Depot Naltrexone Treatment of Opioid Dependent Parolees

NCT ID: NCT00756990

Last Updated: 2019-04-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-11-30
• Study Completion Date: 2011-08-31

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 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 .

Detailed Description

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

Conditions

Opioid Dependence

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single group

Depot Naltrexone

Group Type: EXPERIMENTAL

Depot Naltrexone

Intervention Type: DRUG

228mg of injectable naltrexone

Interventions

Depot Naltrexone

228mg of injectable naltrexone

Intervention Type: DRUG

Other Intervention Names

Depotrex

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charles O'Brien, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

708310

Identifier Type: -

Identifier Source: org_study_id