Smoking Cessation Assistance With LIBERTAL, A Phospholipid Mixture

This study has been completed.
Sponsor:
Collaborator:
Avner Shenfeld PhD, Chief Scientific Officer of Modus Biological Membranes, Ltd.
Information provided by:
Kaplan Medical Center
ClinicalTrials.gov Identifier:
NCT00317213
First received: April 20, 2006
Last updated: April 9, 2008
Last verified: April 2008
  Purpose

It has been shown in rodent models that chronic substance abuse is associated with a rigidification of cell membrane fluidity due to a change in the membrane cholesterol/phospholipids ratio. Upon substance withdrawal the membrane undergoes reequilibration of this ratio, a process resulting both in an acute and a prolonged severe withdrawal syndrome. MBM has developed a patented,phosphatidic acid-enriched phospholipid platform ("LIBERTAL"), which is supposed to facilitate the membrane fluidity recovery. The company has focused on nicotine withdrawal in smoking cessation,as primary target.


Condition Intervention Phase
Smoking
Drug: LIBERTAL- a phospholipid mixture
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Phase IIB Study of the Efficacy and Safety of LIBERTAL, A Phosphatidic-Acid-Enriched Phospholipid, on Smoking Cessation

Resource links provided by NLM:


Further study details as provided by Kaplan Medical Center:

Primary Outcome Measures:
  • Quit Smoking Rates - QSR% as confirmed by CO measurement in exhaled air.
  • Safety as expressed by adverse-event reporting, clinical, hematological and biochemical parameters.

Secondary Outcome Measures:
  • Immunomodulatory potential of Libertal, as expressed by cytokine measurements in frozen cultured PBMC supernatants

Estimated Enrollment: 500
Study Start Date: February 2002
Estimated Study Completion Date: July 2002
Detailed Description:

A randomized,double-blind, dose-finding,phase IIB study with Libertal has been performed in 493 volunteer smokers, wishing to quit. They were divided into 5 arms: 4 treatment groups of 0.5, 1.0, 2.0 and 4.0g/day respectively, and one placebo, divided BID. Treatment was administered during one week prior to smoking cessation, then continued during 8 weeks (56 days), followed by another 4 weeks without treatment (up to day 84). The primary endpoint was complete smoking cessation during at least 28 consecutive days. There were 6 on-site visits and 4 telephone interviews.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Smokers of at least 1 year duration
  • Smoking at least 10 cigarettes/day
  • Having failed at least one previous smoking cessation effort.
  • Without a major cardio-vascular or metabolic disease or condition.

Exclusion Criteria:

  • An uncontrolled major cardiovascular, metabolic, or other condition condition.
  • Need for surgery during the period of participation in the trial.
  • Any treatment for smoking cessation during the 2 months preceding enrollment in the present trial.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00317213

Locations
Israel
Arazi Clinic and Modus Clinic
Tel-Aviv and Rehovot, Israel
Sponsors and Collaborators
Kaplan Medical Center
Avner Shenfeld PhD, Chief Scientific Officer of Modus Biological Membranes, Ltd.
Investigators
Principal Investigator: Zeev T. Handzel, M.D. Kaplan Medical Center
Study Director: Avner Shenfeld, Ph.D, Modus Biological Membranes
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00317213     History of Changes
Other Study ID Numbers: LIB-05-2001
Study First Received: April 20, 2006
Last Updated: April 9, 2008
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Kaplan Medical Center:
Smoking
Nicotine
Withdrawal
Phospholipids
Cell membrane fluidity
Smoking cessation

Additional relevant MeSH terms:
Smoking
Habits

ClinicalTrials.gov processed this record on April 17, 2014