NCT00781898

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
308

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2008

Longer than P75 for phase_2

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, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 29, 2008

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

October 23, 2017

Completed
Last Updated

October 23, 2017

Status Verified

September 1, 2017

Enrollment Period

7.2 years

First QC Date

October 24, 2008

Results QC Date

April 17, 2017

Last Update Submit

September 21, 2017

Conditions

Opiate Addiction

Keywords

Depot naltrexoneParoleesOpioid addiction preventionMedication Treatment AlternativesPrevention of Relapse to Opioid Addiction

Outcome Measures

Primary Outcomes (1)

  • Relapse

    A relapse event was defined as 10 or more days of opioid use in a 28-day (4-week) period as assessed by self-report or by testing of urine samples obtained every 2 weeks; a positive or missing sample was computed as 5 days of opioid use.

    6 months

Study Arms (2)

Depot Naltrexone

ACTIVE COMPARATOR
Drug: Depot naltrexone

Placebo

PLACEBO COMPARATOR
Other: Treatment as Usual (TAU)

Interventions

Depot naltrexoneDRUG

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

Depot Naltrexone
Treatment as Usual (TAU)OTHER

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

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Treatment Research Center

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (4)

  • 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.

    PMID: 40342086DERIVED

  • 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.

    PMID: 29460668DERIVED

  • 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.

    PMID: 27028913DERIVED

  • 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.

    PMID: 25602580DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Results Point of Contact

Title
Charle P. O'Brien
Organization
University Of Pennsylvania
obrien@mail.med.upenn.edu
215-222-3200

Study Officials

  • Charles P O'Brien, MD, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

  • James W Cornish, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

  • Donna Coviello, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

  • Peter Friedmann, MD, MPH

    Rhode Island Hospital

    PRINCIPAL INVESTIGATOR

  • Timothy Kinlock, PhD

    Mountain Manor Treatment Center, Baltimore MD

    PRINCIPAL INVESTIGATOR

  • Edward B. Nunes, MD

    New York State Psychiatric Institute, New York, NY

    PRINCIPAL INVESTIGATOR

  • Josh Lee, MD

    New York University/Bellevue

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2008

First Posted

October 29, 2008

Study Start

June 1, 2008

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

October 23, 2017

Results First Posted

October 23, 2017

Record last verified: 2017-09

Locations

US(1)