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Phase 2 N=235 Randomized Treatment

Innovative Interventions for Smoking Cessation

Tobacco Use Disorder

Bottom Line

View on ClinicalTrials.gov: NCT01050569 ↗
Enrolled (actual)
235
Serious AEs
0.0%
Results posted
Feb 2014
Primary outcome: Primary: End of Treatment Abstinence Rate — 19; 18; 19 participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Nicotine Patch (Drug); VLNC Cigarette (Other); VLNC Cigarette Plus Nicotine Patch (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of Minnesota
Primary completion
Dec 2011

Outcome Measures

OutcomeResultp-value
PRIMARY
End of Treatment Abstinence Rate		 19; 18; 19 —
PRIMARY
End of Follow-up Abstinence Rates		 14; 15; 15 —
SECONDARY
Exposure to Tobacco Toxicants		 0.40; 0.26; 0.25; 6.89; 27.39; 23.10 —
SECONDARY
Time to Lapse or Relapse to Tobacco Use		 2.6; 7.1; 2.1 —

Summary

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.

Eligibility 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01050569). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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