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Depot Naltrexone Treatment of Opioid Dependent Parolees

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00756990
First Posted: September 22, 2008
Last Update Posted: October 2, 2015
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
  Purpose
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: Intervention Model: Single Group Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • Treatment completion [ Time Frame: 6 months ]

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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): NCT00756990


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

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00756990     History of Changes
Other Study ID Numbers: 708310
R01DA024553 ( U.S. NIH Grant/Contract )
First Submitted: September 19, 2008
First Posted: September 22, 2008
Last Update Posted: October 2, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents