Completed

NCT Number: NCT01284660

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

Completed

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Key information

Conditions

HEAVY TOBACCO SMOKERS

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bar Ilan University

Ramat Gan, 52900, Israel

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DHA

Dietary Supplement

DHA ingested orally by heavy smokers

Oral ingestion of 5 placebo tablets

Dietary Supplement

Oral ingestion of 5 tablets containing the following: gelatin,glycerine,water and soy oil made by the Solgar Pharmaceutical Co., Israel

Primary outcomes

Reduction in smoking urges and craving

Time frame: 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

Sponsors and collaborators

Lead sponsor

Hillel Yaffe Medical Center

Other Gov

Registry information

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2013
First posted: Jan 27, 2011
Registry last updated: Dec 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.