NCT00249574

Brief Summary

The purpose of this study is to see whether street-recruited heroin users can be successfully treated for hepatitis C after stabilizing them on buprenorphine.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2003

Typical duration 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

June 1, 2003

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 3, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 7, 2005

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

January 16, 2017

Status Verified

December 1, 2008

Enrollment Period

9 months

First QC Date

November 3, 2005

Last Update Submit

January 13, 2017

Conditions

Hepatitis CHeroin Dependence

Keywords

heroin addiction

Outcome Measures

Primary Outcomes (1)

  • Safety assessments

Secondary Outcomes (2)

  • Effectiveness of medication

  • Compliance

Study Arms (1)

pegInterferon

EXPERIMENTAL

Open label, observational trial to determine the safety of HCV treatment in active IDUs stabilized on buprenorphine/naloxone

Drug: Buprenorphine/naloxoneDrug: pegInterferon

Interventions

Buprenorphine/naloxoneDRUG

Human subjects HIV, HCV

pegInterferon
pegInterferonDRUG

intervention drug 1. buprenorphine/naloxone. street-recruited heroin users induced on bup/naloxone for period of 3-6 months, after which the second intervention is offered. intervention drug 2: pegInterferon/ribavirin. subjects interested in initiation treatment for HCV are offered pegInterferon, 180ug SQ/wk and ribavirin, 800-1200 mg daily for the standard duration of HCV treatment as dictated by genotype.

pegInterferon

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Active heroin or other illicit opioid use
  • Active hepatitis C
  • No medical or psychiatric contraindications
  • Able to sign informed consent

You may not qualify if:

  • No opiate dependence
  • Age \<18
  • Unable or uninterested in attending weekly group sessions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

O.A.S.I.S.

Oakland, California, 94612, United States

Location

MeSH Terms

Conditions

Hepatitis CHeroin Dependence

Interventions

Buprenorphine, Naloxone Drug Combination

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesOpioid-Related DisordersNarcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BuprenorphineMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsNaloxoneHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsDrug CombinationsPharmaceutical Preparations

Study Officials

  • Diana L Sylvestre, M.D.

    Organization to Achieve Solutions in Substance Abuse (OASIS)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Expanded Access
Yes

Study Record Dates

First Submitted

November 3, 2005

First Posted

November 7, 2005

Study Start

June 1, 2003

Primary Completion

March 1, 2004

Study Completion

June 1, 2006

Last Updated

January 16, 2017

Record last verified: 2008-12

Locations

US(1)