Trial Outcomes & Findings for Brain Mechanisms of Pharmacotherapy in Opioid Use Disorder (NCT NCT04454411)
NCT ID: NCT04454411
Last Updated: 2025-08-06
Results Overview
Brain fMRI response to neurocognitive probes
TERMINATED
PHASE2
3 participants
up to 90 days
2025-08-06
Participant Flow
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.
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.
Participant milestones
| Measure |
Buprenorphine
Participants assigned to treatment with extended-release buprenorphine
Brixadi: Extended release injectable Buprenorphine
|
Naltrexone
Participants assigned to treatment with extended-release naltrexone
Vivitrol: Extended release injectable Naltrexone
|
|---|---|---|
|
Overall Study
STARTED
|
0
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Brain Mechanisms of Pharmacotherapy in Opioid Use Disorder
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: up to 90 daysPopulation: 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.
Brain fMRI response to neurocognitive probes
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Through the study completion, up to 120 daysPopulation: 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.
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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through the study completion, up to 120 daysPopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through the study completion, up to 120 daysPopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Through the study completion, up to 120 daysPopulation: 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.
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\*
Outcome measures
Outcome data not reported
Adverse Events
Buprenorphine
Naltrexone
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place