CompletedPhase 4

Biomarkers of Injectable Extended Release Naltrexone Treatment

United States32 participantsStarted 2011-10

Plain-language summary

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.

Who can participate

Age range18 Years – 55 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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

What they're measuring

Brain response to heroin-related visual cues

Timeframe: 1 hour

Trial details

NCT IDNCT02324725

SponsorUniversity of Pennsylvania

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-12

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