Effects of Fatty Acid Supplementation on Substance Dependent Individuals
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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 |
| 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 |
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 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 May 21, 2013