NCT00078130

Brief Summary

The purpose of this study is to compare two 3-month treatments for adolescents/young adults who are addicted to heroin: buprenorphine/naloxone combined with psychosocial therapy and treatment as usual, a 7-14 day detoxification with buprenorphine and three weeks of psychosocial therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
223

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2003

Typical duration for phase_3

Geographic Reach
1 country

4 active sites

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, 2003

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 20, 2004

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
Last Updated

January 12, 2017

Status Verified

October 1, 2016

Enrollment Period

2.5 years

First QC Date

February 19, 2004

Last Update Submit

January 11, 2017

Conditions

Opioid-Related Disorders

Keywords

opioid dependencebehavioral intervention

Outcome Measures

Primary Outcomes (1)

  • Opiate abstinence

Interventions

Buprenorphine/naloxoneDRUG

Eligibility Criteria

Age14 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Male and non-pregnant female subjects seeking outpatient treatment for opioid dependence with physiological features without serious medical or psychiatric disorders.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (4)

Mercy Hospital

Portland, Maine, 04092, United States

Location

Mountain Manor

Baltimore, Maryland, 21229, United States

Location

ASAP

Albuquerque, New Mexico, 87106, United States

Location

Duke Addictions Program

Durham, North Carolina, 27710, United States

Location

Related Publications (7)

  • Nielsen S, Tse WC, Larance B. Opioid agonist treatment for people who are dependent on pharmaceutical opioids. Cochrane Database Syst Rev. 2022 Sep 5;9(9):CD011117. doi: 10.1002/14651858.CD011117.pub3.

    PMID: 36063082DERIVED

  • Schackman BR, Leff JA, Polsky D, Moore BA, Fiellin DA. Cost-effectiveness of long-term outpatient buprenorphine-naloxone treatment for opioid dependence in primary care. J Gen Intern Med. 2012 Jun;27(6):669-76. doi: 10.1007/s11606-011-1962-8. Epub 2012 Jan 4.

    PMID: 22215271DERIVED

  • Subramaniam GA, Warden D, Minhajuddin A, Fishman MJ, Stitzer ML, Adinoff B, Trivedi M, Weiss R, Potter J, Poole SA, Woody GE. Predictors of abstinence: National Institute of Drug Abuse multisite buprenorphine/naloxone treatment trial in opioid-dependent youth. J Am Acad Child Adolesc Psychiatry. 2011 Nov;50(11):1120-8. doi: 10.1016/j.jaac.2011.07.010.

    PMID: 22024000DERIVED

  • Polsky D, Glick HA, Yang J, Subramaniam GA, Poole SA, Woody GE. Cost-effectiveness of extended buprenorphine-naloxone treatment for opioid-dependent youth: data from a randomized trial. Addiction. 2010 Sep;105(9):1616-24. doi: 10.1111/j.1360-0443.2010.03001.x. Epub 2010 Jul 12.

    PMID: 20626379DERIVED

  • Meade CS, Weiss RD, Fitzmaurice GM, Poole SA, Subramaniam GA, Patkar AA, Connery HS, Woody GE. HIV risk behavior in treatment-seeking opioid-dependent youth: results from a NIDA clinical trials network multisite study. J Acquir Immune Defic Syndr. 2010 Sep;55(1):65-72. doi: 10.1097/QAI.0b013e3181d916db.

    PMID: 20393347DERIVED

  • Chakrabarti A, Woody GE, Griffin ML, Subramaniam G, Weiss RD. Predictors of buprenorphine-naloxone dosing in a 12-week treatment trial for opioid-dependent youth: secondary analyses from a NIDA Clinical Trials Network study. Drug Alcohol Depend. 2010 Mar 1;107(2-3):253-6. doi: 10.1016/j.drugalcdep.2009.10.014. Epub 2009 Nov 30.

    PMID: 19948382DERIVED

  • Woody GE, Poole SA, Subramaniam G, Dugosh K, Bogenschutz M, Abbott P, Patkar A, Publicker M, McCain K, Potter JS, Forman R, Vetter V, McNicholas L, Blaine J, Lynch KG, Fudala P. Extended vs short-term buprenorphine-naloxone for treatment of opioid-addicted youth: a randomized trial. JAMA. 2008 Nov 5;300(17):2003-11. doi: 10.1001/jama.2008.574.

    PMID: 18984887DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Buprenorphine, Naloxone Drug Combination

Condition Hierarchy (Ancestors)

Narcotic-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

  • George Woody, M.D.

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 19, 2004

First Posted

February 20, 2004

Study Start

July 1, 2003

Primary Completion

January 1, 2006

Study Completion

January 1, 2006

Last Updated

January 12, 2017

Record last verified: 2016-10

Locations

US(4)