Official Title: “Phase IIB Study of the Efficacy and Safety of LIBERTAL, A Phosphatidic-Acid-Enriched Phospholipid, on Smoking Cessation”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

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.

Intervention(s) in this Clinical Trial

• Drug: LIBERTAL- a phospholipid mixture

Primary 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 Measures

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

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Kaplan Medical Center

Overall Clinical Trial Officials and Contacts

Zeev T. Handzel, M.D. Principal Investigator Kaplan Medical Center  

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00317213

Study ID Number: LIB-05-2001

ClinicalTrials.gov Identifier: NCT00317213

Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration