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Primary funding source has ended.
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This study will investigate the mechanisms of cognitive-behavioral response to medications used for relapse prevention in opioid use disorder (opioid addiction, OUD), through investigation of the neural circuits underlying key cognition functions. The study will use previously validated cognitive probes, functional Magnetic Resonance Imaging (fMRI), and novel extended-release injectable preparations of opioid partial agonist buprenorphine and antagonist naltrexone, in OUD patients to explain the individual heterogeneity of OUD treatment response.
This proposal seeks to identify the neural circuits underlying the cognitive effects of medication assisted therapy (MAT) for OUD. The study will examine the neurocognitive effects of MAT by comparing two preparations with different pharmacodynamic properties (extended release buprenorphine and naltrexone, XRBUP, XRNTX) in three key domains (incentive salience, executive functioning, and emotion processing) using task functional Magnetic Resonance Imaging (MRI). In the 1st phase of the study, forty treatment-seeking OUD patients will be randomized to XRNTX or XRBUP groups after detoxification. Participants will undergo medication induction followed by monthly injections and urine toxicology monitoring for 120 days. Neuroimaging will follow completion of detoxification (pre-treatment) and 15 days after the second injection (on-treatment). The second study phase will extend the paradigm to an independent sample of 160 additional participants and test the explanatory value of MAT-induced changes in the neuroimaging signal in the classification of OUD treatment outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Buprenorphine | Experimental | Participants assigned to treatment with extended-release buprenorphine |
|
| Naltrexone | Active Comparator | Participants assigned to treatment with extended-release naltrexone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brixadi | Drug | Extended release injectable Buprenorphine |
|
| Measure | Description | Time Frame |
|---|---|---|
| fMRI Signal | Brain fMRI response to neurocognitive probes | up to 90 days |
| Urine Toxicology: Opioid | Rapid semi-quantitative ELISA urine drug screen test for morphine, oxycodone and methadone, followed by (cut off levels): Methadone (MTD) Methadone 300 ng/mL Opiates (OPI 300) Morphine Morphine **300 ng/mL Oxycodone (OXY) Oxycodone 100 ng/mL | Through the study completion, up to 120 days |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety | Hamilton Anxiety Rating Scale (HAM-A) (Hamilton, 1967). The HAM-A is a 15-minute, 14-item, clinician-administered instrument that measures current anxiety and changes in anxiety symptoms. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. | Through the study completion, up to 120 days |
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Inclusion Criteria:
Exclusion Criteria:
Psychiatric Co-morbidities:
Contraindications for XRNTX or XRBUP e.g. active liver disease.
Medical and surgical conditions such as malignancy that may affect patients' ability to receive XRNTX or XRBUP treatment because it may interfere with opioid analgesia
Contraindications for MRI, e.g. claustrophobia, indwelling foreign magnetic agents.
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| Name | Affiliation | Role |
|---|---|---|
| James Loughead, Ph.D. | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 3535 Market Street, Suite 4100, University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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One of the consented individuals was later excluded due to risk of metal fragments in the body. Two participants were lost to follow-up prior to randomization.
143 individuals contacted the study staff expressing interest in phone screening. Of these, 28 individuals completed phone screening and three were eligible for the study and consented. One of the consented individuals was later excluded due to risk of metal fragments in the body. Two participants were lost to follow-up prior to randomization.
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| ID | Title | Description |
|---|---|---|
| FG000 | Buprenorphine | Participants assigned to treatment with extended-release buprenorphine Brixadi: Extended release injectable Buprenorphine |
| FG001 | Naltrexone | Participants assigned to treatment with extended-release naltrexone Vivitrol: Extended release injectable Naltrexone |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
143 individuals contacted the study staff expressing interest in phone screening. Of these, 28 individuals completed phone screening and three were eligible for the study and consented. One of the consented individuals was later excluded due to risk of metal fragments in the body. Two participants were lost to follow-up prior to randomization.
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| ID | Title | Description |
|---|---|---|
| BG000 | Buprenorphine | Participants assigned to treatment with extended-release buprenorphine Brixadi: Extended release injectable Buprenorphine |
| BG001 | Naltrexone | Participants assigned to treatment with extended-release naltrexone Vivitrol: Extended release injectable Naltrexone |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | fMRI Signal | Brain fMRI response to neurocognitive probes | 143 individuals contacted the study staff expressing interest in phone screening. Of these, 28 individuals completed phone screening and three were eligible for the study and consented. One of the consented individuals was later excluded due to risk of metal fragments in the body. Two participants were lost to follow-up prior to randomization. | Posted | up to 90 days |
|
1 year
143 individuals contacted the study staff expressing interest in phone screening. Of these, 28 individuals completed phone screening and three were eligible for the study and consented. One of the consented individuals was later excluded due to risk of metal fragments in the body. Two participants were lost to follow-up prior to randomization.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Buprenorphine | Participants assigned to treatment with extended-release buprenorphine Brixadi: Extended release injectable Buprenorphine |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James Loughead, Ph.D. | University of Pennsylvania | 215-205-1876 | loughead@pennmedicine.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 17, 2023 | May 29, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D002047 | Buprenorphine |
| C000624616 | vivitrol |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Vivitrol | Drug | Extended release injectable Naltrexone |
|
|
| Depression | Hamilton Depression Rating Scale (HAM-D) (Hamilton, 1959 #2497). The HAM-D is a 20-minute, 24-item interview that measures the severity of depression and changes in depressive symptoms. HAM-D form includes 21 items, however the scoring is based on the first 17. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2. The HAM-D score level corresponds to the clinical severity of depression as follows: 10 - 13 mild; 14-17 mild to moderate; >17 moderate to severe. | Through the study completion, up to 120 days |
| Non-opioid Urine Toxicology | Rapid semi-quantitative ELISA urine drug screen test for amphetamine/methamphetamine, benzodiazepines, cocaine, phencyclidine, cannabinoids and cotinine, with cut off levels: Amphetamine/Methamphetamine 500/1000ng/ml Benzodiazepines Enzyme Immunoassay (EIA) 200 ng/mL Cocaine Metabolite (Benzoylecgonine) EIA 150/300 ng/mL Cotinine EIA 250 ng/mL Phencyclidine EIA 25 ng/mL THC (Cannabinoids) EIA 20/50 ng/mL* | Through the study completion, up to 120 days |
| BG002 | Total | Total of all reporting groups |
| Sex: Female, Male |
|
| Ethnicity (NIH/OMB) |
|
| Race (NIH/OMB) |
|
| COWS |
|
| Primary | Urine Toxicology: Opioid | Rapid semi-quantitative ELISA urine drug screen test for morphine, oxycodone and methadone, followed by (cut off levels): Methadone (MTD) Methadone 300 ng/mL Opiates (OPI 300) Morphine Morphine **300 ng/mL Oxycodone (OXY) Oxycodone 100 ng/mL | 143 individuals contacted the study staff expressing interest in phone screening. Of these, 28 individuals completed phone screening and three were eligible for the study and consented. One of the consented individuals was later excluded due to risk of metal fragments in the body. Two participants were lost to follow-up prior to randomization. | Posted | Through the study completion, up to 120 days |
|
|
| Secondary | Anxiety | Hamilton Anxiety Rating Scale (HAM-A) (Hamilton, 1967). The HAM-A is a 15-minute, 14-item, clinician-administered instrument that measures current anxiety and changes in anxiety symptoms. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. | 143 individuals contacted the study staff expressing interest in phone screening. Of these, 28 individuals completed phone screening and three were eligible for the study and consented. One of the consented individuals was later excluded due to risk of metal fragments in the body. Two participants were lost to follow-up prior to randomization. | Posted | Through the study completion, up to 120 days |
|
|
| Secondary | Depression | Hamilton Depression Rating Scale (HAM-D) (Hamilton, 1959 #2497). The HAM-D is a 20-minute, 24-item interview that measures the severity of depression and changes in depressive symptoms. HAM-D form includes 21 items, however the scoring is based on the first 17. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2. The HAM-D score level corresponds to the clinical severity of depression as follows: 10 - 13 mild; 14-17 mild to moderate; >17 moderate to severe. | 143 individuals contacted the study staff expressing interest in phone screening. Of these, 28 individuals completed phone screening and three were eligible for the study and consented. One of the consented individuals was later excluded due to risk of metal fragments in the body. Two participants were lost to follow-up prior to randomization. | Posted | Through the study completion, up to 120 days |
|
|
| Secondary | Non-opioid Urine Toxicology | Rapid semi-quantitative ELISA urine drug screen test for amphetamine/methamphetamine, benzodiazepines, cocaine, phencyclidine, cannabinoids and cotinine, with cut off levels: Amphetamine/Methamphetamine 500/1000ng/ml Benzodiazepines Enzyme Immunoassay (EIA) 200 ng/mL Cocaine Metabolite (Benzoylecgonine) EIA 150/300 ng/mL Cotinine EIA 250 ng/mL Phencyclidine EIA 25 ng/mL THC (Cannabinoids) EIA 20/50 ng/mL* | 143 individuals contacted the study staff expressing interest in phone screening. Of these, 28 individuals completed phone screening and three were eligible for the study and consented. One of the consented individuals was later excluded due to risk of metal fragments in the body. Two participants were lost to follow-up prior to randomization. | Posted | Through the study completion, up to 120 days |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Naltrexone | Participants assigned to treatment with extended-release naltrexone Vivitrol: Extended release injectable Naltrexone | 0 | 0 | 0 | 0 | 0 | 0 |
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| D006572 |
| Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |