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
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, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on September 29, 2014