Smoking Cessation Assistance With LIBERTAL, A Phospholipid Mixture

Kaplan Medical Center

Status and phase

Completed

Phase 2

Conditions

Smoking

Treatments

Drug: LIBERTAL- a phospholipid mixture

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00317213

LIB-05-2001

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.