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Self-Injury: Diagnosis and Treatment
This study is ongoing, but not recruiting participants.
Study NCT00065936   Information provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First Received: August 1, 2003   Last Updated: June 23, 2005   History of Changes

August 1, 2003
June 23, 2005
July 1997
 
 
 
Complete list of historical versions of study NCT00065936 on ClinicalTrials.gov Archive Site
 
 
 
Self-Injury: Diagnosis and Treatment
Behavioral and Biochemical Mechanisms of Self-Injury

Self-injurious behavior is behavior in which a person hurts or harms himself. This behavior sometimes occurs in people with mental retardation or autism. This study will evaluate self-injurious behavior in people with mental retardation or autism and will test the effectiveness of new treatments.

It is unknown why some people with mental retardation and/or autism repeatedly and persistently injure themselves, some to the point of tissue damage and permanent scarring. Unraveling this mystery poses paradoxical biomedical and behavioral science questions and creates deeply troubling problems for practitioners and family members of affected individuals. Over the past decade, many cases of self-injurious behavior (SIB) have been treated successfully using behavioral interventions that teach communication and other functional skills. However, practical problems of implementation, costs associated with long-term treatment, and cases with no clear social profile suggest that there is still much to be learned about why people self-injure. Some forms of self-injury may involve intense stimulation of body sites sufficient to elicit the release and receptor binding of endogenous opioid peptides. This study will evaluate variables common to SIB and the neurophysiology of pain regulation. The study will also clarify the role of the endogenous opioids and pain mechanisms in self-injury.

Participants with mild to profound mental retardation and/or autism will be observed for frequency of self-injury, duration and intensity of self-injurious behavior, and where on the body that behavior is directed. Following this characterization, participants’ saliva will be noninvasively examined for substance P, met-enkephalin, and cortisol as markers for altered pain transmission and predictors of response to treatment. After screening and SIB subtyping (i.e., social, nonsocial, or mixed), 37 participants whose self-injury is primarily nonsocial or mixed will be evaluated over 16 weeks. Participants will be randomized to receive either transcutaneous electric nerve stimulation (TENS, an opioid agonist treatment) or naltrexone (an opioid antagonist treatment). Participants whose self-injury is primarily socially motivated will be evaluated with TENS and will receive behavioral interventions through a technical assistance service delivery model. Follow-up evaluations will occur at Months 3 and 6.

Phase III
Interventional
Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
  • Self-Injurious Behavior
  • Mental Retardation
  • Drug: Naltrexone hydrochloride
  • Procedure: Transcutaneous sensory nerve stimulation
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
37
June 2002
 

Inclusion Criteria

  • Self-injurious behavior for at least 3 months prior to study entry
  • Normal cardiac, liver, and kidney function as determined by a physician

Exclusion Criteria

  • Only presenting problems are pica, aggression, property destruction, hyperkinesis, screaming, or eating disorders
  • Lesch-Nyhan syndrome
  • Peripheral neuropathy
  • Self-injury that presents immediate imminent risk such as loss of sight or hearing or other potentially life threatening behavior
  • Serious chronic health impairments associated with specific syndromes (e.g., Cornelia de Lange, Prader Willi Syndrome)
  • Self-injury unresponsive to prior conventional behavioral or pharmacological interventions (e.g., less than 50% reduction in overall self-injury for 3 months)
  • Major depressive disorder or schizophrenia
Both
4 Years to 25 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00065936
 
R29HD35862, R29 HD35862, NICHD-0525
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
 
Principal Investigator: Frank Symons, Ph.D. University of North Carolina
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
May 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP