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Biomarkers of Injectable Extended Release Naltrexone Treatment

Primary Purpose

Heroin Dependence, Opioid Dependence

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Naltrexone

About this trial

This is an interventional treatment trial for Heroin Dependence focused on measuring naltrexone, neuroimaging, heroin, addiction, dependence, opioid, Vivitrol®, functional magnetic resonance imaging

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Center for the Studies of Addiction

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Naltrexone Intervention

Arm Description

Eligible participants receive up to three monthly injections of 380 mg of naltrexone contained in dissolvable polymer microspheres and administered by deep intramuscular injection and slowly released over a period of approximately 4 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Cigarettes smoked per day

behavioral

Urine toxicology

Urine toxicology for methamphetamine, amphetamines, cannabis, cocaine, oxycodone, buprenophine, methadone, opioids, benzodiazepines and barbiturates.

Injections

Number of injections (maximum of 3) accepted by participants

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

Full Information

NCT ID

NCT02324725

First Posted

December 8, 2014

Last Updated

December 30, 2022

Sponsor

University of Pennsylvania

1. Study Identification

Unique Protocol Identification Number

NCT02324725

Brief Title

Biomarkers of Injectable Extended Release Naltrexone Treatment

Official Title

Biomarkers of Disease and Response to Treatment in Opioid Addiction

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Completed

Study Start Date

October 2011 (Actual)

Primary Completion Date

December 2021 (Actual)

Study Completion Date

December 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Pennsylvania

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heroin Dependence, Opioid Dependence

Keywords

naltrexone, neuroimaging, heroin, addiction, dependence, opioid, Vivitrol®, functional magnetic resonance imaging

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Naltrexone Intervention

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Naltrexone

Other Intervention Name(s)

Vivitrol ®

Intervention Description

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

Primary Outcome Measure Information:

Title

Brain response to heroin-related visual cues

Description

Time Frame

1 hour

Secondary Outcome Measure Information:

Title

Cigarettes smoked per day

Description

behavioral

Time Frame

6 months

Title

Urine toxicology

Description

Urine toxicology for methamphetamine, amphetamines, cannabis, cocaine, oxycodone, buprenophine, methadone, opioids, benzodiazepines and barbiturates.

Time Frame

6 months

Title

Injections

Description

Number of injections (maximum of 3) accepted by participants

Time Frame

3 months

Title

Motivational response to opioid-related visual cues measured by self-reported craving for opioids

Description

Change in self-reported craving for opioids after exposure to opioid-related visual cues during functional MRI sessions

Time Frame

2 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Daniel Langleben, MD

Organizational Affiliation

Co-Investigator

Official's Role

Principal Investigator

Facility Information:

Facility Name

Center for the Studies of Addiction

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32379516

Citation

Wang AL, Shi Z, Elman I, Langleben DD. Reduced cigarette smoking during injectable extended-release naltrexone treatment for opioid use disorder. Am J Drug Alcohol Abuse. 2020 Jul 3;46(4):472-477. doi: 10.1080/00952990.2020.1741001. Epub 2020 May 7. Erratum In: Am J Drug Alcohol Abuse. 2020 Jul 3;46(4):512.

Results Reference

derived

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Biomarkers of Injectable Extended Release Naltrexone Treatment

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