Evaluation of Naltrexone as a Treatment for Self-injurious Behavior
NCT ID: NCT02726035
Last Updated: 2017-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE4
INTERVENTIONAL
2014-02-22
2017-01-04
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Group 1 A-ABAB
After 4 week open label oral naltrexone run-in, participants are randomized to 2 groups (50% each). Group 1 will receive oral naltrexone 50 mg daily during weeks 5-7 (3 weeks). They will switch to placebo for weeks 8-10, then return to naltrexone for weeks 11-13, then placebo for weeks 14-16 (i.e., A-ABAB double crossover design, participants act as own controls). Study drug and placebo will be encapsulated so as to appear identical.
Naltrexone
oral naltrexone 50 mg daily
Placebo
oral placebo (appearing identical to naltrexone) once daily
Group 2 A-BABA
After 4 week open label oral naltrexone run-in, participants are randomized to 2 groups (50% each). Group 2 will receive oral placebo once daily during weeks 5-7. They will then be switched to oral naltrexone 50 mg daily for weeks 8-10, then return to placebo for weeks 11-13, then naltrexone for weeks 14-16 (i.e., A-BABA double crossover design, participants act as own controls). Study drug and placebo will be encapsulated so as to appear identical.
Naltrexone
oral naltrexone 50 mg daily
Placebo
oral placebo (appearing identical to naltrexone) once daily
Interventions
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Naltrexone
oral naltrexone 50 mg daily
Placebo
oral placebo (appearing identical to naltrexone) once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Actively engaged in SIB at a rate of, on average, at least two events per week for at least 3 months
* Has internet access in a secure and private manner
* Lives within a reasonable distance from Kalamazoo (to make the five clinic visits convenient) and plans to remain in the area throughout the next 4-5 months
* Unwilling or parent/guardian unwilling to participate in research requirements.
Exclusion Criteria
* Currently pregnant (confirmed with initial urine pregnancy test), lactating, or planning to become pregnant in the next 4 months
* Active hepatitis or liver disease
* Prior history of recently active opioid dependence
* Current prescription, non-prescription, or illicit opioid use, (i.e., acute use within the past 14 days or chronic use within the last 30 days), including all opioid analgesics, certain cough and cold remedies (e.g., codeine), and certain anti-diarrheal preparations (e.g., loperamide). Currently taking an opioid antagonist for alcohol or opioid dependence or having taken one in the last 14 days
* Current use of leflunomide (Arava), droperidol (Droleptan), diazepam (Valium), thioridazine (Mellaril, Novoridazine, Thioril) (26)
* Any report of clinically significant medical condition or medication regimen which might cause undue risk or affect ability to participate in this clinical trial
* On initial laboratory examination, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels more than one standard deviation (SD) above the upper limit of normal
* Unable to meet a 22-week requirement to log journal entries daily, to be available by phone a minimum of once weekly during the first month, and to be present at clinical sites once every three weeks for 12 weeks, for a total of 5 visits
13 Years
ALL
No
Sponsors
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Kalamazoo Community Foundation
OTHER
Western Michigan University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Michael R. Liepman, MD
Role: PRINCIPAL_INVESTIGATOR
Western Michigan University School of Medicine
Chris A. Karampahtsis, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Western Michigan University School of Medicine
Locations
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Borgess Research Institute
Kalamazoo, Michigan, United States
Countries
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Other Identifiers
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BorgessIRB-2014-0672
Identifier Type: -
Identifier Source: org_study_id