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Quit Smoking Study for People Who Use E-Cigarettes

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ClinicalTrials.gov Identifier: NCT04946825
Recruitment Status : Recruiting
First Posted : July 1, 2021
Last Update Posted : September 5, 2021
Sponsor:
Information provided by (Responsible Party):
Elias Klemperer, University of Vermont

Brief Summary:
The overarching aim of this proposed randomized controlled trial (RCT) is to test nicotine replacement therapy (NRT) with text message support for two smoking cessation approaches among young adult dual users of combustible cigarettes (CC) and electronic cigarettes (EC). The investigators will use a 2x2 factorial design to randomize 390 participants to receive A) NRT plus text messages to quit CCs only, B) NRT plus text messages to quit CCs and ECs simultaneously, C) text messages alone to quit CCs only, or D) text messages alone to quit CCs and ECs simultaneously. The investigators primary outcome will be 7-day point-prevalence abstinence at the end of treatment (i.e., 3 months after randomization). The investigators will recruit participants using national advertising strategies. All treatment will be provided remotely in order to increase treatment access and comply with current COVID-19 restrictions.

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

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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

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 29 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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/


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): NCT04946825


Contacts
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Contact: Elias Klemperer, PhD 8026561641 elias.klemperer@med.uvm.edu
Contact: Shaun Meyers, BA 8026568681 shaun.meyers@uvm.edu

Locations
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United States, Vermont
University of Vermont Recruiting
Burlington, Vermont, United States, 05401
Contact: Shaun Meyers, BA    802-656-8681    shaun.meyers@uvm.edu   
Sponsors and Collaborators
University of Vermont
Additional Information:
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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

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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.: Yes
Additional relevant MeSH terms:
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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