Effects of Fatty Acid Supplementation on Substance Dependent Individuals

Substance-related Disorders Clinical Trial

Official title:

Cholesterol and Fatty Acids in Cocaine Addiction Relapse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00312455
• Other study ID #: R01DA015360-03
• Secondary ID: DPMC
• Status: Completed
• Phase: Phase 2
• First received: April 6, 2006
• Last updated: January 11, 2017
• Start date: July 2004
• Est. completion date: July 2005

Study information

• Verified date: August 2008
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: July 2005
• Est. primary completion date: July 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Substance-related Disorders

Intervention

Drug:
• Pro-eicosapentaenoic acid (EPA)
450 mg 5x/day
• Pro-docosapentaenoic acid (DPA)
100mg 5x/day
• Placebo
5 capsules/day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)