Smoking Cessation With Smokeless Tobacco, Nicotine Tablets and Nicotine Patches

September 14, 2009 updated by: University Hospital, Gentofte, Copenhagen

Smoking Cessation by Nurses With Smokeless Tobacco Buccal Tablets, Nicotine Buccal Tablets, Nicotine Patches With Repeated Therapy Every 6 Months for 2 Years

To test if smokeless tobacco is more effective than nicotine buccal tablets in smoking cessation compared with a control group with low dose nicotine patches.

Also retreatment will be tested with smokeless tobacco every 6 months in failures for 1½ year. Adherence to the program will be enhanced by assessment of cholesterol, blood pressure, lung function and body weight every 6 months for 2 years.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This is an open randomized controlled trial with 3 groups testing smokeless tobacco in smoking cessation: 200 smokers will get smokeless tobacco for 3 months, 200 will get nicotine buccal tablets for 3 months and 200 will get 7-mg nicotine patches for 3 months (control arm). After ½, 1 and 1½ a year failures will get smokeless tobacco in the first 2 groups, while only 7 mg nicotine patches in control group until 1½ year where failures in this group also will get smokeless tobacco. Every ½ year cholesterol, blood pressure, lung function and BMI will be assessed and used to enhance adherence of the participants in this trial.

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Hellerup
      • Copenhagen, Hellerup, Denmark, 2900
        • Dept. pulmonary medicine Y, Gentofte University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • smokers (>7 cig/day)
  • Healthy
  • Allowed: treated hypertension, diabetes treated with tablets, increased cholesterol,other "mild" diseases
  • mild asthma and COPD,
  • Motivated to quit smoking
  • Motivated to follow the protocol
  • Motivated to use medication in this trial

Exclusion Criteria:

  • Severe diseases
  • Psychiatric diseases
  • Used NRT or Zyban the last 2 weeks
  • Stopped smoking >2 days during last 3 months
  • More than 6 alcoholic drinks per day
  • Smokes other products than cigarettes
  • Pregnant of lactating

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Smokeless Tobacco
Smokeless Tobacco and individual visits
Drug: Smokeless tobacco (Oliver Twist pellets)
individual visits with counseling
Behavioral: smoking cessation counseling
individual visits
Active Comparator: Nicotine tablets
Behavioral: smoking cessation counseling
individual visits
Placebo Comparator: 3
7-mg nicotine patch acts as placebo
Behavioral: smoking cessation counseling
individual visits

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Abstinence from smoking after ½ year (point and continuous abstinence)
Time Frame: 6 months from entry
6 months from entry

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events between 3 arms
Time Frame: Up to 6 months from entry
Up to 6 months from entry
Biomarkers of inhalation between 3 arms (p-cotinine and p-thiocynate and u-NNAL)
Time Frame: 3 and 6 months from entry
3 and 6 months from entry
Adherence to study
Time Frame: 6,12,24 months from entry
6,12,24 months from entry
Effect of retreatment (abstinence after 1, 1½ and 2 years)
Time Frame: 12,18 and 24 months from entry
12,18 and 24 months from entry
Changes in cholesterol, blood-pressure, lung function, body-weight across smoking status
Time Frame: 6,12,24 months from entry
6,12,24 months from entry

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Gentofte, Copenhagen

Collaborators

Danish Research Foundation, FSS, Copenhagen, Denmark

Investigators

  • Principal Investigator: Philip Tønnesen, M.D., Ph.D., Chair dept. pulm. medicine, Gentofte Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Anticipated)

April 1, 2010

Study Completion (Anticipated)

August 1, 2010

Study Registration Dates

First Submitted

April 10, 2006

First Submitted That Met QC Criteria

April 10, 2006

First Posted (Estimate)

April 11, 2006

Study Record Updates

Last Update Posted (Estimate)

September 15, 2009

Last Update Submitted That Met QC Criteria

September 14, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005-004626-10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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