Provoked Craving Assessment

NCT01506908 | Completed Phase 2 Results

• 1 other identifier: S7121359
• Study Type: interventional
• Target: 323
• Locations: 1 country
• Sites: 1

Brief Summary

Evaluation of the ability of a nicotine mini lozenge to provide early relief of craving for a cigarette in smokers

Conditions

Smoking Dependence; Smoking

Keywords

craving

Outcome Measures

Primary Outcomes (1)

• Change From Post-cue Baseline in Nicotine Craving Score at 5 Minutes

  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.

  Post-cue baseline,5 minutes

Secondary Outcomes (5)

• Change From Post-cue Baseline in Nicotine Craving Score at 1 Minute

  Post-cue baseline, 1 minute post treatment administration

• Change From Post-cue Baseline in Nicotine Craving Score at 3 Minutes

  Post-cue Baseline, 3 minutes post treatment administration

• Change From Post-cue Baseline in Nicotine Craving Score at 7 Minutes

  Post-Cue Baseline, 7 minutes post treatment administration

• Change From Post-cue Baseline in Nicotine Craving Score at 10 Minutes

  Post-Cue Baseline, 10 minutes post treatment administration

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

  Baseline to Day 5 post treatment administration

Study Arms (2)

Nicotine Polacrilex mint mini lozenge

ACTIVE COMPARATOR

Drug: oral nicotine

placebo

PLACEBO COMPARATOR

mint mini lozenge with no active

Drug: Placebo

Interventions

oral nicotine DRUG

oral nicotine replacement product

Nicotine Polacrilex mint mini lozenge

Placebo DRUG

no active

placebo

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

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

Interventions

Nicotine

Condition Hierarchy (Ancestors)

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: December 15, 2011
• First Posted: January 10, 2012
• Study Start: September 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: August 28, 2019
• Results First Posted: January 30, 2014

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)