Biomarkers of Injectable Extended Release Naltrexone Treatment

NCT ID: NCT02324725

Last Updated: 2023-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2021-12-31

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.

Conditions

Heroin Dependence; Opioid Dependence

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Naltrexone Intervention

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.

Group Type: EXPERIMENTAL

Naltrexone

Intervention Type: DRUG

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

Interventions

Naltrexone

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

Intervention Type: DRUG

Other Intervention Names

Vivitrol ®

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Langleben, MD

Role: PRINCIPAL_INVESTIGATOR

Co-Investigator

Locations

Center for the Studies of Addiction

Philadelphia, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 32379516 (View on PubMed)

Other Identifiers

814234

Identifier Type: -

Identifier Source: org_study_id