NCT02590393: Ecig1

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

Completed Phase 1, PHASE2 Last updated 21 February 2024

What this trial tests

Phase 1, PHASE2 trial testing E-cigarettes in Nicotine Dependence in 20 participants. Completed in 13 January 2022.

Timeline

21 May 2021

Primary endpoint
13 January 2022

13 January 2022

Quick facts

Lead sponsor	Duke University
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	20
Start date	21 May 2021
Primary completion	13 January 2022
Estimated completion	13 January 2022
Sites	1 location across United States

Drugs / interventions tested

• E-cigarettes

Conditions studied

• Nicotine Dependence — all drugs for Nicotine Dependence →

Sponsor

Duke University

Who can join

Adults 21 to 65, any sex, with Nicotine Dependence. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Electronic cigarettes for smoking cessation.
   Hartmann-Boyce J, McRobbie H, Bullen C, Begh R, et al · · 2016 · cited 325× · PMID 27622384 · DOI 10.1002/14651858.cd010216.pub3
2. Electronic cigarettes for smoking cessation.
   Hartmann-Boyce J, McRobbie H, Lindson N, Bullen C, et al · · 2020 · cited 314× · PMID 33052602 · DOI 10.1002/14651858.cd010216.pub4
3. Electronic cigarettes for smoking cessation.
   Hartmann-Boyce J, Lindson N, Butler AR, McRobbie H, et al · · 2022 · cited 147× · PMID 36384212 · DOI 10.1002/14651858.cd010216.pub7
4. Electronic cigarettes for smoking cessation.
   Hartmann-Boyce J, McRobbie H, Lindson N, Bullen C, et al · · 2021 · cited 126× · PMID 33913154 · DOI 10.1002/14651858.cd010216.pub5
5. Electronic cigarettes for smoking cessation.
   Hartmann-Boyce J, McRobbie H, Butler AR, Lindson N, et al · · 2021 · cited 106× · PMID 34519354 · DOI 10.1002/14651858.cd010216.pub6
6. Electronic cigarettes for smoking cessation.
   Lindson N, Butler AR, McRobbie H, Bullen C, et al · · 2024 · cited 94× · PMID 38189560 · DOI 10.1002/14651858.cd010216.pub8
7. Electronic cigarettes for smoking cessation.
   Lindson N, Butler AR, McRobbie H, Bullen C, et al · · 2025 · cited 32× · PMID 39878158 · DOI 10.1002/14651858.cd010216.pub9