Depot Naltrexone Treatment of Opioid Dependent Parolees

This study has been completed.
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
University of Pennsylvania Identifier:
First received: September 19, 2008
Last updated: September 30, 2015
Last verified: September 2015
This is an investigation involving the use of a long-acting, injectable form (depot) of naltrexone as a treatment for persons who have a history of opioid dependence, with up to 40 on parole/probation and 20 non-parolees. The test is a pilot study of up to 60 subjects treated with 6 months of depot naltrexone plus Psychosocial Treatment .

Condition Intervention
Opioid Dependence
Drug: Depot Naltrexone

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Depot Naltrexone Treatment of Opioid Dependent Parolees

Resource links provided by NLM:

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • UDS results [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Treatment completion [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 61
Study Start Date: November 2005
Study Completion Date: August 2011
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single group
Depot Naltrexone
Drug: Depot Naltrexone
228mg of injectable naltrexone
Other Name: Depotrex

Detailed Description:
This is a two phase study. Phase 1 is complete and phase 2 is not yet recruiting.

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion/Exclusion Criteria.

To be eligible to participate, participants must:

  • sign an informed consent form;
  • be between the ages of 18 and 55;
  • have a diagnosis of opioid dependence according to DSM IVTR criteria; and
  • be in good general health as determined by complete physical examination and laboratory tests;
  • have been assigned to a probation/parole period of at least six months; (except those participants not on parole/probation, see note below); and
  • have a negative result for urinary opioids and must self report being at least 3 days opioid free. Participants may have a diagnosis of alcohol dependence so long as they do not have severe alcohol dependence that requires medical supervision for alcohol withdrawal.

Participants with the following characteristics will be excluded from study participation:

  • current severe alcohol dependence that requires medical supervision for alcohol withdrawal;
  • current psychosis, dementia, mental retardation, or history of schizophrenia;
  • significant clinical abnormalities in hematology, chemistry, or urinalysis;
  • significant clinical cardiovascular, neurological, hepatic, renal, pulmonary, metabolic, endocrine, or gastrointestinal disorders;
  • 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);
  • subjects who have taken an opioid antagonist within the prior 6 months; and
  • current diagnosis of chronic pain disorder.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00756990

United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
National Institute on Drug Abuse (NIDA)
Principal Investigator: Charles O'Brien, MD,PhD University of Pennsylvania
  More Information

No publications provided

Responsible Party: University of Pennsylvania Identifier: NCT00756990     History of Changes
Other Study ID Numbers: 708310, R01DA024553
Study First Received: September 19, 2008
Last Updated: September 30, 2015
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Central Nervous System Agents
Narcotic Antagonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses processed this record on November 25, 2015