- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00312455
Effects of Fatty Acid Supplementation on Substance Dependent Individuals
Cholesterol and Fatty Acids in Cocaine Addiction Relapse
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 2
Placebo treatment
|
5 capsules/day
|
Experimental: 1
Drug Treatment
|
450 mg 5x/day
100mg 5x/day
|
Collaborators and Investigators
Investigators
- Principal Investigator: Laure Buydens-Branchey, MD, VA New York Harbor Healthcare System
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01DA015360-03 (U.S. NIH Grant/Contract)
- DPMC (Other Identifier: NIDA)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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