Phase 2
Completed N=235
Innovative Interventions for Smoking Cessation
Source: ClinicalTrials.gov NCT01050569 ↗Enrolled (actual)
235
Serious AEs
0.0%
Results posted
Feb 2014
Primary outcomePrimary: End of Treatment Abstinence Rate — 19; 18; 19 participants
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.
Outcome Measures
| Outcome | Result | p-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 | — |
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.
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. Informational only — not medical advice.