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Treatment Study Using Depot Naltrexone (1/6) Philadelphia Coord/Data Mgmt Site

NCT ID: NCT00781898

Last Updated: 2017-10-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

308 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2015-08-31

Brief Summary

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The aim of this project is to conduct a multi-site effectiveness study to determine whether the addition of a monthly injection of depot naltrexone to treatment as usual (TAU) will significantly improve outcome in parolees and probationers with a history of opioid addiction compared to TAU alone. Participants will be randomized to either treatment as usual in community programs or monthly injections of depot naltrexone for six months with treatment as usual in community programs. The effectiveness of depot naltrexone has never been studied in opioid dependent parolees. all parolee subjects will be evaluated at baseline, while in treatment, and at 6, 12 and 18 month post entry time points. The primary study outcomes are retention in treatment, drug use, re-arrests, psychosocial and medical/psychiatric functioning, and economic costs and benefit costs of naltrexone.

Detailed Description

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This site serves as the coordinating center for five sites conducting the trial under the same IND and same protocol.

Conditions

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Opiate Addiction

Keywords

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Depot naltrexone Parolees Opioid addiction prevention Medication Treatment Alternatives Prevention of Relapse to Opioid Addiction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Depot Naltrexone

Group Type ACTIVE_COMPARATOR

Depot naltrexone

Intervention Type DRUG

Vivitrol® extended release naltrexone 380 mg per month delivered in monthly intramuscular injections.

Placebo

Group Type PLACEBO_COMPARATOR

Treatment as Usual (TAU)

Intervention Type OTHER

Treatment as Usual (TAU) community treatment provided to the participant

Interventions

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Depot naltrexone

Vivitrol® extended release naltrexone 380 mg per month delivered in monthly intramuscular injections.

Intervention Type DRUG

Treatment as Usual (TAU)

Treatment as Usual (TAU) community treatment provided to the participant

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Be between the ages of 18 and 60;
* Have dx of opioid dependence according to DSM-IV criteria
* be in good general health as determined by complete physical and laboratory tests;
* Under some form of criminal justice supervision for at least 12 months;
* Have a negative result for urinary opioids and no sign of opiate withdrawal after IV (or IM) injection of 0.8 mg of naloxone; and
* Express a goal of opiate free treatment rather than agonist maintenance

Exclusion Criteria

* Current drug or alcohol dependence that requires medical supervision;
* untreated psychiatric disorders that might make participation hazardous (e.g. untreated psychosis, bipolar disorder with mania, significant suicide risk). Adequately treated psychiatric disorders and appropriate psychotropic medications would be allowed.

3\. Active medical illness that might make participation hazardous (e.g., untreated hypertension, hepatitis with AST or ALT \>3 times upper limit of normal, unstable diabetes or heart disease). Adequately treated medical conditions are acceptable; 4. female subjects who are pregnant or lactating, or female subjects of childbearing potential who are not using birth control (oral contraceptives, barrier (diaphragm or condom) plus spermicide, or levonorgestriel implant); 5. Liver failure or liver function test levels greater than three times normal; 6. History of allergic reaction to naltrexone; 7. History of a drug overdose in the past 3 years; and 8. Current diagnosis of chronic pain disorder for which opioids are prescribed for pain relief.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Charles P O'Brien, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

James W Cornish, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Donna Coviello, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Peter Friedmann, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Rhode Island Hospital

Timothy Kinlock, PhD

Role: PRINCIPAL_INVESTIGATOR

Mountain Manor Treatment Center, Baltimore MD

Edward B. Nunes, MD

Role: PRINCIPAL_INVESTIGATOR

New York State Psychiatric Institute, New York, NY

Josh Lee, MD

Role: PRINCIPAL_INVESTIGATOR

New York University/Bellevue

Locations

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Treatment Research Center

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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Kornor H, Lobmaier PPK, Kunoe N. Sustained-release naltrexone for opioid dependence. Cochrane Database Syst Rev. 2025 May 9;5(5):CD006140. doi: 10.1002/14651858.CD006140.pub3.

Reference Type DERIVED
PMID: 40342086 (View on PubMed)

Chen DT, Ko TM, Allen AA, Bonnie RJ, Suratt CE, Appelbaum PS, Nunes EV, Friedmann PD, Lee JD, Gordon MS, McDonald R, Wilson D, Boney TY, Murphy SM, O'Brien CP. Personal Control Over Decisions to Participate in Research by Persons With Histories of Both Substance Use Disorders and Criminal Justice Supervision. J Empir Res Hum Res Ethics. 2018 Apr;13(2):160-172. doi: 10.1177/1556264618755243. Epub 2018 Feb 20.

Reference Type DERIVED
PMID: 29460668 (View on PubMed)

Lee JD, Friedmann PD, Kinlock TW, Nunes EV, Boney TY, Hoskinson RA Jr, Wilson D, McDonald R, Rotrosen J, Gourevitch MN, Gordon M, Fishman M, Chen DT, Bonnie RJ, Cornish JW, Murphy SM, O'Brien CP. Extended-Release Naltrexone to Prevent Opioid Relapse in Criminal Justice Offenders. N Engl J Med. 2016 Mar 31;374(13):1232-42. doi: 10.1056/NEJMoa1505409.

Reference Type DERIVED
PMID: 27028913 (View on PubMed)

Lee JD, Friedmann PD, Boney TY, Hoskinson RA Jr, McDonald R, Gordon M, Fishman M, Chen DT, Bonnie RJ, Kinlock TW, Nunes EV, Cornish JW, O'Brien CP. Extended-release naltrexone to prevent relapse among opioid dependent, criminal justice system involved adults: rationale and design of a randomized controlled effectiveness trial. Contemp Clin Trials. 2015 Mar;41:110-7. doi: 10.1016/j.cct.2015.01.005. Epub 2015 Jan 17.

Reference Type DERIVED
PMID: 25602580 (View on PubMed)

Other Identifiers

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R01DA024553

Identifier Type: NIH

Identifier Source: secondary_id

View Link

808422

Identifier Type: -

Identifier Source: org_study_id