Depot Naltrexone Treatment of Opioid Dependent Parolees
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by National Institute on Drug Abuse (NIDA).
Recruitment status was Active, not recruiting
Information provided by:
National Institute on Drug Abuse (NIDA)
First received: September 19, 2008
Last updated: June 29, 2010
Last verified: June 2010
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 .
Drug: Depot naltrexone
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Depot Naltrexone Treatment of Opioid Dependent Parolees
Primary Outcome Measures:
- UDS results [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Treatment completion [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Primary Completion Date:
||March 2009 (Final data collection date for primary outcome measure)
Drug: Depot naltrexone
Injectable naltrexone (228 mg) administered once monthly injected into the buttock, alternate sides of the buttock for up to six months months.
This is a two phase study. Phase 1 is complete and phase 2 is not yet recruiting.
|Ages Eligible for Study:
||18 Years to 55 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00756990
|University of Pennsylvania
|Philadelphia, Pennsylvania, United States, 19104 |
||Charles O'Brien, MD,PhD
||University of Pennsylvania
No publications provided
||Daniel D. Langleben, MD, University of Pennsylvania
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 19, 2008
||June 29, 2010
||United States: Federal Government
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 26, 2014
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Central Nervous System Depressants