Smoking Cessation Assistance With LIBERTAL, A Phospholipid Mixture

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.

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.

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.