Provoked Craving Assessment

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

323 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2011-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of the Nicotine Lozenge in Relief of Provoked Acute Craving

NCT01466361

Smoking Smoking Cessation

COMPLETED PHASE2

Provoked Craving Relief Study by NRT

NCT01476202

Smoking Cessation

COMPLETED PHASE2

Nicotine Mouth Film for Craving Relief.

NCT01702532

Smoking Cessation

COMPLETED PHASE3

Oral Tolerability Of Two Nicotine Dosage Forms

NCT00682461

Healthy Volunteer Smokers

COMPLETED PHASE1

A Bioequivalence Study of Two Nicotine Lozenges in Fasting Conditions in Healthy Smokers

NCT03541044

Tobacco Use Disorder

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Smoking Dependence Smoking

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Nicotine Polacrilex mint mini lozenge

Group Type ACTIVE_COMPARATOR

oral nicotine

Intervention Type DRUG

oral nicotine replacement product

placebo

mint mini lozenge with no active

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

no active

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

oral nicotine

oral nicotine replacement product

Intervention Type DRUG

Placebo

no active

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes