Trial Outcomes & Findings for Oral Naltrexone In Pediatric Eating Disorders (NCT NCT05073679)

NCT ID: NCT05073679

Last Updated: 2025-08-19

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: PHASE2/PHASE3
• Target enrollment: 9 participants
• Primary outcome timeframe: Time Frame: Measured at the following timepoints: enrollment
• Results posted on: 2025-08-19

Participant Flow

Participant milestones

Measure	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	Control Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only
Overall Study STARTED	5	4
Overall Study COMPLETED	5	4
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Oral Naltrexone In Pediatric Eating Disorders

Baseline characteristics by cohort

Measure	Intervention n=5 Participants 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	Control n=4 Participants Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only	Total n=9 Participants Total of all reporting groups
Age, Continuous	16 years n=93 Participants	17 years n=4 Participants	16.5 years n=27 Participants
Sex: Female, Male Female	5 Participants n=93 Participants	4 Participants n=4 Participants	9 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) White	4 Participants n=93 Participants	1 Participants n=4 Participants	5 Participants n=27 Participants
Race (NIH/OMB) More than one race	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants
Race/Ethnicity, Customized Non-Hispanic	5 Participants n=93 Participants	1 Participants n=4 Participants	6 Participants n=27 Participants
Race/Ethnicity, Customized Hispanic	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race/Ethnicity, Customized Multiple	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race/Ethnicity, Customized Unknown	0 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants
Region of Enrollment United States	5 Participants n=93 Participants	4 Participants n=4 Participants	9 Participants n=27 Participants

PRIMARY outcome

Timeframe: Time Frame: Measured at the following timepoints: enrollment

Population: Numbers represent participants enrolled at this time point.

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.

Outcome measures

Measure	Intervention n=5 Participants 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	Control n=4 Participants Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only
ED-15 Score	3.5 score on a scale Standard Deviation 2.016184515	4.7 score on a scale Standard Deviation 0.871779789

PRIMARY outcome

Timeframe: Time Frame: Measured at the following timepoints: one week

Population: Numbers represent participants enrolled at this time point.

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.

Outcome measures

Measure	Intervention n=5 Participants 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	Control n=4 Participants Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only
ED-15 Score	3.08 score on a scale Standard Deviation 1.845806057	4.675 score on a scale Standard Deviation 0.784750491

PRIMARY outcome

Timeframe: Time Frame: Measured at the following timepoints: three week

Population: Numbers represent participants enrolled at this time point.

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.

Outcome measures

Measure	Intervention n=5 Participants 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	Control n=4 Participants Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only
ED-15 Score	3.04 score on a scale Standard Deviation 1.820164828	4.025 score on a scale Standard Deviation 1.508586535

PRIMARY outcome

Timeframe: Time Frame: Measured at the following timepoints: six weeks

Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.

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.

Outcome measures

Measure	Intervention n=4 Participants 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	Control n=3 Participants Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only
ED-15 Score	1.825 score on a scale Standard Deviation 1.701714821	3.5 score on a scale Standard Deviation 2.364318084

PRIMARY outcome

Timeframe: Time Frame: Measured at the following timepoints: nine weeks (last week of treatment)

Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.

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.

Outcome measures

Measure	Intervention n=4 Participants 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	Control n=1 Participants Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only
ED-15 Score	1.075 score on a scale Standard Deviation 0.736545993	4.5 score on a scale Standard Deviation 0

PRIMARY outcome

Timeframe: Time Frame: Measured at the following timepoints: 6 months after enrollment

Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.

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.

Outcome measures

Measure	Intervention n=3 Participants 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	Control n=1 Participants Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only
ED-15 Score	0.866666667 score on a scale Standard Deviation 0.776745347	4.3 score on a scale Standard Deviation 0

SECONDARY outcome

Timeframe: Measured at the following timepoints: enrollment

Population: Numbers represent participants enrolled at this time point.

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.

Outcome measures

Measure	Intervention n=5 Participants 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	Control n=4 Participants Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only
Eating Disorder Examination Questionnaire Score (EDE-Q)	3.3925 score on a scale Standard Deviation 1.8216	4.72031 score on a scale Standard Deviation 0.806764613

SECONDARY outcome

Timeframe: Measured at the following timepoints: one week

Population: Numbers represent participants enrolled at this time point.

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.

Outcome measures

Measure	Intervention n=5 Participants 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	Control n=4 Participants Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only
Eating Disorder Examination Questionnaire Score (EDE-Q)	2.87 score on a scale Standard Deviation 1.744810385	4.315625 score on a scale Standard Deviation 0.645285386

SECONDARY outcome

Timeframe: Measured at the following timepoints: three weeks

Population: Numbers represent participants enrolled at this time point.

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.

Outcome measures

Measure	Intervention n=5 Participants 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	Control n=4 Participants Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only
Eating Disorder Examination Questionnaire Score (EDE-Q)	2.66375 score on a scale Standard Deviation 1.553369573	3.9953125 score on a scale Standard Deviation 1.634008483

SECONDARY outcome

Timeframe: Measured at the following timepoints: six weeks

Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.

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.

Outcome measures

Measure	Intervention n=4 Participants 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	Control n=3 Participants Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only
Eating Disorder Examination Questionnaire Score (EDE-Q)	1.6546875 score on a scale Standard Deviation 1.524132053	3.2 score on a scale Standard Deviation 2.385773263

SECONDARY outcome

Timeframe: Measured at the following timepoints: nine weeks (last week of treatment)

Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.

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.

Outcome measures

Measure	Intervention n=4 Participants 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	Control n=1 Participants Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only
Eating Disorder Examination Questionnaire Score (EDE-Q)	0.753125 score on a scale Standard Deviation 0.538770301	4.04375 score on a scale Standard Deviation 0

SECONDARY outcome

Timeframe: Measured at the following timepoints: 6 months after enrollment

Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.

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.

Outcome measures

Measure	Intervention n=3 Participants 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	Control n=1 Participants Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only
Eating Disorder Examination Questionnaire Score (EDE-Q)	2.4125 score on a scale Standard Deviation 0.724577822	3.90625 score on a scale Standard Deviation 0

SECONDARY outcome

Timeframe: Measured at the following timepoints: enrollment

Population: Numbers represent participants enrolled at this time point.

Evidence-based metric of depression, min = 0, max= 27, higher scores indicate more severe depression

Outcome measures

Measure	Intervention n=5 Participants 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	Control n=4 Participants Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only
Patient Health Questionnaire Score (PHQ-9)	13.8 score on a scale Standard Deviation 8.043631021	12 score on a scale Standard Deviation 4.966554809

SECONDARY outcome

Timeframe: Measured at the following timepoints: one week

Population: Numbers represent participants enrolled at this time point.

Evidence-based metric of depression, min = 0, max= 27, higher scores indicate more severe depression

Outcome measures

Measure	Intervention n=5 Participants 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	Control n=4 Participants Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only
Patient Health Questionnaire Score (PHQ-9)	12.8 score on a scale Standard Deviation 8.167006796	11.5 score on a scale Standard Deviation 4.203173404

SECONDARY outcome

Timeframe: Measured at the following timepoints: three weeks

Population: Numbers represent participants enrolled at this time point.

Evidence-based metric of depression, min = 0, max= 27, higher scores indicate more severe depression

Outcome measures

Measure	Intervention n=5 Participants 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	Control n=4 Participants Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only
Patient Health Questionnaire Score (PHQ-9)	10.4 score on a scale Standard Deviation 6.268971207	10.75 score on a scale Standard Deviation 4.991659711

SECONDARY outcome

Timeframe: Measured at the following timepoints: six weeks

Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.

Evidence-based metric of depression, min = 0, max= 27, higher scores indicate more severe depression

Outcome measures

Measure	Intervention n=4 Participants 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	Control n=3 Participants Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only
Patient Health Questionnaire Score (PHQ-9)	7.5 score on a scale Standard Deviation 4.434711565	10.66666667 score on a scale Standard Deviation 2.309401077

SECONDARY outcome

Timeframe: Measured at the following timepoints: nine weeks (last week of treatment)

Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.

Evidence-based metric of depression, min = 0, max= 27, higher scores indicate more severe depression

Outcome measures

Measure	Intervention n=4 Participants 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	Control n=2 Participants Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only
Patient Health Questionnaire Score (PHQ-9)	5.5 score on a scale Standard Deviation 6.191391874	12.5 score on a scale Standard Deviation 9.192388155

SECONDARY outcome

Timeframe: Measured at the following timepoints: 6 months after enrollment

Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.

Evidence-based metric of depression, min = 0, max= 27, higher scores indicate more severe depression

Outcome measures

Measure	Intervention n=3 Participants 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	Control n=1 Participants Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only
Patient Health Questionnaire Score (PHQ-9)	4.666666667 score on a scale Standard Deviation 5.507570547	4 score on a scale Standard Deviation 0

SECONDARY outcome

Timeframe: Measured at the following timepoints: enrollment

Population: Numbers represent participants enrolled at this time point.

evidence-based metric of anxiety, min=0, max=21, higher scores indicate more severe anxiety

Outcome measures

Measure	Intervention n=5 Participants 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	Control n=4 Participants Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only
Generalized Anxiety Disorder Screener Score (GAD-7)	10.8 score on a scale Standard Deviation 3.271085447	13.75 score on a scale Standard Deviation 5.560275773

SECONDARY outcome

Timeframe: Measured at the following timepoints: one week

Population: Numbers represent participants enrolled at this time point.

evidence-based metric of anxiety, min=0, max=21, higher scores indicate more severe anxiety

Outcome measures

Measure	Intervention n=5 Participants 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	Control n=4 Participants Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only
Generalized Anxiety Disorder Screener Score (GAD-7)	7.4 score on a scale Standard Deviation 3.577708764	12.75 score on a scale Standard Deviation 4.716990566

SECONDARY outcome

Timeframe: Measured at the following timepoints: three weeks

Population: Numbers represent participants enrolled at this time point.

evidence-based metric of anxiety, min=0, max=21, higher scores indicate more severe anxiety

Outcome measures

Measure	Intervention n=5 Participants 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	Control n=4 Participants Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only
Generalized Anxiety Disorder Screener Score (GAD-7)	6.8 score on a scale Standard Deviation 4.438468204	11 score on a scale Standard Deviation 4.69041576

SECONDARY outcome

Timeframe: Measured at the following timepoints: six weeks

Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.

evidence-based metric of anxiety, min=0, max=21, higher scores indicate more severe anxiety

Outcome measures

Measure	Intervention n=4 Participants 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	Control n=3 Participants Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only
Generalized Anxiety Disorder Screener Score (GAD-7)	6.75 score on a scale Standard Deviation 4.645786622	10.33333333 score on a scale Standard Deviation 3.511884584

SECONDARY outcome

Timeframe: Measured at the following timepoints: nine weeks (last week of treatment)

Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.

evidence-based metric of anxiety, min=0, max=21, higher scores indicate more severe anxiety

Outcome measures

Measure	Intervention n=4 Participants 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	Control n=2 Participants Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only
Generalized Anxiety Disorder Screener Score (GAD-7)	6 score on a scale Standard Deviation 6.976149845	9 score on a scale Standard Deviation 5.656854249

SECONDARY outcome

Timeframe: Measured at the following timepoints: 6 months after enrollment

Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.

evidence-based metric of anxiety, min=0, max=21, higher scores indicate more severe anxiety

Outcome measures

Measure	Intervention n=3 Participants 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	Control n=1 Participants Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only
Generalized Anxiety Disorder Screener Score (GAD-7)	5.666666667 score on a scale Standard Deviation 1.154700538	6 score on a scale Standard Deviation 0

SECONDARY outcome

Timeframe: Measured at the following timepoints: enrollment

Population: Numbers represent participants enrolled at this time point.

evidence-based metric of urge to self-harm. min = 0 max = 30. Higher scores represent more intense urges to self-injure

Outcome measures

Measure	Intervention n=5 Participants 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	Control n=4 Participants Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only
Alexian Brothers Urge to Self-Injure Scale (ABUSI)	3.4 score on a scale Standard Deviation 3.435112807	7.25 score on a scale Standard Deviation 7.632168761

SECONDARY outcome

Timeframe: Measured at the following timepoints: one week

Population: Numbers represent participants enrolled at this time point.

evidence-based metric of urge to self-harm. min = 0 max = 30. Higher scores represent more intense urges to self-injure

Outcome measures

Measure	Intervention n=5 Participants 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	Control n=4 Participants Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only
Alexian Brothers Urge to Self-Injure Scale (ABUSI)	3.6 score on a scale Standard Deviation 4.098780306	5.75 score on a scale Standard Deviation 4.924428901

SECONDARY outcome

Timeframe: Measured at the following timepoints: three weeks

Population: Numbers represent participants enrolled at this time point.

evidence-based metric of urge to self-harm. min = 0 max = 30. Higher scores represent more intense urges to self-injure

Outcome measures

Measure	Intervention n=5 Participants 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	Control n=4 Participants Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only
Alexian Brothers Urge to Self-Injure Scale (ABUSI)	2.8 score on a scale Standard Deviation 2.387467277	4.5 score on a scale Standard Deviation 3.415650255

SECONDARY outcome

Timeframe: Measured at the following timepoints: six weeks

Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.

evidence-based metric of urge to self-harm. min = 0 max = 30. Higher scores represent more intense urges to self-injure

Outcome measures

Measure	Intervention n=4 Participants 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	Control n=3 Participants Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only
Alexian Brothers Urge to Self-Injure Scale (ABUSI)	2.25 score on a scale Standard Deviation 2.62995564	11 score on a scale Standard Deviation 6.08276253

SECONDARY outcome

Timeframe: Measured at the following timepoints: nine weeks (last week of treatment)

Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.

evidence-based metric of urge to self-harm. min = 0 max = 30. Higher scores represent more intense urges to self-injure

Outcome measures

Measure	Intervention n=4 Participants 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	Control n=2 Participants Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only
Alexian Brothers Urge to Self-Injure Scale (ABUSI)	1.5 score on a scale Standard Deviation 3	9 score on a scale Standard Deviation 12.72792206

SECONDARY outcome

Timeframe: Measured at the following timepoints: 6 months after enrollment

Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.

evidence-based metric of urge to self-harm. min = 0 max = 30. Higher scores represent more intense urges to self-injure

Outcome measures

Measure	Intervention n=3 Participants 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	Control n=1 Participants Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only
Alexian Brothers Urge to Self-Injure Scale (ABUSI)	0.333333333 score on a scale Standard Deviation 0.577350269	0 score on a scale Standard Deviation 0

SECONDARY outcome

Timeframe: Measured at the following timepoints: enrollment

Population: Numbers represent participants enrolled at this time point.

Evidence-based metric of impulsivity. min = 30 max = 120. higher scores indicate higher levels of impulsivity.

Outcome measures

Measure	Intervention n=5 Participants 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	Control n=4 Participants Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only
Barratt Impulsiveness Scale (BIS-11)	62.2 score on a scale Standard Deviation 14.44645285	72.25 score on a scale Standard Deviation 9.569918147

SECONDARY outcome

Timeframe: Measured at the following timepoints: one week

Population: Numbers represent participants enrolled at this time point.

Evidence-based metric of impulsivity. min = 30 max = 120. higher scores indicate higher levels of impulsivity.

Outcome measures

Measure	Intervention n=5 Participants 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	Control n=4 Participants Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only
Barratt Impulsiveness Scale (BIS-11)	64 score on a scale Standard Deviation 17.88854382	71 score on a scale Standard Deviation 6.976149845

SECONDARY outcome

Timeframe: Measured at the following timepoints: three weeks

Population: Numbers represent participants enrolled at this time point.

Evidence-based metric of impulsivity. min = 30 max = 120. higher scores indicate higher levels of impulsivity.

Outcome measures

Measure	Intervention n=5 Participants 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	Control n=4 Participants Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only
Barratt Impulsiveness Scale (BIS-11)	64.4 score on a scale Standard Deviation 12.77888884	69.5 score on a scale Standard Deviation 5.744562647

SECONDARY outcome

Timeframe: Measured at the following timepoints: six weeks

Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.

Evidence-based metric of impulsivity. min = 30 max = 120. higher scores indicate higher levels of impulsivity.

Outcome measures

Measure	Intervention n=4 Participants 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	Control n=3 Participants Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only
Barratt Impulsiveness Scale (BIS-11)	65.25 score on a scale Standard Deviation 14.22146265	69.66666667 score on a scale Standard Deviation 6.506407099

SECONDARY outcome

Timeframe: Measured at the following timepoints: nine weeks (last week of treatment)

Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.

Evidence-based metric of impulsivity. min = 30 max = 120. higher scores indicate higher levels of impulsivity.

Outcome measures

Measure	Intervention n=4 Participants 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	Control n=2 Participants Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only
Barratt Impulsiveness Scale (BIS-11)	63.25 score on a scale Standard Deviation 14.97497913	71 score on a scale Standard Deviation 12.72792206

SECONDARY outcome

Timeframe: Measured at the following timepoints: 6 months after enrollment

Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.

Evidence-based metric of impulsivity. min = 30 max = 120. higher scores indicate higher levels of impulsivity.

Outcome measures

Measure	Intervention n=3 Participants 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	Control n=1 Participants Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only
Barratt Impulsiveness Scale (BIS-11)	64 score on a scale Standard Deviation 10.58300524	60 score on a scale Standard Deviation 0

SECONDARY outcome

Timeframe: Will evaluate total percent of weight restoration via chart review at 9 weeks

Population: Numbers reflect participants enrolled at this time point. Other participants are lost to follow-up.

For participants who need to restore weight, will evaluate the percent of weight gain in care

Outcome measures

Measure	Intervention n=4 Participants 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	Control n=2 Participants Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only
Percent of Weight Restoration	100.25 percentage of weight restoration Standard Deviation 5.068	94 percentage of weight restoration Standard Deviation 12

SECONDARY outcome

Timeframe: Will evaluate total percent of weight restoration via chart review 6 months after enrollment at about 33 weeks

Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.

For participants who need to restore weight, will evaluate the percent of weight gain in care

Outcome measures

Measure	Intervention n=2 Participants 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	Control n=2 Participants Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only
Percent of Weight Restoration	100.5 percentage of weight restoration Standard Deviation 10.60660172	84.5 percentage of weight restoration Standard Deviation 7.778174593

SECONDARY outcome

Timeframe: Will evaluate need for higher level of care at nine weeks

Population: 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.

Need to leave the current level of care (where the study is being conducted) to go to a residential, inpatient, or hospital facility

Outcome measures

Measure	Intervention n=4 Participants 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	Control n=4 Participants Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only
Need For Higher Level of Care Need for Higher Level of Care	0 Participants	0 Participants
Need For Higher Level of Care No Need for Higher Level of Care	4 Participants	4 Participants

SECONDARY outcome

Timeframe: Will evaluate need for higher level of care at 6 months after the end of the study at about 33 weeks

Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.

Need to leave the current level of care (where the study is being conducted) to go to a residential, inpatient, or hospital facility

Outcome measures

Measure	Intervention n=2 Participants 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	Control n=1 Participants Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only
Need For Higher Level of Care Need for Higher Level of Care	0 Participants	1 Participants
Need For Higher Level of Care No Need for Higher Level of Care	2 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Measured at enrollment for patients age 17 or older

Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.

Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores range from 1 (low risk) to 3 (high risk).

Outcome measures

Measure	Intervention n=1 Participants 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	Control n=2 Participants Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only
Columbia Suicide Severity Rating Scale (CSSRS) Low Risk	0 Participants	1 Participants
Columbia Suicide Severity Rating Scale (CSSRS) Medium Risk	1 Participants	1 Participants
Columbia Suicide Severity Rating Scale (CSSRS) High Risk	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: week 1 for patients age 17 or older

Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.

Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores range from 1 (low risk) to 3 (high risk).

Outcome measures

Measure	Intervention n=1 Participants 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	Control n=2 Participants Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only
Columbia Suicide Severity Rating Scale (CSSRS) Low Risk	1 Participants	1 Participants
Columbia Suicide Severity Rating Scale (CSSRS) Medium Risk	0 Participants	1 Participants
Columbia Suicide Severity Rating Scale (CSSRS) High Risk	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: week 2 for patients age 17 or older

Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.

Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores range from 1 (low risk) to 3 (high risk).

Outcome measures

Measure	Intervention n=1 Participants 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	Control n=2 Participants Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only
Columbia Suicide Severity Rating Scale (CSSRS) Low Risk	0 Participants	1 Participants
Columbia Suicide Severity Rating Scale (CSSRS) Medium Risk	1 Participants	1 Participants
Columbia Suicide Severity Rating Scale (CSSRS) High Risk	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: week 3 for patients age 17 or older

Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.

Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores range from 1 (low risk) to 3 (high risk).

Outcome measures

Measure	Intervention n=1 Participants 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	Control n=2 Participants Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only
Columbia Suicide Severity Rating Scale (CSSRS) Low Risk	1 Participants	2 Participants
Columbia Suicide Severity Rating Scale (CSSRS) Medium Risk	0 Participants	0 Participants
Columbia Suicide Severity Rating Scale (CSSRS) High Risk	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: week 4 for patients age 17 or older

Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.

Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores range from 1 (low risk) to 3 (high risk).

Outcome measures

Measure	Intervention n=1 Participants 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	Control n=1 Participants Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only
Columbia Suicide Severity Rating Scale (CSSRS) Low Risk	0 Participants	1 Participants
Columbia Suicide Severity Rating Scale (CSSRS) Medium Risk	1 Participants	0 Participants
Columbia Suicide Severity Rating Scale (CSSRS) High Risk	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: week 5 for patients age 17 or older

Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.

Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores range from 1 (low risk) to 3 (high risk).

Outcome measures

Measure	Intervention n=1 Participants 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	Control n=1 Participants Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only
Columbia Suicide Severity Rating Scale (CSSRS) Low Risk	0 Participants	1 Participants
Columbia Suicide Severity Rating Scale (CSSRS) Medium Risk	1 Participants	0 Participants
Columbia Suicide Severity Rating Scale (CSSRS) High Risk	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: week 6 for patients age 17 or older

Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.

Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores range from 1 (low risk) to 3 (high risk).

Outcome measures

Measure	Intervention n=1 Participants 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	Control Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only
Columbia Suicide Severity Rating Scale (CSSRS) Low Risk	0 Participants	0 Participants
Columbia Suicide Severity Rating Scale (CSSRS) Medium Risk	1 Participants	0 Participants
Columbia Suicide Severity Rating Scale (CSSRS) High Risk	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: week 7 for patients age 17 or older

Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.

Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores range from 1 (low risk) to 3 (high risk).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: week 8 for patients age 17 or older

Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.

Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores range from 1 (low risk) to 3 (high risk).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: week 9 for patients age 17 or older

Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.

Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores range from 1 (low risk) to 3 (high risk).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months after enrollment for patients age 17 or older

Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.

Evidence-based metric evaluating for presence of suicidal ideation and severity. Scores range from 1 (low risk) to 3 (high risk).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Measured at enrollment for patients age 16 or younger

Population: Numbers represent participants enrolled at this time point.

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.

Outcome measures

Measure	Intervention n=4 Participants 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	Control n=2 Participants Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only
Ask Suicide Screening Questions (ASQ) Negative Screen	1 Participants	2 Participants
Ask Suicide Screening Questions (ASQ) Non-Acute Positive Screen	3 Participants	0 Participants
Ask Suicide Screening Questions (ASQ) Acute Positive Screen	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: week 1 for patients age 16 or younger

Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.

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.

Outcome measures

Measure	Intervention n=4 Participants 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	Control n=2 Participants Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only
Ask Suicide Screening Questions (ASQ) Negative Screen	1 Participants	1 Participants
Ask Suicide Screening Questions (ASQ) Non-Acute Positive Screen	3 Participants	1 Participants
Ask Suicide Screening Questions (ASQ) Acute Positive Screen	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: week 2 for patients age 16 or younger

Population: Numbers represent participants enrolled at this time point.

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.

Outcome measures

Measure	Intervention n=4 Participants 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	Control n=2 Participants Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only
Ask Suicide Screening Questions (ASQ) Negative Screen	1 Participants	1 Participants
Ask Suicide Screening Questions (ASQ) Non-Acute Positive Screen	3 Participants	1 Participants
Ask Suicide Screening Questions (ASQ) Acute Positive Screen	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: week 3 for patients age 16 or younger

Population: Numbers represent participants enrolled at this time point.

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.

Outcome measures

Measure	Intervention n=4 Participants 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	Control n=2 Participants Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only
Ask Suicide Screening Questions (ASQ) Negative Screen	1 Participants	1 Participants
Ask Suicide Screening Questions (ASQ) Non-Acute Positive Screen	3 Participants	1 Participants
Ask Suicide Screening Questions (ASQ) Acute Positive Screen	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: week 4 for patients age 16 or younger

Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.

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.

Outcome measures

Measure	Intervention n=2 Participants 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	Control n=2 Participants Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only
Ask Suicide Screening Questions (ASQ) Negative Screen	2 Participants	2 Participants
Ask Suicide Screening Questions (ASQ) Non-Acute Positive Screen	0 Participants	0 Participants
Ask Suicide Screening Questions (ASQ) Acute Positive Screen	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: week 5 for patients age 16 or younger

Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.

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.

Outcome measures

Measure	Intervention n=2 Participants 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	Control n=2 Participants Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only
Ask Suicide Screening Questions (ASQ) Negative Screen	1 Participants	2 Participants
Ask Suicide Screening Questions (ASQ) Non-Acute Positive Screen	1 Participants	0 Participants
Ask Suicide Screening Questions (ASQ) Acute Positive Screen	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: week 6 for patients age 16 or younger

Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.

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.

Outcome measures

Measure	Intervention n=3 Participants 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	Control n=2 Participants Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only
Ask Suicide Screening Questions (ASQ) Negative Screen	2 Participants	2 Participants
Ask Suicide Screening Questions (ASQ) Non-Acute Positive Screen	1 Participants	0 Participants
Ask Suicide Screening Questions (ASQ) Acute Positive Screen	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: week 7 for patients age 16 or younger

Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.

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.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: week 8 for patients age 16 or younger

Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.

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.

Outcome measures

Measure	Intervention n=3 Participants 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	Control n=1 Participants Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only
Ask Suicide Screening Questions (ASQ) Low Risk	2 Participants	1 Participants
Ask Suicide Screening Questions (ASQ) Medium Risk	1 Participants	0 Participants
Ask Suicide Screening Questions (ASQ) High Risk	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: week 9 for patients age 16 or younger

Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.

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.

Outcome measures

Measure	Intervention n=3 Participants 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	Control n=1 Participants Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only
Ask Suicide Screening Questions (ASQ) Negative Screen	2 Participants	1 Participants
Ask Suicide Screening Questions (ASQ) Non-Acute Positive Screen	1 Participants	0 Participants
Ask Suicide Screening Questions (ASQ) Acute Positive Screen	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 months after enrollment for patients age 16 or younger

Population: Numbers represent participants enrolled at this time point, other participants were lost to follow-up.

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.

Outcome measures

Measure	Intervention n=2 Participants 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	Control n=1 Participants Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only
Ask Suicide Screening Questions (ASQ) Negative Screen	2 Participants	1 Participants
Ask Suicide Screening Questions (ASQ) Non-Acute Positive Screen	0 Participants	0 Participants
Ask Suicide Screening Questions (ASQ) Acute Positive Screen	0 Participants	0 Participants

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Control

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	Intervention n=5 participants at risk 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	Control n=4 participants at risk Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only
Musculoskeletal and connective tissue disorders Motor Vehicle Accident	0.00% 0/5 • Up to 33 weeks for each participant.	25.0% 1/4 • Number of events 1 • Up to 33 weeks for each participant.

Other adverse events

Measure	Intervention n=5 participants at risk 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	Control n=4 participants at risk Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks Control: Methylcellulose and gelatin capsule only
Psychiatric disorders Increase in Medication	20.0% 1/5 • Number of events 1 • Up to 33 weeks for each participant.	0.00% 0/4 • Up to 33 weeks for each participant.
General disorders Less Headaches	20.0% 1/5 • Number of events 1 • Up to 33 weeks for each participant.	0.00% 0/4 • Up to 33 weeks for each participant.
Gastrointestinal disorders Nausea	40.0% 2/5 • Number of events 2 • Up to 33 weeks for each participant.	0.00% 0/4 • Up to 33 weeks for each participant.
General disorders Headache	0.00% 0/5 • Up to 33 weeks for each participant.	25.0% 1/4 • Number of events 1 • Up to 33 weeks for each participant.
Endocrine disorders Sweating	20.0% 1/5 • Number of events 1 • Up to 33 weeks for each participant.	0.00% 0/4 • Up to 33 weeks for each participant.
Infections and infestations Sore throat, runny nose, congestion	0.00% 0/5 • Up to 33 weeks for each participant.	50.0% 2/4 • Number of events 2 • Up to 33 weeks for each participant.
Renal and urinary disorders Urinary Tract Infection	0.00% 0/5 • Up to 33 weeks for each participant.	25.0% 1/4 • Number of events 1 • Up to 33 weeks for each participant.
Gastrointestinal disorders Constipation	0.00% 0/5 • Up to 33 weeks for each participant.	25.0% 1/4 • Number of events 1 • Up to 33 weeks for each participant.
Immune system disorders Fever	0.00% 0/5 • Up to 33 weeks for each participant.	25.0% 1/4 • Number of events 1 • Up to 33 weeks for each participant.

Additional Information

Dr. Rosemary Claire Roden

Penn State College of Medicine

Phone: 717-531-1383

Email: rroden@pennstatehealth.psu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place