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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: March 8, 2012
Last verified: March 2012
History of Changes
  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:

MedlinePlus related topics: Smoking
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • average score [ Time Frame: during Visit 2, 5 minutes post dosing ] [ Designated as safety issue: No ]
    VAS Craving Assessment


Secondary Outcome Measures:
  • assess the incidence and severity of adverse events [ Time Frame: from the start of the smoking abstinence sequestration period and until 5 days following last administration of the investigational product ] [ Designated as safety issue: Yes ]
    To assess the incidence and severity of adverse events

  • average score [ Time Frame: during Visit 2, 5 minutes post dosing ] [ Designated as safety issue: No ]
    VAS Craving Assessment at 1, 3, 7 and 10 minutes post dosing


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
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
Last Updated: March 8, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
craving

Additional relevant MeSH terms:
Smoking
Habits
Nicotine
Nicotine polacrilex
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
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 13, 2013