Depot Naltrexone Treatment of Opioid Dependent Parolees

NCT00756990 | Completed DMC

• 1 other identifier: 708310
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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 .

Conditions

Opioid Dependence

Outcome Measures

Primary Outcomes (1)

• UDS results

  6 months

Secondary Outcomes (1)

• Treatment completion

  6 months

Study Arms (1)

Single group

EXPERIMENTAL

Depot Naltrexone

Drug: Depot Naltrexone

Interventions

Depot Naltrexone DRUG

228mg of injectable naltrexone

Also known as: Depotrex

Single group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Charles O'Brien, MD,PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2008
• First Posted: September 22, 2008
• Study Start: November 1, 2005
• Primary Completion: March 1, 2009
• Study Completion: August 1, 2011
• Last Updated: April 23, 2019

Record last verified: 2019-04

Locations

US (1)