Substance-related DisordersPhase 2NCT00312455

Effects of Fatty Acid Supplementation on Substance Dependent Individuals

A Phase 2 study testing Pro-eicosapentaenoic acid (EPA) and Pro-docosapentaenoic acid (DPA) in people with Substance-related Disorders, run by National Institute on Drug Abuse (NIDA).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 25 to 55 years
Conditions the study is for: Substance-related Disorders
What is being tested?: Pro-eicosapentaenoic acid (EPA) and Pro-docosapentaenoic acid (DPA)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: Not given
Where: No sites listed yet
Study dates: Jul 2004to Jul 2005
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 25 to 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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

About this study

Official title: Cholesterol and Fatty Acids in Cocaine Addiction Relapse

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.

Read the 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.

Conditions: Substance-related Disorders
Being tested: Pro-eicosapentaenoic acid (EPA), Pro-docosapentaenoic acid (DPA), Placebo
Keywords: Substance abuse, Depression, Aggression
Medical subject headings: Substance-Related Disorders, Depression, Aggression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT00312455
Study group	Role	What they receive
1	Experimental	Drug Treatment Receives: Drug: Pro-eicosapentaenoic acid (EPA); Drug: Pro-docosapentaenoic acid (DPA)
2	Placebo comparator	Placebo treatment Receives: Drug: Placebo

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2004Jul 2005

First posted10 Apr 2006 (estimated)
Study startJul 2004
Primary completionJul 2005
Study completionJul 2005

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Substance-related DisordersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Care provider

IDs, dates and publications

ClinicalTrials.gov ID: NCT00312455
Sponsor's protocol ID: R01DA015360-03
Other IDs: DPMC
Status last verified: Aug 2008
First submitted: 6 Apr 2006
Last updated: 12 Jan 2017
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Substance-related Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Cholesterol and Fatty Acids in Cocaine Addiction Relapse
ClinicalTrials.gov ID: NCT00312455
Acronym / sponsor ID: R01DA015360-03
Conditions: Substance-related Disorders
Keywords: Substance abuse, Depression, Aggression
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Lead sponsor: National Institute on Drug Abuse (NIDA)US National Institutes of Health
Study start: Jul 2004
Primary completion: Jul 2005 (actual)
Study completion: Jul 2005 (actual)
First posted: 10 Apr 2006 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: Pro-eicosapentaenoic acid (EPA), Drug: Pro-docosapentaenoic acid (DPA)Drug Treatment
2	Placebo comparator	Drug: PlaceboPlacebo treatment

Who may qualify

Ages: 25 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Pro-eicosapentaenoic acid (EPA)450 mg 5x/day	Drug	1
Pro-docosapentaenoic acid (DPA)100mg 5x/day	Drug	1
Placebo5 capsules/day	Drug	2

Primary outcome

Not reported in the source record.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2017.

Related trials for Substance-related Disorders

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Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Recruiting
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Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Laure Buydens-Branchey, MD principal investigator

VA New York Harbor Healthcare System

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pro-eicosapentaenoic acid (EPA) and Pro-docosapentaenoic acid (DPA) in people with Substance-related Disorders, run by National Institute on Drug Abuse (NIDA).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00312455.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2017.