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Completed

NCT Number: NCT00317213

Smoking Cessation Assistance With LIBERTAL, A Phospholipid Mixture

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.

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Key information

Conditions

Smoking Behavior Health Behavior Smoking Cessation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Arazi Clinic and Modus Clinic

Tel-Aviv and Rehovot, Israel

About this 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LIBERTAL- a phospholipid mixture

Drug

Primary outcomes

  1. Quit Smoking Rates - QSR% as confirmed by CO measurement in exhaled air.

  2. Safety as expressed by adverse-event reporting, clinical, hematological and biochemical parameters.

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Kaplan Medical Center

Other

Collaborators

  • Modus Biological Membranes, Ltd.

Registry information

Official study title

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

Important dates

Study start
2002
Study completion
2002
First posted
Apr 24, 2006
Registry last updated
Apr 14, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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