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

Information source: University of Pennsylvania
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Opiate Addiction

Intervention: Depot naltrexone (Drug); Treatment as Usual (TAU) (Other)

Phase: Phase 2/Phase 3

Status: Active, not recruiting

Sponsored by: University of Pennsylvania

Official(s) and/or principal investigator(s):
Charles P O'Brien, MD, PhD, Principal Investigator, Affiliation: University of Pennsylvania
James W Cornish, MD, Principal Investigator, Affiliation: University of Pennsylvania
Donna Coviello, PhD, Principal Investigator, Affiliation: University of Pennsylvania
Peter Friedmann, MD, MPH, Principal Investigator, Affiliation: Rhode Island Hospital
Timothy Kinlock, PhD, Principal Investigator, Affiliation: Mountain Manor Treatment Center, Baltimore MD
Edward B. Nunes, MD, Principal Investigator, Affiliation: New York State Psychiatric Institute, New York, NY
Josh Lee, MD, Principal Investigator, Affiliation: New York University/Bellevue

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.

Clinical Details

Official title: Prevention of Relapse to Opioid Addiction Using Depot Naltrexone

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Effect of Depot Naltrexone treatment on Opioid Use

Secondary outcome:

Effect of Depot Naltrexone treatment on HIV risk behavior

Effect of treatment on arrests and re-incarceration

Economic costs and benefit costs of naltrexone

Retention in treatment

Ethical concerns about participants perceived voluntariness for study participation.

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

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

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.

Locations and Contacts

Treatment Research Center, Philadelphia, Pennsylvania 19104, United States
Additional Information

Starting date: June 2008
Last updated: January 9, 2014

Page last updated: August 23, 2015

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