Efficacy and Safety Following Use of a Novel Nicotine Replacement Therapy

NCT00882375 | Completed

• 2 other identifiers: A64311112008-006845-13
• Study Type: interventional
• Target: 479
• Locations: 2 countries
• Sites: 3

Brief Summary

A comparison of a novel nicotine replacement therapy and placebo treatment in smokers motivated to quit smoking.

Conditions

Smoking Cessation

Keywords

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

• Self-reported continuous abstinence from smoking verified by exhaled CO levels of less than 10 ppm.

  at weeks 2, 6, 24 and 52

Secondary Outcomes (5)

• Self-reported continuous abstinence from smoking, verified by exhaled CO levels of less than 10 ppm.

  weeks 2, 4, 8, 12, 16, and 20

• Self-reported 7-day point prevalence abstinence from smoking verified by exhaled CO levels of less than 10 ppm.

  weeks 4, 6, 8, 12, 16, 20, 24, and 52

• Ratings of craving/urge to smoke and withdrawal symptoms.

  baseline to 24 weeks

• Cotinine levels in saliva.

  baseline, and weeks 2, 6, 12 and 24

• Product acceptability

  weeks 1, 6 and 12

Study Arms (2)

Nicotine

EXPERIMENTAL

Nicotine

Drug: Nicotine

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Nicotine DRUG

Nicotine administered using novel NRT user instructions

Also known as: NRT

Nicotine

Placebo DRUG

Placebo administered using novel NRT user instructions

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older male and female cigarette smokers motivated and willing to stop smoking
• Female participants of child-bearing potential should use a medically acceptable means of birth control.
• Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study and consents to participate.

You may not qualify if:

• Unstable angina pectoris or myocardial infarction during the previous 3 months.
• Pregnancy, lactation or intended pregnancy (non-pregnancy will be verified by urine pregnancy test for female participants of child-bearing potential).
• Participation in other clinical trials within the previous three months and during study participation.

Sponsors & Collaborators

• McNeil AB: lead

Study Sites (3)

Gentofte University Hospital

Hellerup, 2900, Denmark

Location

University of Heidelberg

Mannheim, 68159, Germany

Location

University Hospital of Tuebingen

Tübingen, 72076, Germany

Location

Related Publications (1)

• Roche F, Pepin JL, Achour-Crawford E, Tamisier R, Pichot V, Celle S, Maudoux D, Chouchou F, Ntougou-Assoumou HG, Levy P, Barthelemy JC; PROOF Study Group. At 68 years, unrecognised sleep apnoea is associated with elevated ambulatory blood pressure. Eur Respir J. 2012 Sep;40(3):649-56. doi: 10.1183/09031936.00162710. Epub 2012 Apr 20.

  PMID: 22523363 DERIVED

MeSH Terms

Conditions

Smoking Cessation

Interventions

Nicotine

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Elisabeth Kruse, PhD

  McNeil AB

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2009
• First Posted: April 16, 2009
• Study Start: March 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: July 2, 2012

Record last verified: 2012-06

Locations

DK (1); DE (2)