Last updated: 07/17/2024 17:49:56

Evaluation of the nicotine lozenge in relief of provoked acute craving

GSK study ID
S7120994
See study documents
Clinicaltrials.gov ID
NCT01466361
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Evaluation of the nicotine lozenge in relief of provoked acute craving
Trial description: 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).
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Mean change from baseline in nicotine cravings VAS scores in light smokers

Timeframe: Baseline, 1, 3, 5, 10 and 15 minutes post-treatment

Mean change from baseline in nicotine cravings VAS scores in heavy smokers

Timeframe: Baseline, 3 minutes and 15 minutes post-treatment

Secondary outcomes:

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

Number of participants with Adverse Events (AEs) and Serious AEs (SAEs)

Timeframe: Baseline, 0 minute, 60 minutes and 5 days post treatment

Interventions:
  • Drug: Nicotine lower dose
  • Drug: Nicotine higher dose
  • Drug: Placebo
    • Enrollment:
    187
    Primary completion date:
    2010-31-12
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Smoking
    Product
    nicotine
    Collaborators
    Not applicable
    Study date(s)
    September 2010 to December 2010
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • 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
    • 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.
    Inclusion and exclusion 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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    Los Angeles Clinical Trials
    Burbank, CA, United States, 91505
    Status
    Study Complete
    Contact us

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2010-31-12
    Actual study completion date
    2010-31-12

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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