Provoked Craving Relief Study by NRT

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01476202
First received: November 17, 2011
Last updated: July 30, 2013
Last verified: April 2012
  Purpose

This study is designed to assess the ability of the mint nicotine mouth strip to relieve provoked cigarette craving in light smokers compared to nicotine lozenge and nicotine gum.


Condition Intervention Phase
Smoking Cessation
Drug: nicotine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study to Evaluate Relief of Provoked Acute Craving by Nicotine Mouth Strip, Nicorette ® Nicotine Lozenge and Gum

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Mean Change From Baseline in Nicotine Craving Score on a VAS [ Time Frame: Baseline, 50 seconds, 3, 5, 7, 10, 15, 20, 25 and 30 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.


Secondary Outcome Measures:
  • Log Transformed Area Under the Curve of Nicotine Craving Score (AUC) [ Time Frame: Baseline, 50 seconds, 3, 5, 7, 10, 15, 20, 25, and 30 minutes post treatment administration ] [ Designated as safety issue: No ]
    AUC between the baseline (pre-dose) and the time of measurement of craving on-treatment was determined.


Enrollment: 120
Study Start Date: November 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nicotine mouth strip
single dose
Drug: nicotine
nicotine in the form of a mouth strip, lozenge and gum
Active Comparator: nicotine lozenge
single dose
Drug: nicotine
nicotine in the form of a mouth strip, lozenge and gum
Active Comparator: nicotine gum
single dose
Drug: nicotine
nicotine in the form of a mouth strip, lozenge and gum

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Smoking Status: Current cigarette smokers who have smoked regularly for at least a year and smoke their first cigarette more than 30 minutes after waking up.

Exclusion Criteria:

  • Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to nicotine (or closely related compounds) or any of the stated ingredients in formulation.
  • Prior Concomitant Medication: a. Treatment with known enzyme altering agents (e.g. carbamazepine, phenytoin, cimetidine, sodium valporate) within 30 days of the craving provocation visit. b. Use of any prescription psychoactive medication (such as but not limited to antidepressants, antipsychotics, anxiolytics) within 14 days of the craving provocation visit. c. Use of any over-the-counter (OTC) medication that affects central nervous system such as antihistamines, sedating agents, or any compound that would have a sedating effect within 24 hours of the craving provocation visit. d. Use of any nicotine replacement therapy or any other treatment for smoking cessation (e.g. bupropion or varenicline) within one month of screening visit. e. Use of any nicotine containing products at any time during the Provocation/Treatment visit. f. Use of any medications noted in the exclusion criteria, or use of any product that would, in the opinion of the investigator, jeopardize the safety of the subject or impact on the validity of the study results.
  • Any disease that, in the opinion of the investigator, may interfere with the absorption, metabolism or excretion of the study product. A medical history that, in the opinion of the investigator, might jeopardise the safety of the subject or the validity of the study results. For example, recent myocardial infarction or cerebrovascular accident (within 12 weeks of the screening visit), phenylketonuria, unstable or worsening angina pectoris, Prinzmetals angina or severe cardiac arrhythmia.
  • Expired Carbon Monoxide (CO): Any subject whose CO level rises during the sequestration period (i.e., the subject's expired CO assessments immediately prior to the provoked craving paradigm are higher than the mean baseline CO assessment) and, in the opinion of the investigator, may have smoked during that time.
  • Alcohol: Consumption of any alcoholic beverage within 24 hours of the craving provocation visit, as indicated by a positive breath alcohol test.
  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: NCT01476202

Locations
United States, Kentucky
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, United States, 40509
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01476202     History of Changes
Other Study ID Numbers: S2111378
Study First Received: November 17, 2011
Results First Received: July 30, 2013
Last Updated: July 30, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
craving, provoked craving, smoking cessation, nicotine replacement therapy, NRT

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

ClinicalTrials.gov processed this record on October 23, 2014