Evaluation of Naltrexone as a Treatment for Self-injurious Behavior

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.

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.