The Efficacy of Acetium Lozenges in Intervention for Smoking Cessation

NCT02758743 | Completed

• 1 other identifier: AL-SMOQUIT-2
• Study Type: interventional
• Target: 1,998
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation

Keywords

smoking; tobacco; smoking cessation

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Acetium Lozenge

EXPERIMENTAL

Acetium lozenge (L-cysteine 3mg) is used in context of each cigarette smoked.

Drug: Acetium Lozenge

Placebo

PLACEBO COMPARATOR

Identical in appearance with Acetium lozenge, placebo lozenges will be used in the same manner as in experimental arm.

Drug: Placebo

Interventions

Acetium Lozenge DRUG

Slow-release L-Cysteine to block smoke.derived acetaldehyde in saliva thereby inhibiting the formation of harmans

Acetium Lozenge

Placebo DRUG

Placebo with no active substance will not have the effect on intervention device.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years male/female
• current cigarette smoker
• motivated to quit smoking

You may not qualify if:

• 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

Sponsors & Collaborators

• Biohit Oyj: lead

Study Sites (1)

Kuulas Helsinki

Helsinki, Finland

Location

MeSH Terms

Conditions

Smoking Cessation; Smoking

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Kari Syrjänen, MD, PhD

  Biohit Oyj

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2016
• First Posted: May 2, 2016
• Study Start: April 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: June 23, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)