Biomarkers of Injectable Extended Release Naltrexone Treatment

Completed · Phase 4

Conditions studied: Heroin Dependence, Opioid Dependence

In brief

This study evaluates the biological markers of treatment of opioid dependent individuals with an extended release formulation of the opioid antagonist naltrexone. The biological measures include functional MRI, blood levels of naltrexone and its metabolites, urine toxicology and behavioral tests probing various aspects of personality, memory, reward processing and attention.

Key facts

Study ID

NCT02324725

Run by

University of Pennsylvania

People needed

32

Starts

2011-10-01

Expected to finish

2021-12-01

Last updated by the study team

2023-01-12

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• DSM-IV-TR diagnosis of opioid dependence, active opioid use, confirmed by urine toxicology screen and self-reported monthly intravenous heroin use for more than 2 weeks in the past 3 months
• urine toxicology screen negative for opioids after detoxification
• good physical health as indicated by history and physical examination, screening blood work-up and urinalysis.

You may not qualify if…

• chronic medical illnesses;
• current use of medications potentially confounding brain activity, such as anti-dopaminergic agents, anti-depressants and beta-blockers;
• current DSM-IV-TR Axis I psychiatric disorders other than opioid and nicotine dependence;
• life time history of concurrent IV cocaine and heroin (speedball) administration;
• pregnancy or breastfeeding;
• history of clinically significant head trauma;
• contraindications for naltrexone treatment including medical conditions requiring opioid analgesics, e.g. chronic pain or planned surgery, obesity, elevated liver enzymes (> 3 times upper limit of normal), failure to complete opioid detoxification
• contraindications for MRI, i.e. indwelling magnetically active foreign bodies and phobia to enclosed spaces

Where it is running

• Center for the Studies of Addiction — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.