Smoking Cessation Assistance With LIBERTAL, A Phospholipid Mixture
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Smoking |
Drug: LIBERTAL- a phospholipid mixture |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Phase IIB Study of the Efficacy and Safety of LIBERTAL, A Phosphatidic-Acid-Enriched Phospholipid, on Smoking Cessation |
- Quit Smoking Rates - QSR% as confirmed by CO measurement in exhaled air.
- Safety as expressed by adverse-event reporting, clinical, hematological and biochemical parameters.
- Immunomodulatory potential of Libertal, as expressed by cytokine measurements in frozen cultured PBMC supernatants
| Estimated Enrollment: | 500 |
| Study Start Date: | February 2002 |
| Estimated Study Completion Date: | July 2002 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Israel | |
| Arazi Clinic and Modus Clinic | |
| Tel-Aviv and Rehovot, Israel | |
| Principal Investigator: | Zeev T. Handzel, M.D. | Kaplan Medical Center |
| Study Director: | Avner Shenfeld, Ph.D, | Modus Biological Membranes |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00317213 History of Changes |
| Other Study ID Numbers: | LIB-05-2001 |
| Study First Received: | April 20, 2006 |
| Last Updated: | April 9, 2008 |
| Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
Keywords provided by Kaplan Medical Center:
|
Smoking Nicotine Withdrawal |
Phospholipids Cell membrane fluidity Smoking cessation |
Additional relevant MeSH terms:
|
Smoking Habits |
ClinicalTrials.gov processed this record on May 21, 2013