Smoking Reduction or Cessation With Nicotine Replacement Therapy

Smoking Reduction or Cessation With Nicotine Replacement Therapy. A Placebo Controlled Double Blind Trial With Nicotine Gum or Inhaler.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00840242

Enrollment

314

Registered

2009-02-10

Start date

1999-02-28

Completion date

2000-05-31

Last updated

2012-04-25

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

Conditions

Smoking Cessation

Brief summary

The purpose of this study is to test the success rate of smoking reduction or cessation with different nicotine products.

Detailed description

To test if smoking reduction or cessation is induced with different nicotine products and to investigate the possible health benefits of smoking reduction

Interventions

DRUGNicotine gum

8-12 pieces per day, maximum 24 daily

DRUGPlacebo gum

8-12 pieces per day, maximum 24 daily

DRUGNicotine inhaler

6-12 cartridges per day, maximum 12 daily

DRUGPlacebo inhaler

6-12 cartridges per day, maximum 12 daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age above 18 * Smoking \>/= 15 cigarettes/day * Having smoked for 3 years or more * CO \>/= 10ppm at inclusion * Want to reduce smoking * Prepared to adhere to the protocol * Willing to provide signed informed consent * Having made at least one serious attempt to quit smoking

Exclusion criteria

* Unstable angina pectoris, myocardial infarction within the last three months * Use of other nicotine-containing products such as cigars, pipes, snuff * Current use of NRT or involved in behavioral or pharmacological smoking cessation/reduction program * Pregnancy/lactation or intended pregnancy * Under psychiatric care or medication that might interfere with the trial * Abuse of alcohol or any other drug

Design outcomes

Primary

Measure	Time frame
Reduction in number of smoked cigarettes/day verified by carbon monoxide (CO) levels	Baseline to 6 weeks, 3 and 4 months

Secondary

Measure	Time frame
Changes in laboratory values of cardiovascular risk factors	Baseline up to 12 months
Changes in clinical and laboratory exposure parameters	Baseline up to 12 months

Countries

Czechia

Outcome results

None listed

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