Trial · NCT04454411
Brain Mechanisms of Pharmacotherapy in Opioid Use Disorder
NCT04454411, Phase 2, Terminated, University of Pennsylvania; results first posted 2025-08-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Brain Mechanisms of Pharmacotherapy in Opioid Use Disorder. Trials, record NCT04454411. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04454411
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Brain Mechanisms of Pharmacotherapy in Opioid Use Disorder
- NCT number
- NCT04454411
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 3 participants, actual
- Lead sponsor
- University of Pennsylvania
- Conditions
- Opioid Dependence
- Interventions
- Brixadi, Vivitrol
- First posted
- 2020-07-01
- Last updated
- 2025-08-06
- Results first posted
- 2025-08-06
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | fMRI Signal | up to 90 days | Brain fMRI response to neurocognitive probes |
| Primary | Urine Toxicology: Opioid | Through the study completion, up to 120 days | 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 |
| Secondary | Anxiety | Through the study completion, up to 120 days | 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. |
| Secondary | Depression | Through the study completion, up to 120 days | 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. |
| Secondary | Non-opioid Urine Toxicology | Through the study completion, up to 120 days | 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\* |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | fMRI Signal | up to 90 days | 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. | ||
| PRIMARY | Urine Toxicology: Opioid | Through the study completion, up to 120 days | 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. | ||
| SECONDARY | Anxiety | Through the study completion, up to 120 days | 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. | ||
| SECONDARY | Depression | Through the study completion, up to 120 days | 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. | ||
| SECONDARY | Non-opioid Urine Toxicology | Through the study completion, up to 120 days | 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. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Buprenorphine | 0 | |
| Overall Study | STARTED | Naltrexone | 0 | |
| Overall Study | COMPLETED | Buprenorphine | 0 | |
| Overall Study | COMPLETED | Naltrexone | 0 | |
| Overall Study | NOT COMPLETED | Buprenorphine | 0 | |
| Overall Study | NOT COMPLETED | Naltrexone | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Buprenorphine | 0 | 0 |
| Total, all-cause mortality | Naltrexone | 0 | 0 |
| Total, other adverse events | Buprenorphine | 0 | 0 |
| Total, other adverse events | Naltrexone | 0 | 0 |
| Total, serious adverse events | Buprenorphine | 0 | 0 |
| Total, serious adverse events | Naltrexone | 0 | 0 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04454411
GET https://conductscience.org/api/trials/v1/NCT04454411/registered