Buprenorphine/Naloxone - Facilitated Rehabilitation for Opioid Dependent Adolescents - 1

NCT ID: NCT00078130

Last Updated: 2017-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

223 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-31

Study Completion Date

2006-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Opioid-Related Disorders

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Buprenorphine/naloxone

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Male and non-pregnant female subjects seeking outpatient treatment for opioid dependence with physiological features without serious medical or psychiatric disorders.
Minimum Eligible Age

14 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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University of Pennsylvania

Principal Investigators

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George Woody, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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Mercy Hospital

Portland, Maine, United States

Site Status

Mountain Manor

Baltimore, Maryland, United States

Site Status

ASAP

Albuquerque, New Mexico, United States

Site Status

Duke Addictions Program

Durham, North Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 36063082 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22215271 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22024000 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20626379 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20393347 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19948382 (View on PubMed)

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.

Reference Type DERIVED
PMID: 18984887 (View on PubMed)

Other Identifiers

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NIDA-CTN-0010-1

Identifier Type: -

Identifier Source: org_study_id

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