Effects of Fatty Acid Supplementation on Substance Dependent Individuals

Phase 2

Completed

• Conditions: Substance-related Disorders
• Interventions: Drug: Pro-eicosapentaenoic acid (EPA); Drug: Placebo; Drug: Pro-docosapentaenoic acid (DPA)

• Registration Number: NCT00312455
• Lead Sponsor: National Institute on Drug Abuse (NIDA)

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.

Study Timeline

• Study Start: 2004-07
• Primary Completion: 2005-07
• Study Completion: 2005-07
• Study First Submitted: 2006-04-06
• Study First Submitted QC: 2006-04-06
• Study First Posted: 2006-04-10
• Status Verified: 2008-08
• Last Update Submitted: 2017-01-11
• Last Update Posted: 2017-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Pro-docosapentaenoic acid (DPA)	Drug Treatment
1	Pro-eicosapentaenoic acid (EPA)	Drug Treatment
2	Placebo	Placebo treatment