Effects of Fatty Acid Supplementation on Substance Dependent Individuals

Study Overview
=================
Brief Summary
-----------------
Many substance dependent individuals continue to abuse a variety of substances during treatment for their disorder. Often, substance dependent individuals are co-diagnosed with depression and violence problems. Supplements of n-3 polyunsaturated fatty acids (PUFAs) may play a role in treating individuals with such substance abuse problems. The purpose of this study is to evaluate the effectiveness of the n-3 PUFAs eicosapentaenoic acid (EPA) and docosapentaenoic acid (DPA) in treating relapse, aggression, and depression in substance dependent individuals.

Detailed Description
-----------------
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.

Official Title
-----------------
Cholesterol and Fatty Acids in Cocaine Addiction Relapse

Conditions
-----------------
Substance-related Disorders

Intervention / Treatment
-----------------
* Drug: Pro-eicosapentaenoic acid (EPA)
* Drug: Pro-docosapentaenoic acid (DPA)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Current or history of drug or alcohol dependence Used substances of abuse during the 3 months prior to study entry Enrolled in one of the VA New York Harbor Healthcare System Brooklyn campus substance abuse clinics Exclusion Criteria: Current or history of hallucinations, delusions, or memory problems Major physical illness (e.g., cardiovascular, pulmonary, gastrointestinal, renal, neuromuscular, or endocrine disorder) Liver function test greater than one standard deviation above upper normal limit Allergic to fish

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Drug Treatment | Drug: Pro-eicosapentaenoic acid (EPA)<br>* 450 mg 5x/day<br>Drug: Pro-docosapentaenoic acid (DPA)<br>* 100mg 5x/day<br>|
| Placebo Comparator: 2<br>Placebo treatment | Drug: Placebo<br>* 5 capsules/day<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Substance abuse, Depression, Aggression