Self-Injurious BehaviorPhase 3NCT00065936
Self-Injury: Diagnosis and Treatment
A Phase 3 study testing Naltrexone hydrochloride and Transcutaneous sensory nerve stimulation in people with Self-Injurious Behavior and Mental Retardation, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 25 years
- Conditions the study is for
- Self-Injurious Behavior, Mental Retardation
- What is being tested?
- Naltrexone hydrochloride and Transcutaneous sensory nerve stimulation
- Type of treatment
- Surgery or procedure
- How many people
- 37 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 1997to Jun 2002
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Self-injurious behavior for at least 3 months prior to study entry
- Normal cardiac, liver, and kidney function as determined by a physician
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Frank Porter Graham Child Development Center, University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Research Training Institute, Western Carolina Center
Morganton, North Carolina, 28655
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Self-Injurious Behavior, Mental Retardation
- Being tested
- Naltrexone hydrochloride, Transcutaneous sensory nerve stimulation
- Keywords
- Intractable self-injurious behavior, Naltrexone, Transcutaneous electrical nerve stimulation, Substance P, Met-enkephalin, Cortisol
- Medical subject headings
- Self-Injurious Behavior, Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naltrexone hydrochlorideDrug
Transcutaneous sensory nerve stimulationProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2003 (estimated)
- Study startJul 1997
- Study completionJun 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Self-Injurious BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 37 participants
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Investigators
- Frank Symons, Ph.D., Principal investigator, University of North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00065936
- Sponsor's protocol ID
- R29HD35862
- Other IDs
- R29 HD35862, NICHD-0525
- Status last verified
- May 2003
- First submitted
- 1 Aug 2003
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
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.
PubMed 10463024Symons 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.
PubMed 12475363Breau 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.
PubMed 12756380
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral and Biochemical Mechanisms of Self-Injury
- ClinicalTrials.gov ID
- NCT00065936
- Acronym / sponsor ID
- R29HD35862
- Conditions
- Self-Injurious Behavior, Mental Retardation
- Keywords
- Intractable self-injurious behavior, Naltrexone, Transcutaneous electrical nerve stimulation, Substance P, Met-enkephalin, Cortisol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 37 participants
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- Jul 1997
- Study completion
- Jun 2002
- First posted
- 5 Aug 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 4 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Self-injurious behavior for at least 3 months prior to study entry
- Normal cardiac, liver, and kidney function as determined by a physician
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Naltrexone hydrochloride | Drug | – |
| Transcutaneous sensory nerve stimulation | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
- Background: PubMed 10463024Symons 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.
- Background: PubMed 12475363Symons 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.
- Background: PubMed 12756380Breau 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Symons, Ph.D. principal investigator
University of North Carolina
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Naltrexone hydrochloride and Transcutaneous sensory nerve stimulation in people with Self-Injurious Behavior and Mental Retardation, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00065936, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.