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

Hillel Yaffe Medical Center

Status: Completed

Conditions: HEAVY TOBACCO SMOKERS

Treatments: Dietary Supplement: DHA; Dietary Supplement: Oral ingestion of 5 placebo tablets

Study type: Interventional

Funder types: Other

Identifiers

NCT01284660

00009-11 HYMC

Details and patient eligibility

About

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

Enrollment: 51 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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51 participants in 2 patient groups, including a placebo group

I. DHA

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: DHA

II. Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Oral ingestion of 5 placebo tablets