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

NCT03060083 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: CHRMS 16-395P00044
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tobacco Use Disorder

Outcome Measures

Primary Outcomes (2)

• Feasibility as Indicated by Self-reported Adherence to Study Cigarettes.

  The investigators will use non-adherence to nicotine reduction (i.e., self report of percent non-study cigarettes per day) as an indicator of feasibility.

  Assessed weekly during the 4 week reduction period after the baseline week

• Self Reported Dependence Using the Nicotine Dependence Syndrome Scale (NDSS)

  The NDSS is a measure of dependence that does not rely on cigarettes per day as an indicator of dependence.

  Assessed weekly during the 4 week reduction period after the baseline week

Secondary Outcomes (3)

• Any Quit Attempt (QA)

  Participants were asked at the end of the reduction period whether they made a quit attempt at any point during the 4 week reduction period.

• Number of Participants With Self Reported Seven Day Point Prevalence Abstinence

  Assessed at the end of the 4 week reduction period

• Self-efficacy to Quit Smoking

  Week 0 - Week 4

Study Arms (2)

Switch to VLNC cigarettes

EXPERIMENTAL

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)

Reduce CPD

EXPERIMENTAL

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)

Interventions

Very low nicotine content (VLNC) cigarettes and nicotine replacement therapy (NRT) OTHER

Participants will switch to very low nicotine content (VLNC) cigarettes with the aid of nicotine replacement therapy (NRT)

Switch to VLNC cigarettes

Reduce cigarettes per day (CPD) with nicotine replacement therapy (NRT) OTHER

Participants will reduce cigarettes per day (CPD) with the aid of nicotine replacement therapy (NRT)

Reduce CPD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Vermont: lead

Study Sites (1)

University of Vermont

Burlington, Vermont, 05401, United States

Location

Related Publications (3)

• Klemperer EM, Hughes JR, Callas PW, Benner JA, Morley NE. Effectiveness of switching to very low nicotine content cigarettes plus nicotine patch versus reducing daily cigarette consumption plus nicotine patch to decrease dependence: an exploratory randomized trial. Addiction. 2019 Sep;114(9):1639-1650. doi: 10.1111/add.14666. Epub 2019 Jun 30.

  PMID: 31106492 RESULT

• Klemperer EM, Hughes JR, Callas PW. Increasing Quit Attempts by Transitioning to Very Low Nicotine Content Cigarettes Versus Reducing Number of Cigarettes Per Day: A Secondary Analysis of an Exploratory Randomized Trial. Nicotine Tob Res. 2019 Dec 23;21(Suppl 1):S81-S87. doi: 10.1093/ntr/ntz145.

  PMID: 31867643 RESULT

• Nighbor TD, Klemperer EM, Hughes JR, Reed EN, Simone SJ, West JC. Both reducing cigarettes per day and transitioning to very low-nicotine-content cigarettes decreases demand for usual-brand cigarettes. Exp Clin Psychopharmacol. 2021 Dec;29(6):587-592. doi: 10.1037/pha0000403. Epub 2020 Jul 13.

  PMID: 32658536 RESULT

Related Links

• This is a link to the full dissertation reporting results from this trial

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Tobacco Products; Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture; Drug Therapy; Therapeutics

Results Point of Contact

• Title: Elias M Klemperer
• Organization: University of Vermont

elias.klemperer@med.uvm.edu

8026561641

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Predoctoral Trainee

Study Record Dates

• First Submitted: February 8, 2017
• First Posted: February 23, 2017
• Study Start: February 8, 2017
• Primary Completion: November 16, 2017
• Study Completion: January 10, 2018
• Last Updated: October 4, 2022
• Results First Posted: September 16, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)