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Early Effects of a New Oral Nicotine Replacement Product and NiQuitin™ Lozenge

NCT ID: NCT01075659

Last Updated: 2012-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2010-05-31

Brief Summary

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A comparison of two products for oral nicotine replacement with respect to relief of urges to smoke after single doses of nicotine.

Detailed Description

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This study compares a new oral Nicotine Replacement Therapy (NRT) product with NiQuitin™ lozenge 2 mg and 4 mg, respectively, after 5 hours of witnessed nicotine abstinence with respect to urges to smoke during the first 5 minutes after start of treatment. Single doses of each treatment are given during separate treatment visits scheduled in a crossover setting with randomized treatment sequences. The study will include 200 healthy smokers between 19-55 years, who have been smoking at least 10 cigarettes daily during at least one year preceding inclusion, and who smoke within 30 minutes of waking up. Subjects, study personnel and monitor will be aware of what type of product is administered at a given visit, but not of the administered dose of the lozenge.

Conditions

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Smoking Cessation

Keywords

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Smoking Cessation VAS Urges to smoke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LHN1548

Two single doses of an experimental Nicotine Replacement Therapy (NRT) 2 mg, with five hours between treatments. Seven hours duration of total follow-up period.

Group Type EXPERIMENTAL

Nicotine

Intervention Type DRUG

Two single doses of experimental Nicotine Replacement Therapy (NRT) 2 mg, with five hours between treatments. Seven hours duration of total follow-up period

2019706

Two single doses of Nicotine Lozenge 2 mg, with five hours between treatments. Seven hours duration of total follow-up period.

Group Type ACTIVE_COMPARATOR

Nicotine

Intervention Type DRUG

Two single doses of Nicotine Lozenge 2 mg, with five hours between treatments. Seven hours duration of total follow-up period.

2020005

Two single doses of Nicotine Lozenge 4 mg, with five hours between treatments. Seven hours duration of total follow-up period.

Group Type ACTIVE_COMPARATOR

Nicotine

Intervention Type DRUG

Two single doses of Nicotine Lozenge 4 mg, with five hours between treatments. Seven hours duration of total follow-up period.

Interventions

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Nicotine

Two single doses of experimental Nicotine Replacement Therapy (NRT) 2 mg, with five hours between treatments. Seven hours duration of total follow-up period

Intervention Type DRUG

Nicotine

Two single doses of Nicotine Lozenge 2 mg, with five hours between treatments. Seven hours duration of total follow-up period.

Intervention Type DRUG

Nicotine

Two single doses of Nicotine Lozenge 4 mg, with five hours between treatments. Seven hours duration of total follow-up period.

Intervention Type DRUG

Other Intervention Names

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Not yet marketed NiQuitin™ lozenge 2 mg NiQuitinTM lozenge 4 mg

Eligibility Criteria

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Inclusion Criteria

* Healthy smokers, smoking at least 10 cigarettes daily during at least one year preceding inclusion, and smoking within 30 minutes of waking up.
* Female participants of child-bearing potential are required to use a medically acceptable means of birth control.
* A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study.

Exclusion Criteria

* Pregnancy, lactation or intended pregnancy.
* Use of NRT, bupropion, or varenicline, or history of a quit attempt later than 3 months before screening visit.
* Treatment with an investigational product, other than those described in the protocol, between 1 month preceding the first treatment visit and the last treatment visit of the study.
* Prior regular use of any of the investigational products.
Minimum Eligible Age

19 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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McNeil AB

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elisabeth Kruse, PhD

Role: STUDY_DIRECTOR

McNeil AB

Locations

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Clinical Pharmacology

Lund, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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NICTDP2011

Identifier Type: -

Identifier Source: org_study_id