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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Charles O'Brien, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00781898
First received: October 24, 2008
Last updated: January 9, 2014
Last verified: January 2014

October 24, 2008
January 9, 2014
June 2008
December 2014   (final data collection date for primary outcome measure)
Effect of Depot Naltrexone treatment on Opioid Use [ Time Frame: Monthly during treatment phase (6 months) ] [ Designated as safety issue: No ]
Effect of treatment on Opioid Use [ Time Frame: Monthly during treatment phase (6 months) ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00781898 on ClinicalTrials.gov Archive Site
  • Effect of Depot Naltrexone treatment on HIV risk behavior [ Time Frame: baseline and monthly (for 6 months) during treatment phase ] [ Designated as safety issue: No ]
  • Effect of treatment on arrests and re-incarceration [ Time Frame: Monthly, 6, 12 and 18 month post entry timepoint ] [ Designated as safety issue: No ]
  • Economic costs and benefit costs of naltrexone [ Time Frame: Monthly and 6, 12 and 18 month post entry timepoint ] [ Designated as safety issue: No ]
  • Retention in treatment [ Time Frame: Monthly and 6 month post entry timepoint ] [ Designated as safety issue: No ]
  • Ethical concerns about participants perceived voluntariness for study participation. [ Time Frame: Baseline, month 2, 6, 12 and 18 month Follow-up ] [ Designated as safety issue: No ]
  • Effect of treatment on HIV risk behavior [ Time Frame: baseline and monthly (for 6 months) during treatment phase ] [ Designated as safety issue: No ]
  • Effect of treatment on arrests and re-incarceration [ Time Frame: Monthly, 6, 12 and 18 month post entry timepoint ] [ Designated as safety issue: No ]
  • Economic costs and benefit costs of naltrexone [ Time Frame: Monthly and 6, 12 and 18 month post entry timepoint ] [ Designated as safety issue: No ]
  • Retention in treatment [ Time Frame: Monthly and 6 month post entry timepoint ] [ Designated as safety issue: No ]
  • Ethical concerns about participants perceived voluntariness for study participation. [ Time Frame: Baseline, month 2, 6, 12 and 18 month Follow-up ] [ Designated as safety issue: No ]
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: 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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
400
December 2014
December 2014   (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.

Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00781898
808422, R01DA024553
Yes
Charles O'Brien, 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
January 2014

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