Clinical Trial: Evaluation of Naltrexone as a Treatment for Self-injurious Behavior

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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

Detailed Summary: 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.
Sponsor: Western Michigan University School of Medicine

Current Primary Outcome: Comparison of self-injury rates by condition [ Time Frame: For each 3 week trial, average rates calculated over weeks 2-3 only (14 day period). ]

naltrexone rate vs. placebo rate


Original Primary Outcome: Same as current

Current Secondary Outcome: Comparison of self-injury rates by trial within condition [ Time Frame: 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


Original Secondary Outcome: Same as current

Information By: Western Michigan University School of Medicine

Dates:
Date Received: March 18, 2016
Date Started: September 2016
Date Completion: September 2018
Last Updated: April 3, 2016
Last Verified: April 2016