Overview

Biomarkers of Injectable Extended Release Naltrexone Treatment

Status:
Active, not recruiting
Trial end date:
2022-10-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Pennsylvania
Treatments:
Naltrexone
Criteria
Inclusion Criteria:

1. 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

2. urine toxicology screen negative for opioids after detoxification

3. good physical health as indicated by history and physical examination, screening blood
work-up and urinalysis.

Exclusion Criteria:

1. chronic medical illnesses;

2. current use of medications potentially confounding brain activity, such as
anti-dopaminergic agents, anti-depressants and beta-blockers;

3. current DSM-IV-TR Axis I psychiatric disorders other than opioid and nicotine
dependence;

4. life time history of concurrent IV cocaine and heroin (speedball) administration;

5. pregnancy or breastfeeding;

6. history of clinically significant head trauma;

7. 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

8. contraindications for MRI, i.e. indwelling magnetically active foreign bodies and
phobia to enclosed spaces