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Completed

NCT Number: NCT01506908

Provoked Craving Assessment

Evaluation of the ability of a nicotine mini lozenge to provide early relief of craving for a cigarette in smokers

Completed

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Key information

Conditions

Smoking Dependence Behavior Smoking

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: Yes

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

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

Treatment and study plan

Oral Nicotine

Drug

oral nicotine replacement product

Placebo

Drug

no active

Primary outcomes

  1. Change From Post-cue Baseline in Nicotine Craving Score at 5 Minutes

    Time frame: Post-cue baseline,5 minutes

    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 was measured.

Secondary outcomes

  1. Change From Post-cue Baseline in Nicotine Craving Score at 1 Minute

    Time frame: Post-cue baseline, 1 minute post treatment administration

    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 was measured.

  2. Change From Post-cue Baseline in Nicotine Craving Score at 3 Minutes

    Time frame: Post-cue Baseline, 3 minutes post treatment administration

    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 was measured.

  3. Change From Post-cue Baseline in Nicotine Craving Score at 7 Minutes

    Time frame: Post-Cue Baseline, 7 minutes post treatment administration

    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 was measured.

  4. Change From Post-cue Baseline in Nicotine Craving Score at 10 Minutes

    Time frame: Post-Cue Baseline, 10 minutes post treatment administration

    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 was measured.

  5. Number of Participants With Adverse Events (AEs), Treatment Related AEs, and Serious AEs (SAEs)

    Time frame: Baseline to Day 5 post treatment administration

    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. Treatment related AE was defined as any AE considered to be possibly, probably or highly probably related to study medication. 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

Official study title

Evaluation of the Nicotine Mini Lozenge in Relief of Provoked Acute Craving

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jan 10, 2012
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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