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Depot Naltrexone Treatment of Opioid Dependent Parolees

Primary Purpose

Opioid Dependence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Depot Naltrexone
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid Dependence

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Pennsylvania

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single group

Arm Description

Depot Naltrexone

Outcomes

Primary Outcome Measures

UDS results

Secondary Outcome Measures

Treatment completion

Full Information

First Posted
September 19, 2008
Last Updated
April 19, 2019
Sponsor
University of Pennsylvania
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00756990
Brief Title
Depot Naltrexone Treatment of Opioid Dependent Parolees
Official Title
Depot Naltrexone Treatment of Opioid Dependent Parolees
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single group
Arm Type
Experimental
Arm Description
Depot Naltrexone
Intervention Type
Drug
Intervention Name(s)
Depot Naltrexone
Other Intervention Name(s)
Depotrex
Intervention Description
228mg of injectable naltrexone
Primary Outcome Measure Information:
Title
UDS results
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Treatment completion
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles O'Brien, MD,PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Depot Naltrexone Treatment of Opioid Dependent Parolees

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