Depot Naltrexone Treatment of Opioid Dependent Parolees

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by National Institute on Drug Abuse (NIDA).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00756990
First received: September 19, 2008
Last updated: June 29, 2010
Last verified: June 2010
  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: Allocation: Non-Randomized
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 National Institute on Drug Abuse (NIDA):

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 ]

Estimated Enrollment: 60
Study Start Date: November 2005
Estimated Study Completion Date: August 2011
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Depot naltrexone
    Injectable naltrexone (228 mg) administered once monthly injected into the buttock, alternate sides of the buttock for up to six months months.
Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
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: NCT00756990

Locations
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Investigators
Principal Investigator: Charles O'Brien, MD,PhD University of Pennsylvania
  More Information

No publications provided

Responsible Party: Daniel D. Langleben, MD, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00756990     History of Changes
Other Study ID Numbers: 708310
Study First Received: September 19, 2008
Last Updated: June 29, 2010
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014