Effects of Fatty Acid Supplementation on Substance Dependent Individuals

This study has been completed.
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00312455
First received: April 6, 2006
Last updated: August 26, 2008
Last verified: August 2008
  Purpose

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.


Condition Intervention Phase
Substance-Related Disorders
Drug: Pro-eicosapentaenoic acid (EPA)
Drug: Pro-docosapentaenoic acid (DPA)
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Cholesterol and Fatty Acids in Cocaine Addiction Relapse

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Study Start Date: July 2004
Study Completion Date: July 2005
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Drug Treatment
Drug: Pro-eicosapentaenoic acid (EPA)
450 mg 5x/day
Drug: Pro-docosapentaenoic acid (DPA)
100mg 5x/day
Placebo Comparator: 2
Placebo treatment
Drug: Placebo
5 capsules/day

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.

  Eligibility

Ages Eligible for Study:   25 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00312455

Sponsors and Collaborators
Investigators
Principal Investigator: Laure Buydens-Branchey, MD VA New York Harbor Healthcare System
  More Information

No publications provided

Responsible Party: Laure Buydens-Branchey, MD, VA New York Harbor Healthcare System
ClinicalTrials.gov Identifier: NCT00312455     History of Changes
Other Study ID Numbers: R01DA15360-03, DPMC
Study First Received: April 6, 2006
Last Updated: August 26, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute on Drug Abuse (NIDA):
Substance abuse
Depression
Aggression

Additional relevant MeSH terms:
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 23, 2014