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

Not Applicable

Completed

• Conditions: HEAVY TOBACCO SMOKERS
• Interventions: Dietary Supplement: DHA; Dietary Supplement: Oral ingestion of 5 placebo tablets

• Registration Number: NCT01284660
• Lead Sponsor: Hillel Yaffe Medical Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-01-18
• Study First Submitted QC: 2011-01-26
• Study First Posted: 2011-01-27
• Study Start: 2011-11
• Primary Completion: 2013-07
• Study Completion: 2013-09
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-18
• Last Update Posted: 2013-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
I. DHA	DHA	Oral ingestion 5 tablets DHA + EPA (daily ingestion DHA 2040 mg and EPA 2710 mg)- (Omega 3 - 950,the Solgar Pharmaceutical Co., Israel).
II. Placebo	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

Primary Outcome Measures

Name	Time	Method
Reduction in smoking urges and craving	One and a half years	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

Trial Locations

Locations (1)

Bar Ilan University; 🇮🇱 Ramat Gan, Israel