Status:
COMPLETED
Depot Naltrexone Treatment of Opioid Dependent Parolees
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Opioid Dependence
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
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...
Detailed Description
This is a two phase study. Phase 1 is complete and phase 2 is not yet recruiting.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT00756990
Start Date
November 1 2005
End Date
August 1 2011
Last Update
April 23 2019
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104