Smoking Cessation Clinical Trial
Official title:
The Efficacy of Acetium Lozenges in Intervention for Smoking Cessation: A Double-blind, Placebo-controlled Trial
Verified date | June 2017 |
Source | Biohit Oyj |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to validate the novel hypothesis that regular use of Acetium
Lozenge is promising novel method to assist in smoking cessation.
The aim of this confirmatory study is to affirm the promising results obtained in a previous
smoking intervention trial with Acetium lozenge. If successful, the trial gives adequate
power to confirm, that the Acetium lozenge represents a breakthrough in the development of
smoking intervention methods.
Status | Completed |
Enrollment | 1998 |
Est. completion date | May 2017 |
Est. primary completion date | May 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - 18-65 years male/female - current cigarette smoker - motivated to quit smoking Exclusion Criteria: - serious smoking-related diseases - pregnant and lactating women - use of quit smoking medicine - simultaneous participation in an other clinical trial - earlier participation in the same trial |
Country | Name | City | State |
---|---|---|---|
Finland | Kuulas Helsinki | Helsinki |
Lead Sponsor | Collaborator |
---|---|
Biohit Oyj |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Prolonged abstinence (PA), based on smoking diary | Prolonged abstinence, a sustained or continuous abstinence - is typically defined as not smoking for a period of several months after a quit attempt. Sometimes, this is for the entire period since the quit date, and sometimes it begins after an initial "grace or charm" period | 6 months | |
Primary | Point prevalence of abstinence (PPA), based on smoking diary | Point prevalence is typically defined as not smoking on the day of follow-up (or for a few days before a follow-up day). | 6 months |
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