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
  Purpose

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 Intervention Phase
Opiate Addiction
Drug: Depot naltrexone
Other: Treatment as Usual (TAU)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prevention of Relapse to Opioid Addiction Using Depot Naltrexone

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Effect of Depot Naltrexone treatment on Opioid Use [ Time Frame: Monthly during treatment phase (6 months) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 400
Study Start Date: June 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00781898

Locations
United States, Pennsylvania
Treatment Research Center
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
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
  More Information

No publications provided

Responsible Party: Charles O'Brien, Principal Investigator, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00781898     History of Changes
Other Study ID Numbers: 808422, R01DA024553
Study First Received: October 24, 2008
Last Updated: January 9, 2014
Health Authority: United States: Food and Drug Administration

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:
Behavior, Addictive
Opioid-Related Disorders
Compulsive Behavior
Impulsive Behavior
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Naltrexone
Analgesics, Opioid
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Narcotics
Central Nervous System Depressants
Analgesics

ClinicalTrials.gov processed this record on August 26, 2014