Quit Smoking Study for People Who Use E-Cigarettes
![]() |
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: NCT04946825 |
Recruitment Status :
Recruiting
First Posted : July 1, 2021
Last Update Posted : September 5, 2021
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Nicotine Addiction E-Cig Use Quitting Smoking | Drug: Nicotine replacement therapy patch Drug: Nicotine replacement therapy lozenge Behavioral: Quit electronic cigarettes Behavioral: Continue electronic cigarettes | Phase 2 |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 390 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Randomized Controlled Trial of Smoking Cessation Treatment for Young Adult Dual Users of Combustible and Electronic Cigarettes |
Actual Study Start Date : | June 27, 2021 |
Estimated Primary Completion Date : | August 2023 |
Estimated Study Completion Date : | August 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: Quit cigarettes, but continue using e-cigarettes, with nicotine replacement therapy and text support
Participants in this arm will be instructed to quit tobacco cigarettes with nicotine replacement therapy (patches and lozenges) and text message support. In addition, these participants will be encouraged to continue using electronic cigarettes to help them quit smoking tobacco cigarettes.
|
Drug: Nicotine replacement therapy patch
The nicotine patch is attached to the participant's skin and provides a slight constant stream of nicotine. The smaller dose is meant to reduce nicotine dependence. Drug: Nicotine replacement therapy lozenge The nicotine lozenge contains small amounts of nicotine, which a participant slowly dissolves in their mouth. Like the patch, the smaller dose is meant to reduce nicotine dependence. Behavioral: Continue electronic cigarettes Participants will receive instruction and text message support to continue using electronic cigarettes after they quit combustible cigarettes. |
Experimental: Quit cigarettes and quit e-cigarettes with nicotine replacement therapy and text support.
Participants in this arm will be instructed to quit tobacco cigarettes and quit electronic cigarettes with nicotine replacement therapy (patches and lozenges) and text message support.
|
Drug: Nicotine replacement therapy patch
The nicotine patch is attached to the participant's skin and provides a slight constant stream of nicotine. The smaller dose is meant to reduce nicotine dependence. Drug: Nicotine replacement therapy lozenge The nicotine lozenge contains small amounts of nicotine, which a participant slowly dissolves in their mouth. Like the patch, the smaller dose is meant to reduce nicotine dependence. Behavioral: Quit electronic cigarettes Participants will receive instruction and text message support to quit electronic cigarettes when they quit combustible cigarettes. |
Experimental: Quit cigarettes, but continue using e-cigarettes, with text support.
Participants in this arm will be instructed to quit tobacco cigarettes with text message support. In addition, these participants will be encouraged to continue using electronic cigarettes to help them quit smoking tobacco cigarettes.
|
Behavioral: Continue electronic cigarettes
Participants will receive instruction and text message support to continue using electronic cigarettes after they quit combustible cigarettes. |
Experimental: Quit cigarettes and quit e-cigarettes with text support.
Participants in this arm will be instructed to quit tobacco cigarettes and quit electronic cigarettes with text message support.
|
Behavioral: Quit electronic cigarettes
Participants will receive instruction and text message support to quit electronic cigarettes when they quit combustible cigarettes. |
- Biochemically confirmed 7-day point-prevalence cigarette abstinence [ Time Frame: End of treatment (ie., the 3 month follow up) ]The investigators will report CO confirmed 7-day point-prevalence abstinence from combustible cigarettes at the end of treatment.
- Self-reported 7-day point-prevalence cigarette abstinence [ Time Frame: End of treatment (ie., the 3 month follow up) ]The investigators will report self-reported 7-day point-prevalence abstinence from combustible cigarettes at the end of treatment.
- Adverse events during treatment [ Time Frame: The 3 month treatment period. ]The investigators will report self-reported adverse events during the 3-month treatment period.
- Biochemically confirmed prolonged 30-day abstinence [ Time Frame: The 3-month follow up (ie., end of treatment) and 6-month follow up (3 months after the end of treatment). ]The investigators will report CO confirmed 30-day prolonged abstinence from combustible cigarettes at the 6 month follow up.
- Self-reported prolonged 30-day abstinence [ Time Frame: The 3-month follow up (ie., end of treatment) and 6-month follow up (3 months after the end of treatment). ]The investigators will report self-reported 30-day prolonged abstinence from combustible cigarettes at the 6 month follow up.
- Attempts to quit combustible cigarettes lasting 24 hours or more [ Time Frame: The 3-month treatment period. ]The investigators will report the proportion of participants who made a quit attempt lasting 24 hours or more during treatment.
- Any attempts to quit combustible cigarettes [ Time Frame: The 3-month treatment period. ]The investigators will report the proportion of participants who made a quit attempt lasting any length of time (including very short quit attempts) during treatment.
- Cigarettes per day [ Time Frame: The 3-month treatment period. ]The investigators will report change in cigarettes per day during the 3 month treatment period among participants who continue to smoke cigarettes.
- Cigarette dependence [ Time Frame: The 3-month treatment period. ]The investigators will report change in dependence using the PROMIS nicotine dependence measure during the 3 month treatment period among participants who continue to smoke cigarettes.

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 29 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion criteria:
- Young adult
- Smokes tobacco cigarettes
- Uses electronic cigarettes
- Interested in quitting tobacco
Exclusion criteria:
- Pregnant or planning to become pregnant
- Breastfeeding or planning to start breastfeeding
- One or more contraindications for nicotine replacement therapy
Additional criteria will be assessed to determine eligibility.
If you are interested in participating, please visit the study website to find out if you are eligible: https://www.uvmquitsmokingstudy.org/

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): NCT04946825
Contact: Elias Klemperer, PhD | 8026561641 | elias.klemperer@med.uvm.edu | |
Contact: Shaun Meyers, BA | 8026568681 | shaun.meyers@uvm.edu |
United States, Vermont | |
University of Vermont | Recruiting |
Burlington, Vermont, United States, 05401 | |
Contact: Shaun Meyers, BA 802-656-8681 shaun.meyers@uvm.edu |
Responsible Party: | Elias Klemperer, Assistant Professor, University of Vermont |
ClinicalTrials.gov Identifier: | NCT04946825 |
Other Study ID Numbers: |
STUDY00001059 |
First Posted: | July 1, 2021 Key Record Dates |
Last Update Posted: | September 5, 2021 |
Last Verified: | September 2021 |
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 |
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 |