Depot Naltrexone Treatment of Opioid Dependent Parolees

Opioid Dependence Clinical Trial

Official title:

Depot Naltrexone Treatment of Opioid Dependent Parolees

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00756990
• Other study ID #: 708310
• Status: Completed
• Phase: N/A
• Start date: November 2005
• Est. completion date: August 2011

Study information

• Verified date: April 2019
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: August 2011
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Opioid Dependence
• Opioid-Related Disorders

Intervention

Drug:
• Depot Naltrexone
228mg of injectable naltrexone

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	UDS results		6 months
Secondary	Treatment completion		6 months