The Efficacy of Acetium Lozenges in Intervention for Smoking Cessation
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|ClinicalTrials.gov Identifier: NCT02758743|
Recruitment Status : Completed
First Posted : May 2, 2016
Last Update Posted : June 23, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Smoking Cessation||Drug: Acetium Lozenge Drug: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1998 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Efficacy of Acetium Lozenges in Intervention for Smoking Cessation: A Double-blind, Placebo-controlled Trial|
|Study Start Date :||April 2016|
|Actual Primary Completion Date :||May 2017|
|Actual Study Completion Date :||May 2017|
Experimental: Acetium Lozenge
Acetium lozenge (L-cysteine 3mg) is used in context of each cigarette smoked.
Drug: Acetium Lozenge
Slow-release L-Cysteine to block smoke.derived acetaldehyde in saliva thereby inhibiting the formation of harmans
Placebo Comparator: Placebo
Identical in appearance with Acetium lozenge, placebo lozenges will be used in the same manner as in experimental arm.
Placebo with no active substance will not have the effect on intervention device.
- Prolonged abstinence (PA), based on smoking diary [ Time Frame: 6 months ]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
- Point prevalence of abstinence (PPA), based on smoking diary [ Time Frame: 6 months ]Point prevalence is typically defined as not smoking on the day of follow-up (or for a few days before a follow-up day).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02758743
|Principal Investigator:||Kari Syrjänen, MD, PhD||Biohit Oyj|