condition (as determined by study medical provider);
  • Diagnosis of thought disorder; such as bipolar disorder or schizophrenia;
  • Psychiatric hospitalization within the past 12 months;
  • Pregnant or nursing mothers;
  • Use (within the past 7 days) of illegal drugs (or if the urine drug screen is positive for THC, Cocaine, Amphetamine, Opiates, Methamphetamines, PCP, Benzodiazepines, or Barbiturates), unless recent use of prescription opiates or benzodiazepines were taken for management of acute symptoms (e.g., tooth extraction, recent surgery, or sleep);
  • Use of experimental (investigational) drugs within the past 7 days;
  • Use of psychiatric medications including antidepressants and anti-psychotics may be permitted if the condition is stable (study medical provider discretion).
  • Use of opiates, benzodiazepines, and muscle relaxants (unless taken for sleep or acute symptoms such as tooth extraction or recent surgery) within the past 7 days (study medical provider discretion);
  • Use of Wellbutrin, bupropion, Zyban, Chantix, varenicline, nicotine patch, nicotine replacement therapy, clonidine or any other smoking cessation aid within the past 30 days;
  • Use of cigars, pipes, Hookah, dissolvable nicotine, snuff, chewing tobacco, or e-cigarettes within the past 7 days;
  • Diagnosis of alcohol abuse or dependence or self-report of consuming more than 6 drinks on one occasion more than one day per week;
  • Significant adverse reaction to nicotine patch in the past;
  • Current or recent participation (in the past 30 days) in another smoking treatment study at our Center or another research facility;

Sites / Locations

  • Duke Center for Smoking Cessation

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nicotine + NNTAs

Arm Description

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 and vegtable glycerin, with tobacco or menthol flavor matched to each participant's preference. The yields of nicotine and NNTAs will be in the range of typical commercial cigarettes.

Outcomes

Primary Outcome Measures

Change in expired air carbon monoxide (CO) to assess recent smoking
Self-reported changes in cigarette use from baseline to week 8, expressed as a percentage of baseline values, will be calculated, based on expired air carbon monoxide readings.

Secondary Outcome Measures

Mean volume of e-cigarette solution used per day to assess e-cigarette use.
The mean volume of solution used per day (by measuring the content and number of pods returned) will be calculated for each week.
Change in cigarette use, assessed by self-report in daily dairies
Self-reported changes in cigarette use from baseline to week 8, expressed as a percentage of baseline values, will be calculated, based on cigarette consumption recorded in daily diaries.
E-cigarette use, assessed by self-report in daily dairies
The self-reported use of e-cigarette pods, based on daily diaries, will be totaled for each week.
Change in Nicotine dependence
The change in level of nicotine dependence will be assessed by administering the Fagerstrom Test for Nicotine Dependence questionnaire, administered at baseline and at week 8.
Satisfaction ratings
The satisfaction of the experimental e-cigarette formulation will be assessed using the modified Cigarette Evaluation Questionnaire, with wording adapted to e-cigarettes.

Full Information

First Posted
October 27, 2015
Last Updated
April 28, 2022
Sponsor
Duke University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT02590393
Brief Title
The Role of Nicotine and Non-Nicotine Alkaloids in E-Cigarette Use and Dependence
Acronym
Ecig1
Official Title
The Role of Nicotine and Non-Nicotine Alkaloids in E-Cigarette Use and Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
May 21, 2021 (Actual)
Primary Completion Date
January 13, 2022 (Actual)
Study Completion Date
January 13, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

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

5. Study Description

Brief Summary
The advent of electronic cigarette (e-cigarette) technologies represents one of the most significant developments in the last several decades, and provides a novel and promising strategy for substantially reducing the morbidity and mortality associated with smoking. However, serious concerns have been raised regarding the possibility that e-cigarettes will sustain a dependency on nicotine and that they may lead to continued use of conventional cigarettes known to be extremely harmful to health. Cigarette addiction critically involves a dependence on nicotine, but it is likely that other tobacco constituents contribute to dependence as well. Recent evidence suggests that non-nicotine tobacco alkaloids, or NNTAs (including anabasine, anatabine, nornicotine, and myosmine) may play a role in tobacco dependence. These alkaloids have been shown to augment the reinforcing effects of nicotine in animal models and to affect cravings in human smokers. E-cigarettes contain variable quantities of nicotine and NNTAs, but there is virtually no information available concerning the role of e-cigarette nicotine or NNTA content in influencing the concurrent use of cigarettes and e-cigarettes, when smokers attempt to switch from conventional combustible cigarettes to e-cigarettes. Additionally, it is not known whether the presence of nicotine and NNTAs in e- cigarettes may sustain dependence, making it difficult to relinquish these products. The proposed project will assess the acceptability, extent of switching behavior, and degree of dependence maintained when smokers are provided with e-cigarettes containing nicotine and NNTAs.
Detailed Description
A single group of thirty smokers will be recruited for the study to provide initial data to inform follow-up randomized controlled trials. Dependence and concurrent use of e-cigarettes and cigarettes will be assessed by a battery of self-report, biochemical, and behavioral indices. This is not a tobacco cessation study and there is no intent to use e-cigarettes as a smoking cessation treatment. Smokers will be asked to use the e-cigarettes instead of their regular cigarettes during the study. E-cigarettes will not be used for the purpose of reducing urges, withdrawal or nicotine dependence; and e-cigarettes will not be described or used as a medical device or therapy. Specific Aim 1: To assess the extent of switching from combustible cigarettes to e-cigarettes delivering nicotine along with NNTAs. Switching will be assessed by self-report diaries and by reductions in expired air carbon monoxide, an index of combustible cigarette use. Specific Aim 2: To assess the acceptability of e-cigarettes delivering nicotine along with NNTAs. Ratings of user satisfaction and other subjective effects will be collected from participants, for both their customary brand of cigarettes and the e-cigarette to be used. Specific Aim 3: To determine the extent of dependence maintained during use of e-cigarettes delivering nicotine with NNTAs, as well as the relationship between dependence and self-reported use of cigarettes and e-cigarettes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence
Keywords
Nicotine addiction, Cigarette smoking, E-cigarettes

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nicotine + NNTAs
Arm Type
Experimental
Arm Description
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 and vegtable glycerin, with tobacco or menthol flavor matched to each participant's preference. The yields of nicotine and NNTAs will be in the range of typical commercial cigarettes.
Intervention Type
Combination Product
Intervention Name(s)
E-cigarettes
Other Intervention Name(s)
Electronic Nicotine Delivery System (ENDS), e-cigs, electronic cigarettes
Intervention Description
Participants will be asked to switch from cigarette use to use of e-cigarettes for eight weeks.
Primary Outcome Measure Information:
Title
Change in expired air carbon monoxide (CO) to assess recent smoking
Description
Self-reported changes in cigarette use from baseline to week 8, expressed as a percentage of baseline values, will be calculated, based on expired air carbon monoxide readings.
Time Frame
Weeks 1-8
Secondary Outcome Measure Information:
Title
Mean volume of e-cigarette solution used per day to assess e-cigarette use.
Description
The mean volume of solution used per day (by measuring the content and number of pods returned) will be calculated for each week.
Time Frame
Weeks 1-8
Title
Change in cigarette use, assessed by self-report in daily dairies
Description
Self-reported changes in cigarette use from baseline to week 8, expressed as a percentage of baseline values, will be calculated, based on cigarette consumption recorded in daily diaries.
Time Frame
Weeks 1-8
Title
E-cigarette use, assessed by self-report in daily dairies
Description
The self-reported use of e-cigarette pods, based on daily diaries, will be totaled for each week.
Time Frame
Weeks 1-8
Title
Change in Nicotine dependence
Description
The change in level of nicotine dependence will be assessed by administering the Fagerstrom Test for Nicotine Dependence questionnaire, administered at baseline and at week 8.
Time Frame
Weeks 1-8.
Title
Satisfaction ratings
Description
The satisfaction of the experimental e-cigarette formulation will be assessed using the modified Cigarette Evaluation Questionnaire, with wording adapted to e-cigarettes.
Time Frame
Weeks 1-8.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have no known serious medical conditions; Are 21-65 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: Actively seeking treatment for nicotine dependence; Uncontrolled high blood pressure (self-report); Coronary heart disease with symptoms (e.g., chest pain); Heart attack in the past year; Cardiac rhythm disorder (irregular heart rhythm with symptoms); Chest pain in the last month (unless history indicates a non-cardiac source); Symptomatic heart disorder such as heart failure; Advanced liver or kidney disease that requires medication or dialysis, paracentesis; Bleeding stomach ulcers in the past 30 days; Lung disease that requires oxygen; Major brain disorder (including stroke with residual deficit, brain tumor, and seizure disorder); Migraine headaches that occur more frequently than once per week; Recent, unexplained fainting spells; Diabetes with insulin use; Current cancer or treatment for cancer in the past six months (except basal or squamous cell skin cancer); Other major medical condition (as determined by study medical provider); Diagnosis of thought disorder; such as bipolar disorder or schizophrenia; Psychiatric hospitalization within the past 12 months; Pregnant or nursing mothers; Use (within the past 7 days) of illegal drugs (or if the urine drug screen is positive for THC, Cocaine, Amphetamine, Opiates, Methamphetamines, PCP, Benzodiazepines, or Barbiturates), unless recent use of prescription opiates or benzodiazepines were taken for management of acute symptoms (e.g., tooth extraction, recent surgery, or sleep); Use of experimental (investigational) drugs within the past 7 days; Use of psychiatric medications including antidepressants and anti-psychotics may be permitted if the condition is stable (study medical provider discretion). Use of opiates, benzodiazepines, and muscle relaxants (unless taken for sleep or acute symptoms such as tooth extraction or recent surgery) within the past 7 days (study medical provider discretion); Use of Wellbutrin, bupropion, Zyban, Chantix, varenicline, nicotine patch, nicotine replacement therapy, clonidine or any other smoking cessation aid within the past 30 days; Use of cigars, pipes, Hookah, dissolvable nicotine, snuff, chewing tobacco, or e-cigarettes within the past 7 days; Diagnosis of alcohol abuse or dependence or self-report of consuming more than 6 drinks on one occasion more than one day per week; Significant adverse reaction to nicotine patch in the past; Current or recent participation (in the past 30 days) in another smoking treatment study at our Center or another research facility;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jed Rose, Ph.D.
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Center for Smoking Cessation
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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