Clinical trial NCT01466361: Evaluation of the Nicotine Lozenge in Relief of Provoked Acute Craving
Official title: Evaluation of the Nicotine Lozenge in Relief of Provoked Acute Craving
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Smoking
Smoking Cessation
Keywords: Nicotine
Nicotine craving
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2011-11-06
Enrollment: 187
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


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.

Primary outcomes:
measure: Mean Change From Baseline in Nicotine Cravings VAS Scores in Light Smokers
timeFrame: Baseline, 1, 3, 5, 10 and 15 minutes post-treatment
measure: Mean Change From Baseline in Nicotine Cravings VAS Scores in Heavy Smokers
timeFrame: Baseline, 3 minutes and 15 minutes post-treatment
Secondary outcomes:
measure: Percentage of Responders With Improved Craving Scores in Heavy and Light Smokers Group
timeFrame: Baseline prior to provoked craving paradigm, baseline post provoked craving paradigm
measure: Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
timeFrame: Baseline, 0 minute, 60 minutes and 5 days post treatment
Other outcomes:
Locations:
city: Burbank
country: United States
facility: Los Angeles Clinical Trials
state: California
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Nides M, Shanga GM, Bishop A, Becker WD. Nicotine Lozenges in the Relief of Behaviorally Provoked Craving. Am J Health Behav. 2018 May 1;42(3):69-80. doi: 10.5993/AJHB.42.3.7.