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| Sponsored by: |
National Institute on Drug Abuse (NIDA) |
|---|---|
| Information provided by: | National Institute on Drug Abuse (NIDA) |
| ClinicalTrials.gov Identifier: | NCT00312455 |
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 II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Parallel Assignment, Efficacy Study |
| 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 |
|---|---|
|
1: Experimental
Drug Treatment
|
Drug: Pro-eicosapentaenoic acid (EPA)
450 mg 5x/day
Drug: Pro-docosapentaenoic acid (DPA)
100mg 5x/day
|
|
2: Placebo Comparator
Placebo treatment
|
Drug: Placebo
5 capsules/day
|
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:
Exclusion Criteria:
Contacts and Locations More Information
| Responsible Party: | VA New York Harbor Healthcare System ( Laure Buydens-Branchey, MD ) |
| Study ID Numbers: | R01DA15360-03, DPMC |
| Study First Received: | April 6, 2006 |
| Last Updated: | August 26, 2008 |
| ClinicalTrials.gov Identifier: | NCT00312455 |
| Health Authority: | United States: Food and Drug Administration |
|
Substance abuse Depression Aggression |
|
Behavior, Addictive Depression Mental Disorders Substance-Related Disorders |
Disorders of Environmental Origin Cocaine Aggression Depressive Disorder |
