NCT00065936

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
37

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 1997

Longer than P75 for phase_3

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1997

Completed
4.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2002

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 1, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2003

Completed
Last Updated

June 24, 2005

Status Verified

May 1, 2003

First QC Date

August 1, 2003

Last Update Submit

June 23, 2005

Conditions

Self-Injurious BehaviorMental Retardation

Keywords

Intractable self-injurious behaviorNaltrexoneTranscutaneous electrical nerve stimulationSubstance PMet-enkephalinCortisol

Interventions

Naltrexone hydrochlorideDRUG
Transcutaneous sensory nerve stimulationPROCEDURE

Eligibility Criteria

Age4 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Frank Porter Graham Child Development Center, University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Research Training Institute, Western Carolina Center

Morganton, North Carolina, 28655, United States

Location

Related Publications (3)

  • Symons FJ, Koppekin A, Wehby JH. Treatment of self-injurious behavior and quality of life for persons with mental retardation. Ment Retard. 1999 Aug;37(4):297-307. doi: 10.1352/0047-6765(1999)0372.0.CO;2.

    PMID: 10463024BACKGROUND

  • Symons FJ, Sutton KA, Walker C, Bodfish JW. Altered diurnal pattern of salivary substance P in adults with developmental disabilities and chronic self-injury. Am J Ment Retard. 2003 Jan;108(1):13-8. doi: 10.1352/0895-8017(2003)1082.0.CO;2.

    PMID: 12475363BACKGROUND

  • Breau LM, Camfield CS, Symons FJ, Bodfish JW, Mackay A, Finley GA, McGrath PJ. Relation between pain and self-injurious behavior in nonverbal children with severe cognitive impairments. J Pediatr. 2003 May;142(5):498-503. doi: 10.1067/mpd.2003.163.

    PMID: 12756380BACKGROUND

MeSH Terms

Conditions

Self-Injurious BehaviorIntellectual Disability

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

NaloxoneMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Frank Symons, Ph.D.

    University of North Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

August 1, 2003

First Posted

August 5, 2003

Study Start

July 1, 1997

Study Completion

June 1, 2002

Last Updated

June 24, 2005

Record last verified: 2003-05

Locations

US(2)