Innovative Interventions for Smoking Cessation

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01050569
First received: January 14, 2010
Last updated: January 14, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Tobacco Use Disorder
Drug: Nicotine Patch
Other: VLNC Cigarette
Other: VLNC Cigarette Plus Nicotine Patch
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • End of Treatment Abstinence Rate [ Time Frame: 12 week ] [ Designated as safety issue: No ]
    Cotinine and carbon monoxide (CO) verified point prevalence abstinence

  • End of Follow-up Abstinence Rates [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
    CO- and cotinine-verified point prevalence abstinence


Secondary Outcome Measures:
  • Exposure to Tobacco Toxicants [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • Time to Lapse or Relapse to Tobacco Use [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Enrollment: 235
Study Start Date: October 2008
Study Completion Date: June 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01050569

Locations
United States, Minnesota
University of Minnesota
Duluth, Minnesota, United States, 55812
University of MN's Tobacco Use Research Center
Minneapolis, Minnesota, United States, 55414
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Dorothy Hatsukami, PhD University of Minnesota - Clinical and Translational Science Institute
  More Information

Publications:
Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01050569     History of Changes
Other Study ID Numbers: 1R01DA025598, R01DA025598, DPMC
Study First Received: January 14, 2010
Results First Received: October 29, 2013
Last Updated: January 14, 2014
Health Authority: United States: Federal Government

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Smoking Cessation
Nicotine Free Cigarettes

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
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014