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Provoked Craving Assessment

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01506908
First Posted: January 10, 2012
Last Update Posted: March 12, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose
Evaluation of the ability of a nicotine mini lozenge to provide early relief of craving for a cigarette in smokers

Condition Intervention Phase
Smoking Dependence Smoking Drug: oral nicotine Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of the Nicotine Mini Lozenge in Relief of Provoked Acute Craving

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.

  • 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.

  • 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.

  • 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.

  • 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.


Enrollment: 323
Study Start Date: September 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Nicotine Polacrilex mint mini lozenge Drug: oral nicotine
oral nicotine replacement product
Placebo Comparator: placebo
mint mini lozenge with no active
Drug: Placebo
no active

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01506908


Locations
United States, California
Los Angeles Clinical Trials
Burbank, California, United States, 91505
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01506908     History of Changes
Other Study ID Numbers: S7121359
First Submitted: December 15, 2011
First Posted: January 10, 2012
Results First Submitted: December 12, 2013
Results First Posted: January 30, 2014
Last Update Posted: March 12, 2014
Last Verified: December 2013

Keywords provided by GlaxoSmithKline:
craving

Additional relevant MeSH terms:
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action


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