Innovative Interventions for Smoking Cessation

Innovative Interventions for Smoking Cessation: Comparison of Very Low Nicotine Content Cigarettes Plus Nicotine Patch; Very Low Nicotine Content Cigarettes Alone or Nicotine Patch Alone

The purpose of this study is to evaluate the effect of a combination of the 21 mg nicotine patch and very low nicotine content (VLNC) cigarettes compared to 21 mg nicotine patch only and very low nicotine content cigarette only on abstinence, time to relapse and toxicant levels. The study will determine if adding nicotine replacement medication to the very low content cigarettes (VLNC) will augment treatment compared to nicotine patch only or to very low nicotine content cigarettes only.

Study Overview

• Status: Completed
• Conditions: Tobacco Use Disorder
• Intervention / Treatment: Drug: Nicotine Patch; Other: VLNC Cigarette; Other: VLNC Cigarette Plus Nicotine Patch

Detailed Description

The purpose of this study is to evaluate the effect of a combination of the 21 mg nicotine patch and very low nicotine content cigarette (VLNC) compared to the VLNC cigarette alone or 21 mg nicotine patch alone on abstinence, time to relapse and toxicant levels.

The following primary hypothesis will be tested:

Abstinence rates will be highest and the time to relapse will be the longest in the VLNC cigarettes plus nicotine patch condition compared to nicotine patch or VLNC cigarettes alone.

Other hypotheses include:

1. Greater positive subjective responses to cigarettes will be observed with VLNC cigarettes plus patch vs. VLNC cigarette;
2. Less drop-outs will be observed in the VLNC plus patch vs the other two conditions; and
3. Less compensatory smoking will be observed in the VLNC plus patch condition compared to VLNC cigarette alone condition.

Cigarette smokers will be randomized to:

1. VLNC cigarettes (which provide sensory behavioral aspects of smoking but with limited nicotine) plus nicotine patch for 6 weeks;
2. Nicotine patch for 6 weeks; or
3. VLNC cigarettes alone.

Outcome measures will include cessation assessed at the end of treatment as the primary endpoint and at 36 weeks post-treatment, time to lapse and relapse to usual brand cigarettes, and biomarkers of toxicant exposure. Predictors of abstinence and treatment response for each of the treatment conditions will be explored.

• Study Type: Interventional
• Enrollment (Actual): 235
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Duluth, Minnesota, United States, 55812
      • University of Minnesota
    • Minneapolis, Minnesota, United States, 55414
      • University of MN's Tobacco Use Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• a) Smoking at least 10 cigarettes daily for the past year;
• b) In good physical health;
• c) No contraindications for medicinal nicotine; and
• d) Stable, good mental health.

Exclusion Criteria:

• a) Subjects must not be using other tobacco or nicotine products.
• b) Female subjects cannot be pregnant or nursing and must be using appropriate birth control.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: VLNC Cigarette; Very Low Nicotine Content Cigarette. Dosage: 0.05 mg to 0.09 mg nicotine yield cigarette; Frequency: Daily; Duration: 6 weeks.	Other: VLNC Cigarette; Cigarette where the tobacco contains <0.1 mg of nicotine yield.; Other Names: Quest 3; Xodus
Active Comparator: Nicotine Patch; 21 mg nicotine patch. Dosage: 21 mg; Frequency: Daily; Duration: 6 weeks.	Drug: Nicotine Patch; 21 mg; Other Names: Nicoderm CQ
Experimental: VLNC Cigarette plus Nicotine Patch; Very Low Nicotine Content Cigarette plus 21 mg Nicotine Patch. Patch Dosage: 21 mg; Cigarette Dosasge: 0.05 to 0.09 mg nicotine yield; Frequency: Daily; Duration: 6 weeks	Other: VLNC Cigarette Plus Nicotine Patch; 21 mg nicotine patch plus use of cigarette with tobacco containing <0.1 mg nicotine yield.; Other Names: Nicoderm CQ; Quest 3; Xodus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
End of Treatment Abstinence Rate	Cotinine and carbon monoxide (CO) verified point prevalence abstinence	12 week
End of Follow-up Abstinence Rates	CO- and cotinine-verified point prevalence abstinence	36 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Exposure to Tobacco Toxicants	6 weeks
Time to Lapse or Relapse to Tobacco Use	26 weeks

Collaborators and Investigators

• Sponsor: University of Minnesota
• Collaborators: National Institute on Drug Abuse (NIDA)

Publications and helpful links

General Publications

• Dermody SS, Donny EC, Hertsgaard LA, Hatsukami DK. Greater reductions in nicotine exposure while smoking very low nicotine content cigarettes predict smoking cessation. Tob Control. 2015 Nov;24(6):536-9. doi: 10.1136/tobaccocontrol-2014-051797. Epub 2014 Sep 5.
• Hatsukami DK, Hertsgaard LA, Vogel RI, Jensen JA, Murphy SE, Hecht SS, Carmella SG, al'Absi M, Joseph AM, Allen SS. Reduced nicotine content cigarettes and nicotine patch. Cancer Epidemiol Biomarkers Prev. 2013 Jun;22(6):1015-24. doi: 10.1158/1055-9965.EPI-12-1439. Epub 2013 Apr 19.

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: January 14, 2010
• First Submitted That Met QC Criteria: January 14, 2010
• First Posted (Estimate): January 15, 2010

Study Record Updates

• Last Update Posted (Actual): November 18, 2019
• Last Update Submitted That Met QC Criteria: October 30, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Smoking Cessation; Nicotine Free Cigarettes
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: 0409M63686; 1R01DA025598 (U.S. NIH Grant/Contract)