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Completed

NCT Number: NCT01466361

Evaluation of the Nicotine Lozenge in Relief of Provoked Acute Craving

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).

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Key information

Conditions

Smoking Behavior Health Behavior Smoking Cessation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Los Angeles Clinical Trials

Burbank, California, 91505, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nicotine lower dose

Drug

lower dose nicotine lozenge

Nicotine higher dose

Drug

higher dose nicotine lozenge

Placebo

Drug

placebo

Primary outcomes

  1. Mean Change From Baseline in Nicotine Cravings VAS Scores in Light Smokers

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

    Participants completed a nicotine craving assessment consisting of following five items: I have a desire for a cigarette right now, if it were possible I would smoke right now, All I want right now is a cigarette, I have an urge for a cigarette, I crave a cigarette right now. All participants indicated their craving intensity on a pre-drawn 100 mm scale ranging from 0 (disagree) to 100 (agree). At the end of the craving assessment period, mean VAS score (in mm) was measured.

  2. Mean Change From Baseline in Nicotine Cravings VAS Scores in Heavy Smokers

    Time frame: Baseline, 3 minutes and 15 minutes post-treatment

    Participants completed a nicotine craving assessment consisting of following five items: I have a desire for a cigarette right now, if it were possible I would smoke right now, All I want right now is a cigarette, I have an urge for a cigarette, I crave a cigarette right now. All participants indicated their craving intensity on a pre-drawn 100 mm scale ranging from 0 (disagree) to 100 (agree). At the end of the craving assessment period, mean VAS score (in mm) was measured.

Secondary outcomes

  1. Percentage of Responders With Improved Craving Scores in Heavy and Light Smokers Group

    Time frame: Baseline prior to provoked craving paradigm, baseline post provoked craving paradigm

    Responders were defined as participants with an increase of at least one point (on the 100 point VAS scale) from baseline prior to provoked craving paradigm (B1) to baseline post provoked craving paradigm (B2) on the average cravings score. Percentage of these responders was calculated to evaluate the provocation rate.

  2. Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)

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

    AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition which does not necessarily have a causal relationship with study treatment/s.

    SAE was defined as any untoward medical occurrence that at any dose results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization results in disability/ incapacity; is a congenital anomaly/ birth defect.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Nov 7, 2011
Registry last updated
Aug 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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