Phase 2
Completed N=187
Evaluation of the Nicotine Lozenge in Relief of Provoked Acute Craving
Source: ClinicalTrials.gov NCT01466361 ↗Enrolled (actual)
187
Serious AEs
0.0%
Results posted
Dec 2012
Primary outcomePrimary: Mean Change From Baseline in Nicotine Cravings VAS Scores in Light Smokers — -15.40; -8.17; -24.42; -17.26 Score on a scale — p=0.0643
Summary
This study is designed to evaluate the ability of a nicotine lozenge to relieve craving for a cigarette compared to a matched placebo (a placebo is like sugar pill and contains no active).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Nicotine Cravings VAS Scores in Light Smokers |
-15.40; -8.17; -24.42; -17.26; -30.19; -23.86 | 0.0643 |
| PRIMARY Mean Change From Baseline in Nicotine Cravings VAS Scores in Heavy Smokers |
-16.82; -13.24; -29.52; -19.82 | 0.3922 |
| SECONDARY Percentage of Responders With Improved Craving Scores in Heavy and Light Smokers Group |
77.2; 75.6 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) |
11; 0; 1; 1; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Generally healthy smokers who smoke more than 5 cigarettes per day
- Body mass index (BMI) within the range 19-35 kilogram (kg)/meter (m)^2
- Females of childbearing potential who are, in the opinion of the investigator, practicing a reliable method of contraception.
Exclusion Criteria
- Women who are pregnant or who have a positive urine pregnancy test.
- Participants with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- Clinical Study/Experimental Medication: Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
- Prior Concomitant Medication: Treatment with enzyme altering agents (e.g. carbamazepine, phenytoin, cimetidine, sodium valporate) within 30 days of the craving provocation visit; Use of any prescription psychoactive medication (such as but not limited to antidepressants, antipsychotics, anxiolytics) within 14 days of the craving provocation visit; Participant has used an over-the-counter (OTC) medication such as antihistamines, sedating agents, or any compound that would have a sedating effect within 24 hours of the craving provocation visit; Current use of any nicotine replacement therapy.
- Substance abuse: Recent history or current history (within the last 1 year) of alcohol or other substance abuse.
Data sourced from ClinicalTrials.gov (NCT01466361). 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.