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

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

Study Overview

• Status: Completed
• Conditions: HEAVY TOBACCO SMOKERS
• Intervention / Treatment: Dietary supplement: DHA; Dietary supplement: Oral ingestion of 5 placebo tablets

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Ramat Gan, Israel, 52900
    • Bar Ilan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in smoking urges and craving	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	One and a half years

Collaborators and Investigators

• Sponsor: Hillel Yaffe Medical Center

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): July 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: January 18, 2011
• First Submitted That Met QC Criteria: January 26, 2011
• First Posted (Estimate): January 27, 2011

Study Record Updates

• Last Update Posted (Estimate): December 19, 2013
• Last Update Submitted That Met QC Criteria: December 18, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: 00009-11 HYMC