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Docosahexaenoic Acid (DHA) Effects on Cognitive Function, Craving and Psychosocial Factors in Heavy Cigarette Smokers

This study is currently recruiting participants.
Verified November 2011 by Hillel Yaffe Medical Center
Sponsor:
Information provided by (Responsible Party):
Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:
NCT01284660
First received: January 18, 2011
Last updated: November 2, 2011
Last verified: November 2011
History of Changes
  Purpose

The purpose of this study is to assess effects of Docosahexaenoic Acid (DHA) as an add-on novel supplement on quality of life, cognitive function, craving and psychosocial factors in heavy cigarette smokers. In humans, no previous randomized, double blind controlled study has been conducted to evaluate these effects. The aim of the study is to 1. Test Docosahexaenoic Acid (DHA) beneficial effects on objective clinical indicators of cognitive function (choice reaction time, decision making, impulsivity, facial recognition) in smokers 2. Improvement of quality of life, cigarette craving, psychosocial factors and self-perceptions in smokers treated with DHA supplement


Condition Intervention
HEAVY TOBACCO SMOKERS
 Dietary Supplement: DHA
Dietary Supplement: Oral ingestion of 5 placebo tablets

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hillel Yaffe Medical Center:

Primary Outcome Measures:
  • Reduction in smoking urges and craving [ Time Frame: One and a half years ] [ Designated as safety issue: No ]
    Reduction in smoking urges and craving to be measured by the following: smoking urges and craving scales; choice reaction time, impulsivity computerized test, quality of life questionnaire, depression inventory, general health questionnaire, scale of perceived social support, facial expression task, self-esteem diary


Estimated Enrollment: 80
Study Start Date: November 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: I. DHA
Oral ingestion 5 tablets DHA + EPA (daily ingestion DHA 2040 mg and EPA 2710 mg)- (Omega 3 - 950,the Solgar Pharmaceutical Co., Israel).
 Dietary Supplement: DHA
DHA ingested orally by heavy smokers
Placebo Comparator: II. Placebo
Oral ingestion of 5 tablets containing the following: gelatin,glycerine,water and soy oil made by the Solgar Pharmaceutical Co., Israel
 Dietary Supplement: Oral ingestion of 5 placebo tablets
Oral ingestion of 5 tablets containing the following: gelatin,glycerine,water and soy oil made by the Solgar Pharmaceutical Co., Israel

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Nicotine dependence
  • Smoked at least 10 cigarettes per day for the past 12 months and not interested in quitting

Exclusion Criteria:

  • Serious kidney, lun, neurological and cardiovascular diseases
  • Suicide risk, acute psychosis, severe depression, organic brain syndromes
  • Dependence on psychoactive substances other than nicotine
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01284660

Contacts
Contact: Sharon Rabinovitz, PhD 972-3-5318221 sharonrs123@gmail.com

Locations
Israel
Bar Ilan University Recruiting
Ramat Gan, Israel, 52900
Principal Investigator: Sharon Rabinovitz, PhD            
Sub-Investigator: Rafael Carasso, MD, PhD            
Sub-Investigator: Shlomo Yehuda, PhD            
Sponsors and Collaborators
Hillel Yaffe Medical Center
  More Information

No publications provided

Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT01284660     History of Changes
Other Study ID Numbers: 00009-11 HYMC
Study First Received: January 18, 2011
Last Updated: November 2, 2011
Health Authority: Israel: Ministry of Health

ClinicalTrials.gov processed this record on May 16, 2013