Clinical trial NCT00781898: Treatment Study Using Depot Naltrexone (1/6) Philadelphia Coord/Data Mgmt Site
Official title: Prevention of Relapse to Opioid Addiction Using Depot Naltrexone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Opiate Addiction
Keywords: Depot naltrexone
Parolees
Opioid addiction prevention
Medication Treatment Alternatives
Prevention of Relapse to Opioid Addiction
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2008-10-29
Enrollment: 308
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Relapse
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Treatment Research Center
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Charles P O'Brien, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: James W Cornish, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Donna Coviello, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rhode Island Hospital
name: Peter Friedmann, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Mountain Manor Treatment Center, Baltimore MD
name: Timothy Kinlock, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: New York State Psychiatric Institute, New York, NY
name: Edward B. Nunes, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: New York University/Bellevue
name: Josh Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.