Clinical trial NCT00313105: 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
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Tobacco Dependence
Keywords: smoking cessation
smokeless tobacco
nicotine patch
nicotine buccal tablets
retreatment
adherence
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
Collaborators: name: Danish Research Foundation, FSS, Copenhagen, Denmark
First posted: 2006-04-11
Enrollment: 600
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Abstinence from smoking after ½ year (point and continuous abstinence)
timeFrame: 6 months from entry
Secondary outcomes:
measure: Adverse events between 3 arms
timeFrame: Up to 6 months from entry
measure: Biomarkers of inhalation between 3 arms (p-cotinine and p-thiocynate and u-NNAL)
timeFrame: 3 and 6 months from entry
measure: Adherence to study
timeFrame: 6,12,24 months from entry
measure: Effect of retreatment (abstinence after 1, 1½ and 2 years)
timeFrame: 12,18 and 24 months from entry
measure: Changes in cholesterol, blood-pressure, lung function, body-weight across smoking status
timeFrame: 6,12,24 months from entry
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Dept. pulmonary medicine Y, Gentofte University Hospital
state: Hellerup
Study officials:
affiliation: Chair dept. pulm. medicine, Gentofte Hospital
name: Philip Tønnesen, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: