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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Hillel Yaffe Medical Center

ClinicalTrials.gov Identifier:

NCT01284660

First received: January 18, 2011

Last updated: December 18, 2013

Last verified: December 2013

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

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


Enrollment:	51
Study Start Date:	November 2011
Study Completion Date:	September 2013
Primary Completion Date:	July 2013 (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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01284660

Locations


Israel
Bar Ilan University
Ramat Gan, Israel, 52900

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:	December 18, 2013
Health Authority:	Israel: Ministry of Health

ClinicalTrials.gov processed this record on February 27, 2015

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