Smoking Cessation With Smokeless Tobacco, Nicotine Tablets and Nicotine Patches

Tobacco Dependence Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00313105
• Other study ID #: 2005-004626-10
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• First received: April 10, 2006
• Last updated: September 14, 2009
• Start date: April 2006
• Est. completion date: August 2010

Study information

• Verified date: September 2009
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 600
• Est. completion date: August 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tobacco Dependence

Intervention

Drug:
• Smokeless tobacco (Oliver Twist pellets)
individual visits with counseling

Behavioral:
• smoking cessation counseling
individual visits

Locations

Country	Name	City	State
Denmark	Dept. pulmonary medicine Y, Gentofte University Hospital	Copenhagen	Hellerup

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Gentofte, Copenhagen	Danish Research Foundation, FSS, Copenhagen, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abstinence from smoking after ½ year (point and continuous abstinence)		6 months from entry	No
Secondary	Adverse events between 3 arms		Up to 6 months from entry	Yes
Secondary	Biomarkers of inhalation between 3 arms (p-cotinine and p-thiocynate and u-NNAL)		3 and 6 months from entry	Yes
Secondary	Adherence to study		6,12,24 months from entry	No
Secondary	Effect of retreatment (abstinence after 1, 1½ and 2 years)		12,18 and 24 months from entry	No
Secondary	Changes in cholesterol, blood-pressure, lung function, body-weight across smoking status		6,12,24 months from entry	Yes