Smoking Cessation Assistance With LIBERTAL, A Phospholipid Mixture

Smoking Clinical Trial

Official title:

Phase IIB Study of the Efficacy and Safety of LIBERTAL, A Phosphatidic-Acid-Enriched Phospholipid, on Smoking Cessation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00317213
• Other study ID #: LIB-05-2001
• Status: Completed
• Phase: Phase 2
• First received: April 20, 2006
• Last updated: April 9, 2008
• Start date: February 2002
• Est. completion date: July 2002

Study information

• Verified date: April 2008
• Source: Kaplan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: July 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking

Intervention

Drug:
• LIBERTAL- a phospholipid mixture

Locations

Country	Name	City	State
Israel	Arazi Clinic and Modus Clinic	Tel-Aviv and Rehovot

Sponsors (2)

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

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quit Smoking Rates - QSR% as confirmed by CO measurement in exhaled air.
Primary	Safety as expressed by adverse-event reporting, clinical, hematological and biochemical parameters.
Secondary	Immunomodulatory potential of Libertal, as expressed by cytokine measurements in frozen cultured PBMC supernatants