| Primary | ED-15 Score | ED-15 is an evidenced-based metric of eating disorder symptom severity and frequency. The global score ranges from a 0 to 6 with higher scores indicating more eating disordered psychopathology. | Numbers represent participants enrolled at this time point. | Posted | | Mean | Standard Deviation | score on a scale | | Time Frame: Measured at the following timepoints: enrollment | | | | ID | Title | Description |
|---|
| OG000 | Intervention | Oral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler Naltrexone Hydrochloride: 25mg x 3 days then 50mg a day thereafter | | OG001 | Control | Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0003.5± 2.016184515
- OG0014.7± 0.871779789
|
|
| |
| Primary | ED-15 Score | ED-15 is an evidenced-based metric of eating disorder symptom severity and frequency. The global score ranges from a 0 to 6 with higher scores indicating more eating disordered psychopathology. | Numbers represent participants enrolled at this time point. | Posted | | Mean | Standard Deviation | score on a scale | | Time Frame: Measured at the following timepoints: one week | | | | ID | Title | Description |
|---|
| OG000 | Intervention | Oral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler Naltrexone Hydrochloride: 25mg x 3 days then 50mg a day thereafter | | OG001 | Control | Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only |
| |
| Primary | ED-15 Score | ED-15 is an evidenced-based metric of eating disorder symptom severity and frequency. The global score ranges from a 0 to 6 with higher scores indicating more eating disordered psychopathology. | Numbers represent participants enrolled at this time point. | Posted | | Mean | Standard Deviation | score on a scale | | Time Frame: Measured at the following timepoints: three week | | | | ID | Title | Description |
|---|
| OG000 | Intervention | Oral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler Naltrexone Hydrochloride: 25mg x 3 days then 50mg a day thereafter | | OG001 | Control | Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only |
| |
| Primary | ED-15 Score | ED-15 is an evidenced-based metric of eating disorder symptom severity and frequency. The global score ranges from a 0 to 6 with higher scores indicating more eating disordered psychopathology. | Numbers represent participants enrolled at this time point, other participants were lost to follow-up. | Posted | | Mean | Standard Deviation | score on a scale | | Time Frame: Measured at the following timepoints: six weeks | | | | ID | Title | Description |
|---|
| OG000 | Intervention | Oral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler Naltrexone Hydrochloride: 25mg x 3 days then 50mg a day thereafter | | OG001 | Control | Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only |
| |
| Primary | ED-15 Score | ED-15 is an evidenced-based metric of eating disorder symptom severity and frequency. The global score ranges from a 0 to 6 with higher scores indicating more eating disordered psychopathology. | Numbers represent participants enrolled at this time point, other participants were lost to follow-up. | Posted | | Mean | Standard Deviation | score on a scale | | Time Frame: Measured at the following timepoints: nine weeks (last week of treatment) | | | | ID | Title | Description |
|---|
| OG000 | Intervention | Oral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler Naltrexone Hydrochloride: 25mg x 3 days then 50mg a day thereafter | | OG001 | Control | Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only |
| |
| Primary | ED-15 Score | ED-15 is an evidenced-based metric of eating disorder symptom severity and frequency. The global score ranges from a 0 to 6 with higher scores indicating more eating disordered psychopathology. | Numbers represent participants enrolled at this time point, other participants were lost to follow-up. | Posted | | Mean | Standard Deviation | score on a scale | | Time Frame: Measured at the following timepoints: 6 months after enrollment | | | | ID | Title | Description |
|---|
| OG000 | Intervention | Oral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler Naltrexone Hydrochloride: 25mg x 3 days then 50mg a day thereafter | | OG001 | Control | Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only |
| |
| Secondary | Eating Disorder Examination Questionnaire Score (EDE-Q) | EDE-Q is an evidence-based metric of eating disorder severity. The global EDE-Q score ranges from 0 to 6, with higher scores indicating a higher eating disorder psychopathology. | Numbers represent participants enrolled at this time point. | Posted | | Mean | Standard Deviation | score on a scale | | Measured at the following timepoints: enrollment | | | | ID | Title | Description |
|---|
| OG000 | Intervention | Oral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler Naltrexone Hydrochloride: 25mg x 3 days then 50mg a day thereafter | | OG001 | Control | Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only |
| |
| Secondary | Eating Disorder Examination Questionnaire Score (EDE-Q) | EDE-Q is an evidence-based metric of eating disorder severity. The global EDE-Q score ranges from 0 to 6, with higher scores indicating a higher eating disorder psychopathology. | Numbers represent participants enrolled at this time point. | Posted | | Mean | Standard Deviation | score on a scale | | Measured at the following timepoints: one week | | | | ID | Title | Description |
|---|
| OG000 | Intervention | Oral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler Naltrexone Hydrochloride: 25mg x 3 days then 50mg a day thereafter | | OG001 | Control | Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only |
| |
| Secondary | Eating Disorder Examination Questionnaire Score (EDE-Q) | EDE-Q is an evidence-based metric of eating disorder severity. The global EDE-Q score ranges from 0 to 6, with higher scores indicating a higher eating disorder psychopathology. | Numbers represent participants enrolled at this time point. | Posted | | Mean | Standard Deviation | score on a scale | | Measured at the following timepoints: three weeks | | | | ID | Title | Description |
|---|
| OG000 | Intervention | Oral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler Naltrexone Hydrochloride: 25mg x 3 days then 50mg a day thereafter | | OG001 | Control | Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only |
| |
| Secondary | Eating Disorder Examination Questionnaire Score (EDE-Q) | EDE-Q is an evidence-based metric of eating disorder severity. The global EDE-Q score ranges from 0 to 6, with higher scores indicating a higher eating disorder psychopathology. | Numbers represent participants enrolled at this time point, other participants were lost to follow-up. | Posted | | Mean | Standard Deviation | score on a scale | | Measured at the following timepoints: six weeks | | | | ID | Title | Description |
|---|
| OG000 | Intervention | Oral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler Naltrexone Hydrochloride: 25mg x 3 days then 50mg a day thereafter | | OG001 | Control | Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only |
| |
| Secondary | Eating Disorder Examination Questionnaire Score (EDE-Q) | EDE-Q is an evidence-based metric of eating disorder severity. The global EDE-Q score ranges from 0 to 6, with higher scores indicating a higher eating disorder psychopathology. | Numbers represent participants enrolled at this time point, other participants were lost to follow-up. | Posted | | Mean | Standard Deviation | score on a scale | | Measured at the following timepoints: nine weeks (last week of treatment) | | | | ID | Title | Description |
|---|
| OG000 | Intervention | Oral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler Naltrexone Hydrochloride: 25mg x 3 days then 50mg a day thereafter | | OG001 | Control | Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only |
| |
| Secondary | Eating Disorder Examination Questionnaire Score (EDE-Q) | EDE-Q is an evidence-based metric of eating disorder severity. The global EDE-Q score ranges from 0 to 6, with higher scores indicating a higher eating disorder psychopathology. | Numbers represent participants enrolled at this time point, other participants were lost to follow-up. | Posted | | Mean | Standard Deviation | score on a scale | | Measured at the following timepoints: 6 months after enrollment | | | | ID | Title | Description |
|---|
| OG000 | Intervention | Oral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler Naltrexone Hydrochloride: 25mg x 3 days then 50mg a day thereafter | | OG001 | Control | Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only |
| |
| Secondary | Patient Health Questionnaire Score (PHQ-9) | Evidence-based metric of depression, min = 0, max= 27, higher scores indicate more severe depression | Numbers represent participants enrolled at this time point. | Posted | | Mean | Standard Deviation | score on a scale | | Measured at the following timepoints: enrollment | | | | ID | Title | Description |
|---|
| OG000 | Intervention | Oral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler Naltrexone Hydrochloride: 25mg x 3 days then 50mg a day thereafter | | OG001 | Control | Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only |
| |
| Secondary | Patient Health Questionnaire Score (PHQ-9) | Evidence-based metric of depression, min = 0, max= 27, higher scores indicate more severe depression | Numbers represent participants enrolled at this time point. | Posted | | Mean | Standard Deviation | score on a scale | | Measured at the following timepoints: one week | | | | ID | Title | Description |
|---|
| OG000 | Intervention | Oral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler Naltrexone Hydrochloride: 25mg x 3 days then 50mg a day thereafter | | OG001 | Control | Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only |
| |
| Secondary | Patient Health Questionnaire Score (PHQ-9) | Evidence-based metric of depression, min = 0, max= 27, higher scores indicate more severe depression | Numbers represent participants enrolled at this time point. | Posted | | Mean | Standard Deviation | score on a scale | | Measured at the following timepoints: three weeks | | | | ID | Title | Description |
|---|
| OG000 | Intervention | Oral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler Naltrexone Hydrochloride: 25mg x 3 days then 50mg a day thereafter | | OG001 | Control | Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only |
| |
| Secondary | Patient Health Questionnaire Score (PHQ-9) | Evidence-based metric of depression, min = 0, max= 27, higher scores indicate more severe depression | Numbers represent participants enrolled at this time point, other participants were lost to follow-up. | Posted | | Mean | Standard Deviation | score on a scale | | Measured at the following timepoints: six weeks | | | | ID | Title | Description |
|---|
| OG000 | Intervention | Oral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler Naltrexone Hydrochloride: 25mg x 3 days then 50mg a day thereafter | | OG001 | Control | Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only |
| |
| Secondary | Patient Health Questionnaire Score (PHQ-9) | Evidence-based metric of depression, min = 0, max= 27, higher scores indicate more severe depression | Numbers represent participants enrolled at this time point, other participants were lost to follow-up. | Posted | | Mean | Standard Deviation | score on a scale | | Measured at the following timepoints: nine weeks (last week of treatment) | | | | ID | Title | Description |
|---|
| OG000 | Intervention | Oral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler Naltrexone Hydrochloride: 25mg x 3 days then 50mg a day thereafter | | OG001 | Control | Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only |
| |
| Secondary | Patient Health Questionnaire Score (PHQ-9) | Evidence-based metric of depression, min = 0, max= 27, higher scores indicate more severe depression | Numbers represent participants enrolled at this time point, other participants were lost to follow-up. | Posted | | Mean | Standard Deviation | score on a scale | | Measured at the following timepoints: 6 months after enrollment | | | | ID | Title | Description |
|---|
| OG000 | Intervention | Oral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler Naltrexone Hydrochloride: 25mg x 3 days then 50mg a day thereafter | | OG001 | Control | Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only |
| |
| Secondary | Generalized Anxiety Disorder Screener Score (GAD-7) | evidence-based metric of anxiety, min=0, max=21, higher scores indicate more severe anxiety | Numbers represent participants enrolled at this time point. | Posted | | Mean | Standard Deviation | score on a scale | | Measured at the following timepoints: enrollment | | | | ID | Title | Description |
|---|
| OG000 | Intervention | Oral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler Naltrexone Hydrochloride: 25mg x 3 days then 50mg a day thereafter | | OG001 | Control | Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only |
| |
| Secondary | Generalized Anxiety Disorder Screener Score (GAD-7) | evidence-based metric of anxiety, min=0, max=21, higher scores indicate more severe anxiety | Numbers represent participants enrolled at this time point. | Posted | | Mean | Standard Deviation | score on a scale | | Measured at the following timepoints: one week | | | | ID | Title | Description |
|---|
| OG000 | Intervention | Oral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler Naltrexone Hydrochloride: 25mg x 3 days then 50mg a day thereafter | | OG001 | Control | Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only |
| |
| Secondary | Generalized Anxiety Disorder Screener Score (GAD-7) | evidence-based metric of anxiety, min=0, max=21, higher scores indicate more severe anxiety | Numbers represent participants enrolled at this time point. | Posted | | Mean | Standard Deviation | score on a scale | | Measured at the following timepoints: three weeks | | | | ID | Title | Description |
|---|
| OG000 | Intervention | Oral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler Naltrexone Hydrochloride: 25mg x 3 days then 50mg a day thereafter | | OG001 | Control | Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only |
| |
| Secondary | Generalized Anxiety Disorder Screener Score (GAD-7) | evidence-based metric of anxiety, min=0, max=21, higher scores indicate more severe anxiety | Numbers represent participants enrolled at this time point, other participants were lost to follow-up. | Posted | | Mean | Standard Deviation | score on a scale | | Measured at the following timepoints: six weeks | | | | ID | Title | Description |
|---|
| OG000 | Intervention | Oral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler Naltrexone Hydrochloride: 25mg x 3 days then 50mg a day thereafter | | OG001 | Control | Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only |
| |
| Secondary | Generalized Anxiety Disorder Screener Score (GAD-7) | evidence-based metric of anxiety, min=0, max=21, higher scores indicate more severe anxiety | Numbers represent participants enrolled at this time point, other participants were lost to follow-up. | Posted | | Mean | Standard Deviation | score on a scale | | Measured at the following timepoints: nine weeks (last week of treatment) | | | | ID | Title | Description |
|---|
| OG000 | Intervention | Oral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler Naltrexone Hydrochloride: 25mg x 3 days then 50mg a day thereafter | | OG001 | Control | Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only |
| |
| Secondary | Generalized Anxiety Disorder Screener Score (GAD-7) | evidence-based metric of anxiety, min=0, max=21, higher scores indicate more severe anxiety | Numbers represent participants enrolled at this time point, other participants were lost to follow-up. | Posted | | Mean | Standard Deviation | score on a scale | | Measured at the following timepoints: 6 months after enrollment | | | | ID | Title | Description |
|---|
| OG000 | Intervention | Oral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler Naltrexone Hydrochloride: 25mg x 3 days then 50mg a day thereafter | | OG001 | Control | Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only |
| |
| Secondary | Alexian Brothers Urge to Self-Injure Scale (ABUSI) | evidence-based metric of urge to self-harm. min = 0 max = 30. Higher scores represent more intense urges to self-injure | Numbers represent participants enrolled at this time point. | Posted | | Mean | Standard Deviation | score on a scale | | Measured at the following timepoints: enrollment | | | | ID | Title | Description |
|---|
| OG000 | Intervention | Oral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler Naltrexone Hydrochloride: 25mg x 3 days then 50mg a day thereafter | | OG001 | Control | Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only |
| |
| Secondary | Alexian Brothers Urge to Self-Injure Scale (ABUSI) | evidence-based metric of urge to self-harm. min = 0 max = 30. Higher scores represent more intense urges to self-injure | Numbers represent participants enrolled at this time point. | Posted | | Mean | Standard Deviation | score on a scale | | Measured at the following timepoints: one week | | | | ID | Title | Description |
|---|
| OG000 | Intervention | Oral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler Naltrexone Hydrochloride: 25mg x 3 days then 50mg a day thereafter | | OG001 | Control | Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only |
| |
| Secondary | Alexian Brothers Urge to Self-Injure Scale (ABUSI) | evidence-based metric of urge to self-harm. min = 0 max = 30. Higher scores represent more intense urges to self-injure | Numbers represent participants enrolled at this time point. | Posted | | Mean | Standard Deviation | score on a scale | | Measured at the following timepoints: three weeks | | | | ID | Title | Description |
|---|
| OG000 | Intervention | Oral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler Naltrexone Hydrochloride: 25mg x 3 days then 50mg a day thereafter | | OG001 | Control | Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only |
| |
| Secondary | Alexian Brothers Urge to Self-Injure Scale (ABUSI) | evidence-based metric of urge to self-harm. min = 0 max = 30. Higher scores represent more intense urges to self-injure | Numbers represent participants enrolled at this time point, other participants were lost to follow-up. | Posted | | Mean | Standard Deviation | score on a scale | | Measured at the following timepoints: six weeks | | | | ID | Title | Description |
|---|
| OG000 | Intervention | Oral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler Naltrexone Hydrochloride: 25mg x 3 days then 50mg a day thereafter | | OG001 | Control | Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only |
| |
| Secondary | Alexian Brothers Urge to Self-Injure Scale (ABUSI) | evidence-based metric of urge to self-harm. min = 0 max = 30. Higher scores represent more intense urges to self-injure | Numbers represent participants enrolled at this time point, other participants were lost to follow-up. | Posted | | Mean | Standard Deviation | score on a scale | | Measured at the following timepoints: nine weeks (last week of treatment) | | | | ID | Title | Description |
|---|
| OG000 | Intervention | Oral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler Naltrexone Hydrochloride: 25mg x 3 days then 50mg a day thereafter | | OG001 | Control | Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only |
| |
| Secondary | Alexian Brothers Urge to Self-Injure Scale (ABUSI) | evidence-based metric of urge to self-harm. min = 0 max = 30. Higher scores represent more intense urges to self-injure | Numbers represent participants enrolled at this time point, other participants were lost to follow-up. | Posted | | Mean | Standard Deviation | score on a scale | | Measured at the following timepoints: 6 months after enrollment | | | | ID | Title | Description |
|---|
| OG000 | Intervention | Oral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler Naltrexone Hydrochloride: 25mg x 3 days then 50mg a day thereafter | | OG001 | Control | Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only |
| |
| Secondary | Barratt Impulsiveness Scale (BIS-11) | Evidence-based metric of impulsivity. min = 30 max = 120. higher scores indicate higher levels of impulsivity. | Numbers represent participants enrolled at this time point. | Posted | | Mean | Standard Deviation | score on a scale | | Measured at the following timepoints: enrollment | | | | ID | Title | Description |
|---|
| OG000 | Intervention | Oral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler Naltrexone Hydrochloride: 25mg x 3 days then 50mg a day thereafter | | OG001 | Control | Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only |
| |
| Secondary | Barratt Impulsiveness Scale (BIS-11) | Evidence-based metric of impulsivity. min = 30 max = 120. higher scores indicate higher levels of impulsivity. | Numbers represent participants enrolled at this time point. | Posted | | Mean | Standard Deviation | score on a scale | | Measured at the following timepoints: one week | | | | ID | Title | Description |
|---|
| OG000 | Intervention | Oral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler Naltrexone Hydrochloride: 25mg x 3 days then 50mg a day thereafter | | OG001 | Control | Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only |
| |
| Secondary | Barratt Impulsiveness Scale (BIS-11) | Evidence-based metric of impulsivity. min = 30 max = 120. higher scores indicate higher levels of impulsivity. | Numbers represent participants enrolled at this time point. | Posted | | Mean | Standard Deviation | score on a scale | | Measured at the following timepoints: three weeks | | | | ID | Title | Description |
|---|
| OG000 | Intervention | Oral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler Naltrexone Hydrochloride: 25mg x 3 days then 50mg a day thereafter | | OG001 | Control | Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only |
| |
| Secondary | Barratt Impulsiveness Scale (BIS-11) | Evidence-based metric of impulsivity. min = 30 max = 120. higher scores indicate higher levels of impulsivity. | Numbers represent participants enrolled at this time point, other participants were lost to follow-up. | Posted | | Mean | Standard Deviation | score on a scale | | Measured at the following timepoints: six weeks | | | | ID | Title | Description |
|---|
| OG000 | Intervention | Oral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler Naltrexone Hydrochloride: 25mg x 3 days then 50mg a day thereafter | | OG001 | Control | Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only |
| |
| Secondary | Barratt Impulsiveness Scale (BIS-11) | Evidence-based metric of impulsivity. min = 30 max = 120. higher scores indicate higher levels of impulsivity. | Numbers represent participants enrolled at this time point, other participants were lost to follow-up. | Posted | | Mean | Standard Deviation | score on a scale | | Measured at the following timepoints: nine weeks (last week of treatment) | | | | ID | Title | Description |
|---|
| OG000 | Intervention | Oral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler Naltrexone Hydrochloride: 25mg x 3 days then 50mg a day thereafter | | OG001 | Control | Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only |
| |
| Secondary | Barratt Impulsiveness Scale (BIS-11) | Evidence-based metric of impulsivity. min = 30 max = 120. higher scores indicate higher levels of impulsivity. | Numbers represent participants enrolled at this time point, other participants were lost to follow-up. | Posted | | Mean | Standard Deviation | score on a scale | | Measured at the following timepoints: 6 months after enrollment | | | | ID | Title | Description |
|---|
| OG000 | Intervention | Oral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler Naltrexone Hydrochloride: 25mg x 3 days then 50mg a day thereafter | | OG001 | Control | Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only |
| |
| Secondary | Percent of Weight Restoration | For participants who need to restore weight, will evaluate the percent of weight gain in care | Numbers reflect participants enrolled at this time point. Other participants are lost to follow-up. | Posted | | Mean | Standard Deviation | percentage of weight restoration | | Will evaluate total percent of weight restoration via chart review at 9 weeks | | | | ID | Title | Description |
|---|
| OG000 | Intervention | Oral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler Naltrexone Hydrochloride: 25mg x 3 days then 50mg a day thereafter | | OG001 | Control | Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only |
| |
| Secondary | Percent of Weight Restoration | For participants who need to restore weight, will evaluate the percent of weight gain in care | Numbers represent participants enrolled at this time point, other participants were lost to follow-up. | Posted | | Mean | Standard Deviation | percentage of weight restoration | | Will evaluate total percent of weight restoration via chart review 6 months after enrollment at about 33 weeks | | | | ID | Title | Description |
|---|
| OG000 | Intervention | Oral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler Naltrexone Hydrochloride: 25mg x 3 days then 50mg a day thereafter | | OG001 | Control | Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only |
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| Secondary | Need For Higher Level of Care | Need to leave the current level of care (where the study is being conducted) to go to a residential, inpatient, or hospital facility | We collected data for 8 out of 9 participants because an in-person visit was required for this variable to be evaluated. One participant was lost to follow-up and did not have an in-person visit at this time period. | Posted | | Count of Participants | | Participants | | Will evaluate need for higher level of care at nine weeks | | | | ID | Title | Description |
|---|
| OG000 | Intervention | Oral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler Naltrexone Hydrochloride: 25mg x 3 days then 50mg a day thereafter | | OG001 | Control | Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only |
| |
| Secondary | Need For Higher Level of Care | Need to leave the current level of care (where the study is being conducted) to go to a residential, inpatient, or hospital facility | Numbers represent participants enrolled at this time point, other participants were lost to follow-up. | Posted | | Count of Participants | | Participants | | Will evaluate need for higher level of care at 6 months after the end of the study at about 33 weeks | | | | ID | Title | Description |
|---|
| OG000 | Intervention | Oral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler Naltrexone Hydrochloride: 25mg x 3 days then 50mg a day thereafter | | OG001 | Control | Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only |
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| Other Pre-specified | Columbia Suicide Severity Rating Scale (CSSRS) | Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores range from 1 (low risk) to 3 (high risk). | Numbers represent participants enrolled at this time point, other participants were lost to follow-up. | Posted | | Count of Participants | | Participants | | Measured at enrollment for patients age 17 or older | | | | ID | Title | Description |
|---|
| OG000 | Intervention | Oral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler Naltrexone Hydrochloride: 25mg x 3 days then 50mg a day thereafter | | OG001 | Control | Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only |
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| Other Pre-specified | Columbia Suicide Severity Rating Scale (CSSRS) | Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores range from 1 (low risk) to 3 (high risk). | Numbers represent participants enrolled at this time point, other participants were lost to follow-up. | Posted | | Count of Participants | | Participants | | week 1 for patients age 17 or older | | | | ID | Title | Description |
|---|
| OG000 | Intervention | Oral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler Naltrexone Hydrochloride: 25mg x 3 days then 50mg a day thereafter | | OG001 | Control | Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only |
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| Other Pre-specified | Columbia Suicide Severity Rating Scale (CSSRS) | Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores range from 1 (low risk) to 3 (high risk). | Numbers represent participants enrolled at this time point, other participants were lost to follow-up. | Posted | | Count of Participants | | Participants | | week 2 for patients age 17 or older | | | | ID | Title | Description |
|---|
| OG000 | Intervention | Oral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler Naltrexone Hydrochloride: 25mg x 3 days then 50mg a day thereafter | | OG001 | Control | Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only |
| |
| Other Pre-specified | Columbia Suicide Severity Rating Scale (CSSRS) | Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores range from 1 (low risk) to 3 (high risk). | Numbers represent participants enrolled at this time point, other participants were lost to follow-up. | Posted | | Count of Participants | | Participants | | week 3 for patients age 17 or older | | | | ID | Title | Description |
|---|
| OG000 | Intervention | Oral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler Naltrexone Hydrochloride: 25mg x 3 days then 50mg a day thereafter | | OG001 | Control | Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only |
| |
| Other Pre-specified | Columbia Suicide Severity Rating Scale (CSSRS) | Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores range from 1 (low risk) to 3 (high risk). | Numbers represent participants enrolled at this time point, other participants were lost to follow-up. | Posted | | Count of Participants | | Participants | | week 4 for patients age 17 or older | | | | ID | Title | Description |
|---|
| OG000 | Intervention | Oral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler Naltrexone Hydrochloride: 25mg x 3 days then 50mg a day thereafter | | OG001 | Control | Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only |
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| Other Pre-specified | Columbia Suicide Severity Rating Scale (CSSRS) | Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores range from 1 (low risk) to 3 (high risk). | Numbers represent participants enrolled at this time point, other participants were lost to follow-up. | Posted | | Count of Participants | | Participants | | week 5 for patients age 17 or older | | | | ID | Title | Description |
|---|
| OG000 | Intervention | Oral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler Naltrexone Hydrochloride: 25mg x 3 days then 50mg a day thereafter | | OG001 | Control | Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only |
| |
| Other Pre-specified | Columbia Suicide Severity Rating Scale (CSSRS) | Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores range from 1 (low risk) to 3 (high risk). | Numbers represent participants enrolled at this time point, other participants were lost to follow-up. | Posted | | Count of Participants | | Participants | | week 6 for patients age 17 or older | | | | ID | Title | Description |
|---|
| OG000 | Intervention | Oral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler Naltrexone Hydrochloride: 25mg x 3 days then 50mg a day thereafter | | OG001 | Control | Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only |
| |
| Other Pre-specified | Columbia Suicide Severity Rating Scale (CSSRS) | Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores range from 1 (low risk) to 3 (high risk). | Numbers represent participants enrolled at this time point, other participants were lost to follow-up. | Posted | | | | | | week 7 for patients age 17 or older | | | | ID | Title | Description |
|---|
| OG000 | Intervention | Oral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler Naltrexone Hydrochloride: 25mg x 3 days then 50mg a day thereafter | | OG001 | Control | Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only |
| |
| Other Pre-specified | Columbia Suicide Severity Rating Scale (CSSRS) | Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores range from 1 (low risk) to 3 (high risk). | Numbers represent participants enrolled at this time point, other participants were lost to follow-up. | Posted | | | | | | week 8 for patients age 17 or older | | | | ID | Title | Description |
|---|
| OG000 | Intervention | Oral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler Naltrexone Hydrochloride: 25mg x 3 days then 50mg a day thereafter | | OG001 | Control | Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only |
| |
| Other Pre-specified | Columbia Suicide Severity Rating Scale (CSSRS) | Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores range from 1 (low risk) to 3 (high risk). | Numbers represent participants enrolled at this time point, other participants were lost to follow-up. | Posted | | | | | | week 9 for patients age 17 or older | | | | ID | Title | Description |
|---|
| OG000 | Intervention | Oral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler Naltrexone Hydrochloride: 25mg x 3 days then 50mg a day thereafter | | OG001 | Control | Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only |
| |
| Other Pre-specified | Columbia Suicide Severity Rating Scale (CSSRS) | Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores range from 1 (low risk) to 3 (high risk). | Numbers represent participants enrolled at this time point, other participants were lost to follow-up. | Posted | | | | | | 6 months after enrollment for patients age 17 or older | | | | ID | Title | Description |
|---|
| OG000 | Intervention | Oral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler Naltrexone Hydrochloride: 25mg x 3 days then 50mg a day thereafter | | OG001 | Control | Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only |
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| Other Pre-specified | Ask Suicide Screening Questions (ASQ) | Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores include 1 (negative screen), 2 (non-acute positive screen), and 3 (acute positive screen). Higher scores represent higher suicidal ideation and higher risk of suicide. | Numbers represent participants enrolled at this time point. | Posted | | Count of Participants | | Participants | | Measured at enrollment for patients age 16 or younger | | | | ID | Title | Description |
|---|
| OG000 | Intervention | Oral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler Naltrexone Hydrochloride: 25mg x 3 days then 50mg a day thereafter | | OG001 | Control | Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only |
| |
| Other Pre-specified | Ask Suicide Screening Questions (ASQ) | Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores include 1 (negative screen), 2 (non-acute positive screen), and 3 (acute positive screen). Higher scores represent higher suicidal ideation and higher risk of suicide. | Numbers represent participants enrolled at this time point, other participants were lost to follow-up. | Posted | | Count of Participants | | Participants | | week 1 for patients age 16 or younger | | | | ID | Title | Description |
|---|
| OG000 | Intervention | Oral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler Naltrexone Hydrochloride: 25mg x 3 days then 50mg a day thereafter | | OG001 | Control | Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only |
| |
| Other Pre-specified | Ask Suicide Screening Questions (ASQ) | Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores include 1 (negative screen), 2 (non-acute positive screen), and 3 (acute positive screen). Higher scores represent higher suicidal ideation and higher risk of suicide. | Numbers represent participants enrolled at this time point. | Posted | | Count of Participants | | Participants | | week 2 for patients age 16 or younger | | | | ID | Title | Description |
|---|
| OG000 | Intervention | Oral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler Naltrexone Hydrochloride: 25mg x 3 days then 50mg a day thereafter | | OG001 | Control | Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only |
| |
| Other Pre-specified | Ask Suicide Screening Questions (ASQ) | Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores include 1 (negative screen), 2 (non-acute positive screen), and 3 (acute positive screen). Higher scores represent higher suicidal ideation and higher risk of suicide. | Numbers represent participants enrolled at this time point. | Posted | | Count of Participants | | Participants | | week 3 for patients age 16 or younger | | | | ID | Title | Description |
|---|
| OG000 | Intervention | Oral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler Naltrexone Hydrochloride: 25mg x 3 days then 50mg a day thereafter | | OG001 | Control | Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only |
| |
| Other Pre-specified | Ask Suicide Screening Questions (ASQ) | Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores include 1 (negative screen), 2 (non-acute positive screen), and 3 (acute positive screen). Higher scores represent higher suicidal ideation and higher risk of suicide. | Numbers represent participants enrolled at this time point, other participants were lost to follow-up. | Posted | | Count of Participants | | Participants | | week 4 for patients age 16 or younger | | | | ID | Title | Description |
|---|
| OG000 | Intervention | Oral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler Naltrexone Hydrochloride: 25mg x 3 days then 50mg a day thereafter | | OG001 | Control | Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only |
| |
| Other Pre-specified | Ask Suicide Screening Questions (ASQ) | Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores include 1 (negative screen), 2 (non-acute positive screen), and 3 (acute positive screen). Higher scores represent higher suicidal ideation and higher risk of suicide. | Numbers represent participants enrolled at this time point, other participants were lost to follow-up. | Posted | | Count of Participants | | Participants | | week 5 for patients age 16 or younger | | | | ID | Title | Description |
|---|
| OG000 | Intervention | Oral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler Naltrexone Hydrochloride: 25mg x 3 days then 50mg a day thereafter | | OG001 | Control | Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only |
| |
| Other Pre-specified | Ask Suicide Screening Questions (ASQ) | Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores include 1 (negative screen), 2 (non-acute positive screen), and 3 (acute positive screen). Higher scores represent higher suicidal ideation and higher risk of suicide. | Numbers represent participants enrolled at this time point, other participants were lost to follow-up. | Posted | | Count of Participants | | Participants | | week 6 for patients age 16 or younger | | | | ID | Title | Description |
|---|
| OG000 | Intervention | Oral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler Naltrexone Hydrochloride: 25mg x 3 days then 50mg a day thereafter | | OG001 | Control | Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only |
| |
| Other Pre-specified | Ask Suicide Screening Questions (ASQ) | Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores include 1 (negative screen), 2 (non-acute positive screen), and 3 (acute positive screen). Higher scores represent higher suicidal ideation and higher risk of suicide. | Numbers represent participants enrolled at this time point, other participants were lost to follow-up. | Posted | | | | | | week 7 for patients age 16 or younger | | | | ID | Title | Description |
|---|
| OG000 | Intervention | Oral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler Naltrexone Hydrochloride: 25mg x 3 days then 50mg a day thereafter | | OG001 | Control | Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only |
| |
| Other Pre-specified | Ask Suicide Screening Questions (ASQ) | Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores include 1 (negative screen), 2 (non-acute positive screen), and 3 (acute positive screen). Higher scores represent higher suicidal ideation and higher risk of suicide. | Numbers represent participants enrolled at this time point, other participants were lost to follow-up. | Posted | | Count of Participants | | Participants | | week 8 for patients age 16 or younger | | | | ID | Title | Description |
|---|
| OG000 | Intervention | Oral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler Naltrexone Hydrochloride: 25mg x 3 days then 50mg a day thereafter | | OG001 | Control | Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only |
| |
| Other Pre-specified | Ask Suicide Screening Questions (ASQ) | Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores include 1 (negative screen), 2 (non-acute positive screen), and 3 (acute positive screen). Higher scores represent higher suicidal ideation and higher risk of suicide. | Numbers represent participants enrolled at this time point, other participants were lost to follow-up. | Posted | | Count of Participants | | Participants | | week 9 for patients age 16 or younger | | | | ID | Title | Description |
|---|
| OG000 | Intervention | Oral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler Naltrexone Hydrochloride: 25mg x 3 days then 50mg a day thereafter | | OG001 | Control | Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only |
| |
| Other Pre-specified | Ask Suicide Screening Questions (ASQ) | Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores include 1 (negative screen), 2 (non-acute positive screen), and 3 (acute positive screen). Higher scores represent higher suicidal ideation and higher risk of suicide. | Numbers represent participants enrolled at this time point, other participants were lost to follow-up. | Posted | | Count of Participants | | Participants | | 6 months after enrollment for patients age 16 or younger | | | | ID | Title | Description |
|---|
| OG000 | Intervention | Oral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler Naltrexone Hydrochloride: 25mg x 3 days then 50mg a day thereafter | | OG001 | Control | Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only |
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