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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
National Institute on Drug Abuse (NIDA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance-related Disorders focused on measuring Substance abuse, Depression, Aggression

Eligibility Criteria

25 Years - 55 Years (Adult)All SexesDoes not accept 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

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

    First Posted
    April 6, 2006
    Last Updated
    January 11, 2017
    Sponsor
    National Institute on Drug Abuse (NIDA)
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    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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