Effects of Fatty Acid Supplementation on Substance Dependent Individuals

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.

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Key information

Conditions

Substance-related Disorders Aberrant Motor Behavior in Dementia Aggression Behavior Behavioral Symptoms Chemically-Induced Disorders Depression Mental Disorders Social Behavior

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pro-eicosapentaenoic acid (EPA)

Drug

450 mg 5x/day

Pro-docosapentaenoic acid (DPA)

Drug

100mg 5x/day

Placebo

Drug

5 capsules/day

Sponsors and collaborators

Lead sponsor

National Institute on Drug Abuse (NIDA)

Nih

Registry information

Official study title

Cholesterol and Fatty Acids in Cocaine Addiction Relapse

Important dates

Study start: 2004
Primary completion: 2005
Study completion: 2005
First posted: Apr 10, 2006
Registry last updated: Jan 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed