Effects of Fatty Acid Supplementation on Substance Dependent Individuals
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|ClinicalTrials.gov Identifier: NCT00312455|
Recruitment Status : Completed
First Posted : April 10, 2006
Last Update Posted : January 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Substance-related Disorders||Drug: Pro-eicosapentaenoic acid (EPA) Drug: Pro-docosapentaenoic acid (DPA) Drug: Placebo||Phase 2|
Past research suggests that low levels of some PUFAs play a role in the pathophysiology of depressive and aggressive disorders. In addition, there is also evidence that PUFAs play a role in treating substance dependent individuals. The purpose of this study is to determine the efficacy of EFA and DPA in treating substance dependent individuals.
Participants will be randomly assigned to receive either 3 grams of n-3 PUFAs or placebo. Treatment will last 3 months, followed by an observation period of 3 months. Study visits will occur monthly and will last approximately one hour. Study visits will include blood tests and a physical exam. Throughout the study, participants will continue to receive standard substance abuse treatment and will complete urine tests at regular intervals.
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Cholesterol and Fatty Acids in Cocaine Addiction Relapse|
|Study Start Date :||July 2004|
|Actual Primary Completion Date :||July 2005|
|Actual Study Completion Date :||July 2005|
Drug: Pro-eicosapentaenoic acid (EPA)
450 mg 5x/dayDrug: Pro-docosapentaenoic acid (DPA)
Placebo Comparator: 2
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): NCT00312455
|Principal Investigator:||Laure Buydens-Branchey, MD||VA New York Harbor Healthcare System|