This trial is active, not recruiting.

Condition opioid dependence
Treatment depot naltrexone
Sponsor National Institute on Drug Abuse (NIDA)
Start date November 2005
End date March 2009
Trial size 60 participants
Trial identifier NCT00756990, 708310


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 .

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

UDS results
time frame: 6 months

Secondary Outcomes

Treatment completion
time frame: 6 months

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

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.

Additional Information

Official title Depot Naltrexone Treatment of Opioid Dependent Parolees
Principal investigator Charles O'Brien, MD,PhD
Description This is a two phase study. Phase 1 is complete and phase 2 is not yet recruiting.
Trial information was received from ClinicalTrials.gov and was last updated in June 2010.
Information provided to ClinicalTrials.gov by National Institute on Drug Abuse (NIDA).