We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Efficacy of Acetium Lozenges in Intervention for Smoking Cessation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02758743
Recruitment Status : Completed
First Posted : May 2, 2016
Last Update Posted : June 23, 2017
Sponsor:
Information provided by (Responsible Party):
Biohit Oyj

Brief Summary:

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

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1998 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: Placebo
Placebo with no active substance will not have the effect on intervention device.




Primary Outcome Measures :
  1. 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

  2. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Locations
Layout table for location information
Finland
Kuulas Helsinki
Helsinki, Finland
Sponsors and Collaborators
Biohit Oyj
Investigators
Layout table for investigator information
Principal Investigator: Kari Syrjänen, MD, PhD Biohit Oyj
Layout table for additonal information
Responsible Party: Biohit Oyj
ClinicalTrials.gov Identifier: NCT02758743    
Other Study ID Numbers: AL-SMOQUIT-2
First Posted: May 2, 2016    Key Record Dates
Last Update Posted: June 23, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: individual participants data not public.
Keywords provided by Biohit Oyj:
smoking
tobacco
smoking cessation