Smoking Cessation With Smokeless Tobacco, Nicotine Tablets and Nicotine Patches

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

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00313105

Enrollment

600

Registered

2006-04-11

Start date

2006-04-30

Completion date

2010-08-31

Last updated

2009-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tobacco Dependence

Keywords

smoking cessation, smokeless tobacco, nicotine patch, nicotine buccal tablets, retreatment, adherence

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.

Interventions

DRUGSmokeless tobacco (Oliver Twist pellets)

individual visits with counseling

BEHAVIORALsmoking cessation counseling

individual visits

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

25 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026