Provoked Craving Assessment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01506908
First received: December 15, 2011
Last updated: February 6, 2014
Last verified: December 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01506908     History of Changes
Other Study ID Numbers: S7121359
Study First Received: December 15, 2011
Results First Received: December 12, 2013
Last Updated: February 6, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
craving

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

ClinicalTrials.gov processed this record on October 01, 2014