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

NCT01284660 | Completed DMC

• 1 other identifier: 00009-11 HYMC
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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

Conditions

HEAVY TOBACCO SMOKERS

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

I. DHA

ACTIVE COMPARATOR

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

II. Placebo

PLACEBO COMPARATOR

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

Interventions

DHA DIETARY_SUPPLEMENT

DHA ingested orally by heavy smokers

I. DHA

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

II. Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Nicotine dependence
• Smoked at least 10 cigarettes per day for the past 12 months and not interested in quitting

You may not qualify if:

• Serious kidney, lun, neurological and cardiovascular diseases
• Suicide risk, acute psychosis, severe depression, organic brain syndromes
• Dependence on psychoactive substances other than nicotine

Sponsors & Collaborators

• Hillel Yaffe Medical Center: lead

Study Sites (1)

Bar Ilan University

Ramat Gan, 52900, Israel

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2011
• First Posted: January 27, 2011
• Study Start: November 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: September 1, 2013
• Last Updated: December 19, 2013

Record last verified: 2013-12

Locations

IL (1)