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

Prevention of Relapse to Opioid Addiction Using Depot Naltrexone

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.

Study Overview

• Status: Completed
• Conditions: Opiate Addiction
• Intervention / Treatment: Drug: Depot naltrexone; Other: Treatment as Usual (TAU)

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 308
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Treatment Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Treatment as Usual (TAU); Treatment as Usual (TAU) community treatment provided to the participant
Active Comparator: Depot Naltrexone	Drug: Depot naltrexone; Vivitrol® extended release naltrexone 380 mg per month delivered in monthly intramuscular injections.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: 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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: October 24, 2008
• First Submitted That Met QC Criteria: October 28, 2008
• First Posted (Estimate): October 29, 2008

Study Record Updates

• Last Update Posted (Actual): October 23, 2017
• Last Update Submitted That Met QC Criteria: September 21, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Parolees; Opioid addiction prevention; Medication Treatment Alternatives; Prevention of Relapse to Opioid Addiction; Depot naltrexone
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Compulsive Behavior; Impulsive Behavior; Opioid-Related Disorders; Behavior, Addictive; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Narcotic Antagonists; Alcohol Deterrents; Naltrexone
• Other Study ID Numbers: 808422; R01DA024553 (U.S. NIH Grant/Contract)