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Smoking Cessation With Smokeless Tobacco, Nicotine Tablets and Nicotine Patches

Primary Purpose

Tobacco Dependence

Status
Unknown status
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Smokeless tobacco (Oliver Twist pellets)
smoking cessation counseling
Sponsored by
University Hospital, Gentofte, Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tobacco Dependence focused on measuring smoking cessation, smokeless tobacco, nicotine patch, nicotine buccal tablets, retreatment, adherence

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Dept. pulmonary medicine Y, Gentofte University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Smokeless Tobacco

Nicotine tablets

3

Arm Description

Smokeless Tobacco and individual visits

Nicotine tablets

7-mg nicotine patch acts as placebo

Outcomes

Primary Outcome Measures

Abstinence from smoking after ½ year (point and continuous abstinence)

Secondary Outcome Measures

Adverse events between 3 arms
Biomarkers of inhalation between 3 arms (p-cotinine and p-thiocynate and u-NNAL)
Adherence to study
Effect of retreatment (abstinence after 1, 1½ and 2 years)
Changes in cholesterol, blood-pressure, lung function, body-weight across smoking status

Full Information

First Posted
April 10, 2006
Last Updated
September 14, 2009
Sponsor
University Hospital, Gentofte, Copenhagen
Collaborators
Danish Research Foundation, FSS, Copenhagen, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT00313105
Brief Title
Smoking Cessation With Smokeless Tobacco, Nicotine Tablets and Nicotine Patches
Official Title
Smoking Cessation by Nurses With Smokeless Tobacco Buccal Tablets, Nicotine Buccal Tablets, Nicotine Patches With Repeated Therapy Every 6 Months for 2 Years
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Unknown status
Study Start Date
April 2006 (undefined)
Primary Completion Date
April 2010 (Anticipated)
Study Completion Date
August 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Gentofte, Copenhagen
Collaborators
Danish Research Foundation, FSS, Copenhagen, Denmark

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Dependence
Keywords
smoking cessation, smokeless tobacco, nicotine patch, nicotine buccal tablets, retreatment, adherence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Smokeless Tobacco
Arm Type
Experimental
Arm Description
Smokeless Tobacco and individual visits
Arm Title
Nicotine tablets
Arm Type
Active Comparator
Arm Description
Nicotine tablets
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
7-mg nicotine patch acts as placebo
Intervention Type
Drug
Intervention Name(s)
Smokeless tobacco (Oliver Twist pellets)
Intervention Description
individual visits with counseling
Intervention Type
Behavioral
Intervention Name(s)
smoking cessation counseling
Intervention Description
individual visits
Primary Outcome Measure Information:
Title
Abstinence from smoking after ½ year (point and continuous abstinence)
Time Frame
6 months from entry
Secondary Outcome Measure Information:
Title
Adverse events between 3 arms
Time Frame
Up to 6 months from entry
Title
Biomarkers of inhalation between 3 arms (p-cotinine and p-thiocynate and u-NNAL)
Time Frame
3 and 6 months from entry
Title
Adherence to study
Time Frame
6,12,24 months from entry
Title
Effect of retreatment (abstinence after 1, 1½ and 2 years)
Time Frame
12,18 and 24 months from entry
Title
Changes in cholesterol, blood-pressure, lung function, body-weight across smoking status
Time Frame
6,12,24 months from entry

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Tønnesen, M.D., Ph.D.
Organizational Affiliation
Chair dept. pulm. medicine, Gentofte Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. pulmonary medicine Y, Gentofte University Hospital
City
Copenhagen
State/Province
Hellerup
ZIP/Postal Code
2900
Country
Denmark

12. IPD Sharing Statement

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Smoking Cessation With Smokeless Tobacco, Nicotine Tablets and Nicotine Patches

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