Smoking Cessation Assistance With LIBERTAL, A Phospholipid Mixture

• Status: Completed
• Trial end date: 2002-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kaplan Medical Center
• Collaborator: Modus Biological Membranes, Ltd.

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.