Health TrialsbyHealthPanel

Trial to Evaluate the Effects of Naltrexone in Nonsuicidal Self-injury

ConditionNonsuicidal Self-Injury
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age16+
SponsorSeoul National University Hospital

About this trial

The goal of this clinical trial is to learn if naltrexone works to treat nonsuicidal self-injurious behavior in adolescents and adults.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age: 16 years of age or older

Clinical interviews meet DSM-5's nonsuicidal self-injury diagnostic criteria

Nonsuicidal self-injurious behavior has been observed more than once in the past two months

Obsessive Compulsive Drinking Scale general craving item 2 or more points (strong desire)

Disqualifiers

currently in psychotic or manic conditions

currently experiencing serious suicidal thoughts

history of substance-related disorders including opioid

do not agree to use very effective contraception from the time of signing the test subject's consent form to the end of study period (non-fertility women and postmenopausal women excluded from the contraception requirements)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Naltrexone

    Drug

    naltrexone 50mg for 6 weeks

  • Placebo

    Drug

    placebo for 6 weeks

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: experimental groupExperimental treatment 1 intervention
Group B: comparison groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Frequency of nonsuicidal self-injurous behavior

Total number of nonsuicidal self-injurous behavior during study period

Time frame
6 weeks

Secondary outcomes

1

Deliberate Self-harm Inventory

change of NSSI frequency acquired by Deliberate Self-harm Inventory (the outcome of this scale does not have score)

Time frame
6 weeks
2

Clinical Global Impressions

change of Clinical Global Impressions scale the minimum and maximum values are 1 to 7, higher scores mean worse outcome

Time frame
6 weeks
3

Obsessive Compulsive Drinking Scale

change of Obsessive Compulsive Drinking Scale the minimum and mixiumum values are 0 to 40, higher scores mean a worse outcome

Time frame
6 weeks
4

Eating Disorder Examination-Questionnaire

change of Eating Disorder Examination-Questionnaire the minimum and mixiumum values are 0 to 6, higher scores mean a worse outcome

Time frame
6 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Seoul National University Hospital

Lead sponsor

Whanin Pharmaceutical Company

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: