Biomarkers of Injectable Extended Release Naltrexone Treatment

Opioid Dependence Clinical Trial

Official title:

Biomarkers of Disease and Response to Treatment in Opioid Addiction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02324725
• Other study ID #: 814234
• Status: Completed
• Phase: Phase 4
• Start date: October 2011
• Est. completion date: December 2021

Study information

• Verified date: December 2022
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This study is using blood oxygenation level dependent (BOLD) functional magnetic resonance imaging (fMRI) to examine the brain predictors of adherence and outcomes of opioid antagonist therapy. Opioid-dependent intravenous heroin users are offered up to 3 monthly injections of the extended-release naltrexone (XRNTX) contingent upon successful outpatient non-opioid detoxification, with an additional 4 weeks of follow up. Brain responses to heroin-related pictures are recorded using fMRI prior to the 1st XRNTX injection and approximately 2 weeks thereafter the 1st XRNTX injection. Primary clinical variables include the number of injections (maximum of 3) accepted by participants, change in self-reported craving for opioids after exposure to drug-related visual cues during the brain fMRI sessions, urine levels of ten commonly abused substances and self-report of cigarette use.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Heroin Dependence
• Opioid Dependence
• Opioid-Related Disorders

Intervention

Drug:
• Naltrexone
Up to three monthly injections of 380 mg of naltrexone suspended in dissolvable polymer microspheres and administered intramuscularly

Locations

Country	Name	City	State
United States	Center for the Studies of Addiction	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brain response to heroin-related visual cues	Brain, behavioral and motivational (e.g. craving) response to audiovisual drug-related and control stimuli (images, smells and sounds) and to standard tasks of decision making, self-appraisal, response inhibition, social interaction and reward processing.	1 hour
Secondary	Cigarettes smoked per day	behavioral	6 months
Secondary	Urine toxicology	Urine toxicology for methamphetamine, amphetamines, cannabis, cocaine, oxycodone, buprenophine, methadone, opioids, benzodiazepines and barbiturates.	6 months
Secondary	Injections	Number of injections (maximum of 3) accepted by participants	3 months
Secondary	Motivational response to opioid-related visual cues measured by self-reported craving for opioids	Change in self-reported craving for opioids after exposure to opioid-related visual cues during functional MRI sessions	2 hours