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

HEAVY TOBACCO SMOKERS Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01284660
• Other study ID #: 00009-11 HYMC
• Status: Completed
• Phase: N/A
• First received: January 18, 2011
• Last updated: December 18, 2013
• Start date: November 2011
• Est. completion date: September 2013

Study information

• Verified date: December 2013
• Source: Hillel Yaffe Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: September 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• HEAVY TOBACCO SMOKERS

Intervention

Dietary Supplement:
• DHA
DHA ingested orally by heavy smokers
• 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

Locations

Country	Name	City	State
Israel	Bar Ilan University	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No