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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00781898
First Posted: October 29, 2008
Last Update Posted: October 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Pennsylvania
October 24, 2008
October 29, 2008
April 17, 2017
October 23, 2017
October 23, 2017
June 2008
August 2015   (Final data collection date for primary outcome measure)
Relapse [ Time Frame: 6 months ]
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.
Effect of treatment on Opioid Use [ Time Frame: Monthly during treatment phase (6 months) ]
Complete list of historical versions of study NCT00781898 on ClinicalTrials.gov Archive Site
Not Provided
  • Effect of treatment on HIV risk behavior [ Time Frame: baseline and monthly (for 6 months) during treatment phase ]
  • Effect of treatment on arrests and re-incarceration [ Time Frame: Monthly, 6, 12 and 18 month post entry timepoint ]
  • Economic costs and benefit costs of naltrexone [ Time Frame: Monthly and 6, 12 and 18 month post entry timepoint ]
  • Retention in treatment [ Time Frame: Monthly and 6 month post entry timepoint ]
  • Ethical concerns about participants perceived voluntariness for study participation. [ Time Frame: Baseline, month 2, 6, 12 and 18 month Follow-up ]
Not Provided
Not Provided
 
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.
This site serves as the coordinating center for five sites conducting the trial under the same IND and same protocol.
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Opiate Addiction
  • Drug: Depot naltrexone
    Vivitrol® extended release naltrexone 380 mg per month delivered in monthly intramuscular injections.
  • Other: Treatment as Usual (TAU)
    Treatment as Usual (TAU) community treatment provided to the participant
  • Active Comparator: Depot Naltrexone
    Intervention: Drug: Depot naltrexone
  • Placebo Comparator: Placebo
    Intervention: Other: Treatment as Usual (TAU)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
308
August 2015
August 2015   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00781898
808422
R01DA024553 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
University of Pennsylvania
University of Pennsylvania
National Institute on Drug Abuse (NIDA)
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
University of Pennsylvania
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP