Nicotine Mouth Film for Craving Relief.

NCT01702532 | Completed Phase 3 Results

• 1 other identifier: RH01589
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 2

Brief Summary

Nicotine mouth film is a new dosage form of nicotine replacement therapy. The purpose of this study is to investigate the craving relief efficacy of nicotine mouth film by comparing mint nicotine mouth film to nicotine lozenge in light smokers using the provoked craving model. The cues used to provoke a craving episode will be the sight and smell of a lit cigarette and the manipulations required to light a cigarette. The smokers will be denied access to cigarettes for 4 hours prior to the provoked craving session in order to precipitate nicotine withdrawal and an increase level of cigarette craving.

Conditions

Smoking Cessation

Keywords

provoked craving

Outcome Measures

Primary Outcomes (1)

• The Change From Pre-dose Post-provocation in Craving Score at 50 Seconds

  Participants completed a cigarette craving assessment consisting of the 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 craving intensity on a pre-drawn 100 millimeter (mm) Visual Analog Scale (VAS) ranging from 0 (disagree) to 100 (agree). The average of the scores over the five items was defined as craving score for each time point.

  Pre-dosing post-provocation to 50 seconds

Secondary Outcomes (1)

• The Change From Pre-dose Post-provocation in Craving Score at 3, 5, 7, 10, 15, 20, 25, and 30 Minutes

  Pre-dosing post-provocation to 3, 5, 7, 10, 15, 20, 25, and 30 minutes

Study Arms (2)

Nicotine Mouth Film

EXPERIMENTAL

mint nicotine mouth film, buccal administration

Drug: Nicotine

Nicotine Lozenge

ACTIVE COMPARATOR

nicotine lozenge, buccal administration

Drug: Nicotine

Interventions

Nicotine DRUG

Comparison of different dosage forms of nicotine

Nicotine Lozenge; Nicotine Mouth Film

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI within the range of 19-35 kg/m2;
• Current cigarette smokers who have smoked regularly daily for at least a year,
• Participants who smoke their first cigarette more than 30 minutes after waking up

You may not qualify if:

• Known or suspected intolerance or hypersensitivity to nicotine (or closely related compounds) or any of the stated ingredients in formulation.
• Any participant whose CO level rises during the sequestration period (i.e., the subject's two 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (2)

Los Angeles Clinical Trials

Burbank, California, 91505, United States

Location

Central Kentucky Research Associates, Inc.

Lexington, Kentucky, 40509, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Interventions

Nicotine

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2012
• First Posted: October 8, 2012
• Study Start: September 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 30, 2014
• Results First Posted: January 30, 2014

Record last verified: 2013-01

Locations

US (2)