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The proposed project will use fMRI and specific probes of reward and inhibition as biomarkers predicting drug use during and after treatment in 72 subjects addicted to prescription opioids/medications. Subjects will be scanned before, during, and after 12 weeks of active medication. The brain fMRI measures will be correlated with the primary clinical outcome of drug use (by urine drug screen) during the treatment and follow-up phase.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vivitrol | Drug | There are monthly injections of depot naltrexone for 3 months. |
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| Measure | Description | Time Frame |
|---|---|---|
| Illicit-positive Urines During Treatment and Follow-up | three months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Langleben, MD | Co-Investigator | Principal Investigator |
| Anna R Childress, MD | Principal Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania Addiction Treatment Research Center | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32379516 | Derived | 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. |
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50 individuals were lost to attrition. 4 individuals withdrew from the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Vivitrol: There are monthly injections of depot naltrexone for 3 months. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Vivitrol: There are monthly injections of depot naltrexone for 3 months. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Illicit-positive Urines During Treatment and Follow-up | Individuals were tested for presence of opioids: buprenorphine, methadone, opioids, and oxycontin within their urine toxicology | Posted | Count of Participants | Participants | three months |
|
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72 subjects addicted to prescription opioids/medications were scanned before, during, and after 12 weeks of active medication. Participants will receive three injections over three months then be observed for an additional three months
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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 | 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. Vivitrol: There are monthly injections of depot naltrexone for 3 months. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel Langleben, MD | University of Pennsylvania | 215-760-7067 | langlebe@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 | Jun 16, 2014 | Jul 10, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C000624616 | vivitrol |
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| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Participants |
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| 0 |
| 72 |
| 0 |
| 72 |
| 0 |
| 72 |
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| Negative Urine Test |
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| Negative Urine Test |
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