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

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ClinicalTrials.gov Identifier: NCT00781898
Recruitment Status : Completed
First Posted : October 29, 2008
Results First Posted : October 23, 2017
Last Update Posted : October 23, 2017
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
Opiate Addiction Drug: Depot naltrexone Other: Treatment as Usual (TAU) Phase 2 Phase 3

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 308 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prevention of Relapse to Opioid Addiction Using Depot Naltrexone
Study Start Date : June 2008
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Depot Naltrexone Drug: Depot naltrexone
Vivitrol® extended release naltrexone 380 mg per month delivered in monthly intramuscular injections.
Placebo Comparator: Placebo Other: Treatment as Usual (TAU)
Treatment as Usual (TAU) community treatment provided to the participant



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00781898


Locations
United States, Pennsylvania
Treatment Research Center
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
National Institute on Drug Abuse (NIDA)
Investigators
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00781898     History of Changes
Other Study ID Numbers: 808422
R01DA024553 ( U.S. NIH Grant/Contract )
First Posted: October 29, 2008    Key Record Dates
Results First Posted: October 23, 2017
Last Update Posted: October 23, 2017
Last Verified: September 2017

Keywords provided by University of Pennsylvania:
Depot naltrexone
Parolees
Opioid addiction prevention
Medication Treatment Alternatives
Prevention of Relapse to Opioid Addiction

Additional relevant MeSH terms:
Impulsive Behavior
Behavior, Addictive
Opioid-Related Disorders
Compulsive Behavior
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Naltrexone
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists