Self-injurious Behavior, Self Mutilation
Conditions
Keywords
Self-injurious behavior, Self mutilation, naltrexone
Brief summary
The proposed study examines the effect of oral naltrexone on self-injurious behavior (SIB) in adolescents and adults of normal intelligence.
Detailed description
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.
Interventions
DRUGNaltrexone
oral naltrexone 50 mg daily
OTHERPlacebo
oral placebo (appearing identical to naltrexone) once daily
Sponsors
Kalamazoo Community Foundation
Western Michigan University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of self-injury rates by condition | For each 3 week trial, average rates calculated over weeks 2-3 only (14 day period). | naltrexone rate vs. placebo rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of self-injury rates by trial within condition | Average rates calculated for weeks 2-3 of each 3 week trial (14 day period) | 1st naltrexone trial vs. 2nd & 1st placebo trial vs. 2nd |
Countries
United States
Outcome results
None listed