NCT01131273

Brief Summary

This study will obtain pilot data on the acceptability of a 12-week course of daily observed suboxone and methadone, followed by a dose taper or referral to a local treatment program for 80 opioid dependent patients (40 group) who have been injecting subutex or other buprenorphine preparations 10 or more days in the past 30, and on the impact of each medication on HIV risk and on subutex and opioid use during treatment and a followup at week 20. it will be done at the Uranti Methadone Program, affiliated with the Addiction Research Center, Union Alternative of Georgia in Tbilisi.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at below P25 for phase_3 hiv

Timeline
Completed

Started Jun 2010

Typical duration for phase_3 hiv

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

First Submitted

Initial submission to the registry

April 8, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 26, 2010

Completed
6 days until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

August 19, 2016

Status Verified

August 1, 2016

Enrollment Period

3.2 years

First QC Date

April 8, 2010

Last Update Submit

August 17, 2016

Conditions

HIV

Keywords

buprenorphine injectingopiate dependenceHIV risktreatment outcomeopiate dependence with buprenorphine injecting

Outcome Measures

Primary Outcomes (1)

  • Buprenorphine injecting

    1\) Obtain pilot data on the impact of a 12-week course of daily, observed Suboxone and methadone treatment on HIV injecting risk behavior, particularly that associated with injecting use of Subutex. 2) obtain pilot data on the degree to which the target population accepts treatment with daily observed Suboxone and methadone.

    12 weeks

Secondary Outcomes (1)

  • HIV Risk

    12 weeks

Study Arms (2)

Methadone maintenance for 12 weeks

ACTIVE COMPARATOR

Methadone maintenance for 12 weeks as compared to 12 weeks maintenance on Suboxone.

Drug: methadone

buprenorphine-naloxone (Suboxone)

ACTIVE COMPARATOR

12 weeks of maintenance on buprenorphine-naloxone (Suboxone) at daily doses ranging from 8 to 32 mg with counseling

Drug: buprenorphine-naloxone (Suboxone) for 12 weeks

Interventions

methadoneDRUG

12 weeks of methadone maintenance with counseling

Methadone maintenance for 12 weeks
buprenorphine-naloxone (Suboxone) for 12 weeksDRUG

12 weeks of maintenance with counseling

buprenorphine-naloxone (Suboxone)

Eligibility Criteria

Age25 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • current opioid dependence;
  • injecting buprenorphine 10 or more times in the last 30 days;
  • between 25 and 50 years of age;
  • buprenorphine and/or opiate positive urine test;
  • not on methadone maintenance in last 4 weeks;
  • stable address within Tbilisi and not planning to move;
  • home or cellular phone number where can be reached;
  • able to provide name of family member who knows whereabouts;
  • willingness and ability to give informed consent.

You may not qualify if:

  • currently dependent on alcohol, benzodiazepines or other CNS depressants;
  • legan charges with impending incarceration;
  • plans to move from Tbilisi within next 6 months;
  • current participation in another treatment study;
  • serious medical problems that would impair or make hazardous ability to participate;
  • active TB;
  • currently psychotic/suicidal;
  • uncontrolled seizure disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Union Alternative Georgia

Tbilisi, 0186, Georgia

Location

Related Publications (1)

  • Otiashvili D, Piralishvili G, Sikharulidze Z, Kamkamidze G, Poole S, Woody GE. Methadone and buprenorphine-naloxone are effective in reducing illicit buprenorphine and other opioid use, and reducing HIV risk behavior--outcomes of a randomized trial. Drug Alcohol Depend. 2013 Dec 1;133(2):376-82. doi: 10.1016/j.drugalcdep.2013.06.024. Epub 2013 Jul 31.

    PMID: 23916321DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

MethadoneBuprenorphine, Naloxone Drug CombinationWW Domain-Containing Oxidoreductase

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

KetonesOrganic ChemicalsBuprenorphineMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsNaloxoneHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsDrug CombinationsPharmaceutical PreparationsShort Chain Dehydrogenase-ReductasesNAD (+) and NADP (+) Dependent Alcohol OxidoreductasesAlcohol OxidoreductasesOxidoreductasesEnzymesEnzymes and CoenzymesTumor Suppressor ProteinsNeoplasm ProteinsProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Geroge Woody, MD

    University of Pennsylvania

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2010

First Posted

May 26, 2010

Study Start

June 1, 2010

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

August 19, 2016

Record last verified: 2016-08

Locations

GE(1)