We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Switching to Very Low Nicotine Content Cigarettes vs Reducing Cigarettes Per Day

This study is currently recruiting participants.
Verified February 2017 by Elias Klemperer, University of Vermont
Sponsor:
ClinicalTrials.gov Identifier:
NCT03060083
First Posted: February 23, 2017
Last Update Posted: February 23, 2017
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.
Information provided by (Responsible Party):
Elias Klemperer, University of Vermont
  Purpose
The FDA recently gained the authority to regulate the nicotine content of cigarettes. Prior research suggests that smokers who switch to very low nicotine content (VLNC) cigarettes experience reduced addiction to nicotine and are more likely to quit smoking. Currently, the most common method for smokers to reduce their nicotine intake is to reduce their number of cigarettes per day (CPD). No research has compared reducing smokers' nicotine intake by switching to VLNC cigarettes vs by reducing CPD with regard to decreasing dependence or quitting; thus the investigators will examine the two strategies by randomizing smokers to 1) switch to VLNC cigarettes or 2) reduce CPD. In addition, all smokers will use the nicotine patch to help them reduce their nicotine intake.

Condition Intervention Phase
Tobacco Use Disorder Other: Very low nicotine content (VLNC) cigarettes and nicotine replacement therapy (NRT) Other: Reduce cigarettes per day (CPD) with nicotine replacement therapy (NRT) Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Randomized Trial to Compare Switching to Very Low Nicotine Content Cigarettes vs Reducing Cigarettes Per Day

Resource links provided by NLM:


Further study details as provided by Elias Klemperer, University of Vermont:

Primary Outcome Measures:
  • Feasibility as indicated by self-reported adherence to study cigarettes. [ Time Frame: 5 weeks ]
    The invstigators will use non-adherence to nicotine reduction (i.e., self report of smoking non-study cigarettes) as an indicator of feasibility.

  • Self reported dependence using the Nicotine Dependence Syndrome Scale (NDSS) [ Time Frame: 5 weeks ]
    The NDSS is a measure of dependence that does not rely on cigarettes per day as an indicator of dependence.


Secondary Outcome Measures:
  • Self-reported quit attempts to stop smoking for good. [ Time Frame: 5 and 9 weeks ]
    Self-reported quit attempts to stop smoking for good.

  • Self reported seven day point prevalence abstinence. [ Time Frame: 5 and 9 weeks ]
    Self reported seven day point prevalence abstinence.

  • Self-efficacy to quit smoking [ Time Frame: 5 and 9 weeks ]
    Velicer's self-efficacy scale is a self-report measure of self-efficacy to quit smoking.

  • Minnesota Nicotine Withdrawal Scale (MNWS) [ Time Frame: 5 weeks ]
    The MNWS is a brief self-report scale to measure nicotine withdrawal symptoms.

  • Questionnaire of Smoking Urges (QSU) [ Time Frame: 5 weeks ]
    The QSU is a self-report measure of craving and urges to smoke.

  • Perceived Health Risks Ratings [ Time Frame: 5 weeks ]
    Self-reported perceived health risks ratings measure perceived risk of addiction and harm from smoking.

  • Cigarette Evaluation Scale (CES) [ Time Frame: 5 Weeks ]
    The CES measures reward satisfaction with self-reported responses to cigarettes.

  • Self-reported reinforcing effect of cigarettes using the Cigarette Purchase Task (CPT). [ Time Frame: 5 weeks ]
    The CPT measures the reinforcing effects of cigarettes by asking participants the number of cigarettes they would consume at varying prices.


Estimated Enrollment: 74
Actual Study Start Date: February 8, 2017
Estimated Study Completion Date: November 30, 2017
Estimated Primary Completion Date: October 31, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Switch to VLNC cigarettes
Participants will be instructed to use nicotine patches and gradually switch to very low nicotine content (VLNC) cigarettes throughout the study period. They will receive regular nicotine cigarettes (16.5 mg/g) during week 1, 11.26 mg/g cigarettes during week 2, 5.54 mg/g cigarettes during week 3, 2.54 mg/g cigarettes during week 4, and 0.44 mg/g cigarettes during week 5.
Other: Very low nicotine content (VLNC) cigarettes and nicotine replacement therapy (NRT)
Participants will switch to very low nicotine content (VLNC) cigarettes with the aid of nicotine replacement therapy (NRT)
Experimental: Reduce CPD
Participants will be instructed to use nicotine patches and gradually reduce the number of regular nicotine content cigarettes that they smoke throughout the study period. They will receive regular nicotine content cigarettes (16.5 mg/g) throughout the study study period. After establishing a baseline CPD during week 1, participants will receive 70% of their baseline CPD during week 2, 35% during week 3, 15% during week 4, and 3% during week 5. Participants will receive a minimum of 1 CPD during week 5.
Other: Reduce cigarettes per day (CPD) with nicotine replacement therapy (NRT)
Participants will reduce cigarettes per day (CPD) with the aid of nicotine replacement therapy (NRT)

  Show Detailed Description

  Eligibility

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 and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Eligibility will be determined based on:

  • participants' age,
  • their cigarettes smoked per day,
  • their intention to quit,
  • their willingness to use medications,
  • prior use of tobacco and non-tobacco nicotine products,
  • prior use of stop-smoking services or medications,
  • DSM 5 criteria for Tobacco Use Disorder,
  • current use of opioid maintenance medications,
  • access to a telephone and the Internet,
  • proximity to the University of Vermont,
  • their bed time,
  • status as a US citizen,
  • comfort speaking, reading and writing in English, and
  • whether or not the participant is breast feeding, pregnant or has the potential to become pregnant or begin breastfeeding during the study period.
  Contacts and Locations
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): NCT03060083


Contacts
Contact: Elias M Klemperer, BA 802-656-1641 elias.klemperer@med.uvm.edu

Locations
United States, Vermont
University of Vermont Recruiting
Burlington, Vermont, United States, 05401
Contact: Elias M Klemperer, BA    802-656-1641    elias.klemperer@med.uvm.edu   
Sponsors and Collaborators
University of Vermont
  More Information

Responsible Party: Elias Klemperer, Predoctoral Trainee, University of Vermont
ClinicalTrials.gov Identifier: NCT03060083     History of Changes
Other Study ID Numbers: CHRMS 16-395
P00044 ( Other Identifier: Center for Tobacco Products )
First Submitted: February 8, 2017
First Posted: February 23, 2017
Last Update Posted: February 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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