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Effects of Fatty Acid Supplementation on Substance Dependent Individuals

National Institutes of Health (NIH) logo

National Institutes of Health (NIH)

Status and phase

Completed
Phase 2

Conditions

Substance-related Disorders

Treatments

Drug: Pro-docosapentaenoic acid (DPA)
Drug: Placebo
Drug: Pro-eicosapentaenoic acid (EPA)

Study type

Interventional

Funder types

NIH

Identifiers

NCT00312455
DPMC
R01DA015360-03

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

25 to 55 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

0 participants in 2 patient groups, including a placebo group

1
Experimental group
Description:
Drug Treatment
Treatment:
Drug: Pro-eicosapentaenoic acid (EPA)
Drug: Pro-docosapentaenoic acid (DPA)
2
Placebo Comparator group
Description:
Placebo treatment
Treatment:
Drug: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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