The proposed study examines the effect of oral naltrexone on self-injurious behavior (SIB) in adolescents and adults of normal intelligence.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
oral naltrexone 50 mg daily
oral placebo (appearing identical to naltrexone) once daily
Borgess Research Institute
Kalamazoo, Michigan, United States
Comparison of self-injury rates by condition
naltrexone rate vs. placebo rate
Time frame: For each 3 week trial, average rates calculated over weeks 2-3 only (14 day period).
Comparison of self-injury rates by trial within condition
1st naltrexone trial vs. 2nd \& 1st placebo trial vs. 2nd
Time frame: Average rates calculated for weeks 2-3 of each 3 week trial (14 day period)
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