NCT00142779

Brief Summary

Cocaine addiction is a serious health problem with no available medical treatment for preventing relapse. Fluoxetine, a medication that is currently used to treat depression and anxiety disorders, may also be effective at diminishing cocaine use in individuals with severe cocaine addiction. This study will evaluate the effectiveness of fluoxetine at reducing cocaine use in individuals addicted to cocaine and opioids who are concurrently receiving methadone treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2001

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

April 1, 2001

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

September 1, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2005

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

January 12, 2017

Status Verified

May 1, 2009

Enrollment Period

4.8 years

First QC Date

September 1, 2005

Last Update Submit

January 11, 2017

Conditions

Cocaine-Related DisordersOpioid-Related Disorders

Keywords

Cocaine AddictionCocaine DependenceOpiate AddictionOpiate Dependence

Outcome Measures

Primary Outcomes (2)

  • Cocaine use (measured by urine screen and self-report at Week 19 and 33)

  • Medication side effects (measured by self-reports throughout Weeks 8 through 19)

Interventions

FluoxetineDRUG

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Currently dependent on opioids
  • Currently dependent on cocaine
  • Eligible to receive methadone maintenance treatment

You may not qualify if:

  • Current significant medical or psychiatric illness
  • Current use of a specific serotonin reuptake inhibitor (SSRI)
  • History of allergy to SSRI medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Cocaine-Related DisordersOpioid-Related Disorders

Interventions

Fluoxetine

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersNarcotic-Related Disorders

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic Chemicals

Study Officials

  • Eric C. Strain, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

September 1, 2005

First Posted

September 2, 2005

Study Start

April 1, 2001

Primary Completion

January 1, 2006

Study Completion

March 1, 2006

Last Updated

January 12, 2017

Record last verified: 2009-05

Locations

US(1)