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Effects of Fatty Acid Supplementation on Substance Dependent Individuals

Cholesterol and Fatty Acids in Cocaine Addiction Relapse

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00312455
Enrollment
Unknown
Registered
2006-04-10
Start date
2004-07-31
Completion date
2005-07-31
Last updated
2017-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Substance-related Disorders

Keywords

Substance abuse, Depression, Aggression

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.

Interventions

DRUGPro-eicosapentaenoic acid (EPA)

450 mg 5x/day

DRUGPro-docosapentaenoic acid (DPA)

100mg 5x/day

DRUGPlacebo

5 capsules/day

Sponsors

National Institute on Drug Abuse (NIDA)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
25 Years to 55 Years
Healthy volunteers
No

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026