Heroin DependencePhase 4NCT02324725
Biomarkers of Injectable Extended Release Naltrexone Treatment
A Phase 4 study testing Naltrexone in people with Heroin Dependence and Opioid Dependence, run by University of Pennsylvania at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Heroin Dependence, Opioid Dependence
- What is being tested?
- Naltrexone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Dec 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for the Studies of Addiction
Philadelphia, Pennsylvania, 19104
About this study
Official title: Biomarkers of Disease and Response to Treatment in Opioid Addiction
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.
Read the 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
- Being tested
- Naltrexone
- Keywords
- naltrexone, neuroimaging, heroin, addiction, dependence, opioid, Vivitrol®, functional magnetic resonance imaging
- Medical subject headings
- Heroin Dependence, Opioid-Related Disorders, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaltrexoneDrug
Also called Vivitrol ®
Up to three monthly injections of 380 mg of naltrexone suspended in dissolvable polymer microspheres and administered intramuscularly
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Naltrexone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour
Secondary outcomes (4)
Cigarettes smoked per day
behavioral
Measured: 6 months
Urine toxicology
Urine toxicology for methamphetamine, amphetamines, cannabis, cocaine, oxycodone, buprenophine, methadone, opioids, benzodiazepines and barbiturates.
Measured: 6 months
Injections
Number of injections (maximum of 3) accepted by participants
Measured: 3 months
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
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2014 (estimated)
- Study startOct 2011
- Primary completionDec 2021
- Study completionDec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heroin DependenceStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Langleben, MD, Principal investigator, Co-Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02324725
- Sponsor's protocol ID
- 814234
- Status last verified
- Dec 2022
- First submitted
- 8 Dec 2014
- Last updated
- 12 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 32379516
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers of Disease and Response to Treatment in Opioid Addiction
- ClinicalTrials.gov ID
- NCT02324725
- Acronym / sponsor ID
- 814234
- Conditions
- Heroin Dependence, Opioid Dependence
- Keywords
- naltrexone, neuroimaging, heroin, addiction, dependence, opioid, Vivitrol®, functional magnetic resonance imaging
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Oct 2011 (actual)
- Primary completion
- Dec 2021 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 24 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Naltrexone Intervention | Experimental | Drug: NaltrexoneEligible 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NaltrexoneAlso: Vivitrol ®Up to three monthly injections of 380 mg of naltrexone suspended in dissolvable polymer microspheres and administered intramuscularly | Drug | Naltrexone Intervention |
Primary outcome
Brain response to heroin-related visual cues
Time frame: 1 hour
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.
4 secondary outcomes
Cigarettes smoked per day
Time frame: 6 months
Urine toxicology
Time frame: 6 months
Injections
Time frame: 3 months
Motivational response to opioid-related visual cues measured by self-reported craving for opioids
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2023.
- Derived from this study: PubMed 32379516Wang 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Langleben, MD principal investigator
Co-Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Naltrexone in people with Heroin Dependence and Opioid Dependence, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain response to heroin-related visual cues (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02324725, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2023.