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

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ClinicalTrials.gov Identifier: NCT01284660
Recruitment Status : Completed
First Posted : January 27, 2011
Last Update Posted : December 19, 2013
Sponsor:
Information provided by (Responsible Party):
Hillel Yaffe Medical Center

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Condition or disease Intervention/treatment Phase
HEAVY TOBACCO SMOKERS Dietary Supplement: DHA Dietary Supplement: Oral ingestion of 5 placebo tablets Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Study Start Date : November 2011
Actual Primary Completion Date : July 2013
Actual Study Completion Date : September 2013
Arms and Interventions
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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


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01284660


Locations
Israel
Bar Ilan University
Ramat Gan, Israel, 52900
Sponsors and Collaborators
Hillel Yaffe Medical Center
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT01284660     History of Changes
Other Study ID Numbers: 00009-11 HYMC
First Posted: January 27, 2011    Key Record Dates
Last Update Posted: December 19, 2013
Last Verified: December 2013