Effects of Fatty Acid Supplementation on Substance Dependent Individuals
Primary Purpose
Substance-related Disorders
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Pro-eicosapentaenoic acid (EPA)
Pro-docosapentaenoic acid (DPA)
Placebo
Sponsored by

About this trial
This is an interventional treatment trial for Substance-related Disorders focused on measuring Substance abuse, Depression, Aggression
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Drug Treatment
Placebo treatment
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00312455
First Posted
April 6, 2006
Last Updated
January 11, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT00312455
Brief Title
Effects of Fatty Acid Supplementation on Substance Dependent Individuals
Official Title
Cholesterol and Fatty Acids in Cocaine Addiction Relapse
Study Type
Interventional
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
July 2005 (Actual)
Study Completion Date
July 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance-related Disorders
Keywords
Substance abuse, Depression, Aggression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Drug Treatment
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo treatment
Intervention Type
Drug
Intervention Name(s)
Pro-eicosapentaenoic acid (EPA)
Intervention Description
450 mg 5x/day
Intervention Type
Drug
Intervention Name(s)
Pro-docosapentaenoic acid (DPA)
Intervention Description
100mg 5x/day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
5 capsules/day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laure Buydens-Branchey, MD
Organizational Affiliation
VA New York Harbor Healthcare System
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Effects of Fatty Acid Supplementation on Substance Dependent Individuals
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