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 behaviorEffect 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
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