Phase 2
Completed N=323
Provoked Craving Assessment
Smoking Dependence · Smoking
Source: ClinicalTrials.gov NCT01506908 ↗
Enrolled (actual)
323
Serious AEs
0.0%
Results posted
Jan 2014
Primary outcomePrimary: Change From Post-cue Baseline in Nicotine Craving Score at 5 Minutes — -41.8; -25.9 Score on a scale — p=<0.0001
Summary
Evaluation of the ability of a nicotine mini lozenge to provide early relief of craving for a cigarette in smokers
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Post-cue Baseline in Nicotine Craving Score at 5 Minutes |
-41.8; -25.9 | <0.0001 sig |
| SECONDARY Change From Post-cue Baseline in Nicotine Craving Score at 1 Minute |
-17.2; -12.9 | 0.0511 |
| SECONDARY Change From Post-cue Baseline in Nicotine Craving Score at 3 Minutes |
-31.1; -19.6 | <0.0001 sig |
| SECONDARY Change From Post-cue Baseline in Nicotine Craving Score at 7 Minutes |
-48.2; -30.5 | <0.0001 sig |
| SECONDARY Change From Post-cue Baseline in Nicotine Craving Score at 10 Minutes |
-50.8; -32.9 | <0.0001 sig |
| SECONDARY Number of Participants With Adverse Events (AEs), Treatment Related AEs, and Serious AEs (SAEs) |
12; 54; 11; 54; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Current cigarette smokers who have smoked regularly, and smoke more than 20 cigarettes per day on a regular basis for at least a year;
- Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history.
Exclusion Criteria
- Any disease that may interfere with the absorption, metabolism or excretion of the study product.
- A medical condition that might jeopardise the safety of the subject or the validity of the study results. For example, recent myocardial infarction or cerebrovascular incident (within 12 weeks of the screening visit), phenylketonuria, unstable or worsening angina pectoris, Prinzmetals angina or severe cardiac arrhythmia
Data sourced from ClinicalTrials.gov (NCT01506908). 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.