Evaluation of Naltrexone as a Treatment for Self-injurious Behavior

Study Overview
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Brief Summary
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The proposed study examines the effect of oral naltrexone on self-injurious behavior (SIB) in adolescents and adults of normal intelligence.

Detailed Description
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The proposed study examines the effect of oral naltrexone on self-injurious behavior (SIB) in adolescents and adults of normal intelligence. It is designed as a pilot study and will provide preliminary data for a larger scale clinical trial if found to be effective in the pilot study.

Official Title
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Evaluation of Naltrexone as a Treatment for Self-Injurious Behavior

Conditions
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Self-injurious Behavior, Self Mutilation

Intervention / Treatment
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* Drug: Naltrexone
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Thirteen years of age or older Actively engaged in SIB at a rate of, on average, at least two events per week for at least 3 months Has internet access in a secure and private manner Lives within a reasonable distance from Kalamazoo (to make the five clinic visits convenient) and plans to remain in the area throughout the next 4-5 months Exclusion Criteria: Under the age of 13 Currently pregnant (confirmed with initial urine pregnancy test), lactating, or planning to become pregnant in the next 4 months Active hepatitis or liver disease Prior history of recently active opioid dependence Current prescription, non-prescription, or illicit opioid use, (i.e., acute use within the past 14 days or chronic use within the last 30 days), including all opioid analgesics, certain cough and cold remedies (e.g., codeine), and certain anti-diarrheal preparations (e.g., loperamide). Currently taking an opioid antagonist for alcohol or opioid dependence or having taken one in the last 14 days Current use of leflunomide (Arava), droperidol (Droleptan), diazepam (Valium), thioridazine (Mellaril, Novoridazine, Thioril) (26) Any report of clinically significant medical condition or medication regimen which might cause undue risk or affect ability to participate in this clinical trial On initial laboratory examination, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels more than one standard deviation (SD) above the upper limit of normal Unable to meet a 22-week requirement to log journal entries daily, to be available by phone a minimum of once weekly during the first month, and to be present at clinical sites once every three weeks for 12 weeks, for a total of 5 visits Infrequent SIB, lack of secure Internet access, or living a significant distance from the Kalamazoo area (does not meet inclusion criteria) Unwilling or parent/guardian unwilling to participate in research requirements.

Ages Eligible for Study
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Minimum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1 A-ABAB<br>After 4 week open label oral naltrexone run-in, participants are randomized to 2 groups (50% each). Group 1 will receive oral naltrexone 50 mg daily during weeks 5-7 (3 weeks). They will switch to placebo for weeks 8-10, then return to naltrexone for weeks 11-13, then placebo for weeks 14-16 (i.e., A-ABAB double crossover design, participants act as own controls). Study drug and placebo will be encapsulated so as to appear identical. | Drug: Naltrexone<br>* oral naltrexone 50 mg daily<br>* Other names: Revia;Other: Placebo<br>* oral placebo (appearing identical to naltrexone) once daily<br>|
| Experimental: Group 2 A-BABA<br>After 4 week open label oral naltrexone run-in, participants are randomized to 2 groups (50% each). Group 2 will receive oral placebo once daily during weeks 5-7. They will then be switched to oral naltrexone 50 mg daily for weeks 8-10, then return to placebo for weeks 11-13, then naltrexone for weeks 14-16 (i.e., A-BABA double crossover design, participants act as own controls). Study drug and placebo will be encapsulated so as to appear identical. | Drug: Naltrexone<br>* oral naltrexone 50 mg daily<br>* Other names: Revia;Other: Placebo<br>* oral placebo (appearing identical to naltrexone) once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of self-injury rates by condition | naltrexone rate vs. placebo rate | For each 3 week trial, average rates calculated over weeks 2-3 only (14 day period). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of self-injury rates by trial within condition | 1st naltrexone trial vs. 2nd & 1st placebo trial vs. 2nd | Average rates calculated for weeks 2-3 of each 3 week trial (14 day period) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Self-injurious behavior, Self mutilation, naltrexone