Evaluation of the Nicotine Lozenge in Relief of Provoked Acute Craving

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01466361
First received: November 3, 2011
Last updated: November 8, 2012
Last verified: October 2012
  Purpose

This study is designed to evaluate the ability of a nicotine lozenge to relieve craving for a cigarette compared to a matched placebo (a placebo is like sugar pill and contains no active).


Condition Intervention Phase
Smoking
Smoking Cessation
Drug: Nicotine lower dose
Drug: Nicotine higher dose
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 Lozenge in Relief of Provoked Acute Craving

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Mean Change From Baseline in Nicotine Cravings VAS Scores in Light Smokers [ Time Frame: Baseline, 1, 3, 5, 10 and 15 minutes post-treatment ] [ 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 (in mm) was measured.

  • Mean Change From Baseline in Nicotine Cravings VAS Scores in Heavy Smokers [ Time Frame: Baseline, 3 minutes and 15 minutes post-treatment ] [ 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 (in mm) was measured.


Secondary Outcome Measures:
  • Percentage of Responders With Improved Craving Scores in Heavy and Light Smokers Group [ Time Frame: Baseline prior to provoked craving paradigm, baseline post provoked craving paradigm ] [ Designated as safety issue: No ]
    Responders were defined as participants with an increase of at least one point (on the 100 point VAS scale) from baseline prior to provoked craving paradigm (B1) to baseline post provoked craving paradigm (B2) on the average cravings score. Percentage of these responders was calculated to evaluate the provocation rate.

  • Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) [ Time Frame: Baseline, 0 minute, 60 minutes and 5 days post treatment ] [ 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.

    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: 187
Study Start Date: September 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lower dose Nicotine
lower dose nicotine lozenge
Drug: Nicotine lower dose
lower dose nicotine lozenge
Active Comparator: Higher dose Nicotine
higher dose Nicotine lozenge
Drug: Nicotine higher dose
higher dose nicotine lozenge
Placebo Comparator: Placebo
Placebo
Drug: Placebo
placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Generally healthy smokers who smoke more than 5 cigarettes per day
  • Body mass index (BMI) within the range 19-35 kilogram (kg)/meter (m)^2
  • Females of childbearing potential who are, in the opinion of the investigator, practicing a reliable method of contraception.

Exclusion Criteria:

  • Women who are pregnant or who have a positive urine pregnancy test.
  • Participants with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
  • Clinical Study/Experimental Medication: Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
  • Prior Concomitant Medication: Treatment with enzyme altering agents (e.g. carbamazepine, phenytoin, cimetidine, sodium valporate) within 30 days of the craving provocation visit; Use of any prescription psychoactive medication (such as but not limited to antidepressants, antipsychotics, anxiolytics) within 14 days of the craving provocation visit; Participant has used an over-the-counter (OTC) medication such as antihistamines, sedating agents, or any compound that would have a sedating effect within 24 hours of the craving provocation visit; Current use of any nicotine replacement therapy.
  • Substance abuse: Recent history or current history (within the last 1 year) of alcohol or other substance abuse.
  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: NCT01466361

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: NCT01466361     History of Changes
Other Study ID Numbers: S7120994
Study First Received: November 3, 2011
Results First Received: August 23, 2012
Last Updated: November 8, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Nicotine
Nicotine 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 July 28, 2014