Evaluation of the Nicotine Lozenge in Relief of Provoked Acute Craving

NCT01466361 | Completed Phase 2 Results

• 1 other identifier: S7120994
• Study Type: interventional
• Target: 187
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Smoking; Smoking Cessation

Keywords

Nicotine; Nicotine craving

Outcome Measures

Primary Outcomes (2)

• Mean Change From Baseline in Nicotine Cravings VAS Scores in Light Smokers

  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.

  Baseline, 1, 3, 5, 10 and 15 minutes post-treatment

• Mean Change From Baseline in Nicotine Cravings VAS Scores in Heavy Smokers

  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.

  Baseline, 3 minutes and 15 minutes post-treatment

Secondary Outcomes (2)

• Percentage of Responders With Improved Craving Scores in Heavy and Light Smokers Group

  Baseline prior to provoked craving paradigm, baseline post provoked craving paradigm

• Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)

  Baseline, 0 minute, 60 minutes and 5 days post treatment

Study Arms (3)

Lower dose Nicotine

ACTIVE COMPARATOR

lower dose nicotine lozenge

Drug: Nicotine lower dose

Higher dose Nicotine

ACTIVE COMPARATOR

higher dose Nicotine lozenge

Drug: Nicotine higher dose

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Nicotine lower dose DRUG

lower dose nicotine lozenge

Lower dose Nicotine

Nicotine higher dose DRUG

higher dose nicotine lozenge

Higher dose Nicotine

Placebo DRUG

placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

Los Angeles Clinical Trials

Burbank, California, 91505, United States

Location

Related Publications (1)

• Nides M, Shanga GM, Bishop A, Becker WD. Nicotine Lozenges in the Relief of Behaviorally Provoked Craving. Am J Health Behav. 2018 May 1;42(3):69-80. doi: 10.5993/AJHB.42.3.7.

  PMID: 29663982 DERIVED

MeSH Terms

Conditions

Smoking; Smoking Cessation

Interventions

Nicotine

Condition Hierarchy (Ancestors)

Behavior; Health 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 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2011
• First Posted: November 7, 2011
• Study Start: September 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: August 28, 2019
• Results First Posted: December 4, 2012

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
• Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Locations

US (1)