NCT02324725

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Oct 2011

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

December 8, 2014

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 24, 2014

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

January 12, 2023

Status Verified

December 1, 2022

Enrollment Period

10.2 years

First QC Date

December 8, 2014

Last Update Submit

December 30, 2022

Conditions

Heroin DependenceOpioid Dependence

Keywords

naltrexoneneuroimagingheroinaddictiondependenceopioidVivitrol®functional magnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Cigarettes smoked per day

    6 months

  • Urine toxicology

    6 months

  • Injections

    3 months

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

    2 hours

Study Arms (1)

Naltrexone Intervention

EXPERIMENTAL

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.

Drug: Naltrexone

Interventions

NaltrexoneDRUG

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

Also known as: Vivitrol ®
Naltrexone Intervention

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for the Studies of Addiction

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • 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.

    PMID: 32379516DERIVED

MeSH Terms

Conditions

Heroin DependenceOpioid-Related DisordersBehavior, Addictive

Interventions

Naltrexonevivitrol

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersCompulsive BehaviorImpulsive BehaviorBehavior

Intervention Hierarchy (Ancestors)

NaloxoneMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Daniel Langleben, MD

    Co-Investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2014

First Posted

December 24, 2014

Study Start

October 1, 2011

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

January 12, 2023

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)