NCT01506908 - Provoked Craving Assessment | Crick

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

323

Conditions

Smoking Dependence Smoking

Interventions

oral nicotineDRUG

oral nicotine replacement product

PlaceboDRUG

no active

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Los Angeles Clinical Trials

Burbank, California, United States

Outcomes

Primary Outcomes

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.

Time frame: Post-cue baseline,5 minutes

Secondary Outcomes

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

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.

Time frame: Post-cue baseline, 1 minute post treatment administration

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

Time frame: Post-cue Baseline, 3 minutes post treatment administration

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