Provoked Craving Assessment

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Smoking Dependence; Smoking

Treatments: Drug: Placebo; Drug: oral nicotine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01506908

S7121359

Details and patient eligibility

About

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

Enrollment: 323 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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323 participants in 2 patient groups, including a placebo group

Nicotine Polacrilex mint mini lozenge

Active Comparator group

Treatment:

Drug: oral nicotine

placebo

Placebo Comparator group

Description:

mint mini lozenge with no active

Treatment:

Drug: Placebo