NCT00312455

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jul 2004

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 10, 2006

Completed
Last Updated

January 12, 2017

Status Verified

August 1, 2008

Enrollment Period

1 year

First QC Date

April 6, 2006

Last Update Submit

January 11, 2017

Conditions

Substance-related Disorders

Keywords

Substance abuseDepressionAggression

Study Arms (2)

1

EXPERIMENTAL

Drug Treatment

Drug: Pro-eicosapentaenoic acid (EPA)Drug: Pro-docosapentaenoic acid (DPA)

2

PLACEBO COMPARATOR

Placebo treatment

Drug: Placebo

Interventions

Pro-eicosapentaenoic acid (EPA)DRUG

450 mg 5x/day

1
Pro-docosapentaenoic acid (DPA)DRUG

100mg 5x/day

1
PlaceboDRUG

5 capsules/day

2

Eligibility Criteria

Age25 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Substance-Related DisordersDepressionAggression

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersBehavioral SymptomsBehaviorAberrant Motor Behavior in DementiaSocial Behavior

Study Officials

  • Laure Buydens-Branchey, MD

    VA New York Harbor Healthcare System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

April 6, 2006

First Posted

April 10, 2006

Study Start

July 1, 2004

Primary Completion

July 1, 2005

Study Completion

July 1, 2005

Last Updated

January 12, 2017

Record last verified: 2008-08