Clinical trial NCT02726035: Evaluation of Naltrexone as a Treatment for Self-injurious Behavior
Official title: Evaluation of Naltrexone as a Treatment for Self-Injurious Behavior
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Self-injurious Behavior
Self Mutilation
Keywords: Self-injurious behavior
Self mutilation
naltrexone
Lead sponsor: Western Michigan University School of Medicine
Sponsor class: OTHER
Collaborators: name: Kalamazoo Community Foundation
First posted: 2016-04-01
Enrollment: 0
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Thirteen years of age or older
* 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

Exclusion Criteria:

* Under the age of 13
* 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
* Infrequent SIB, lack of secure Internet access, or living a significant distance from the Kalamazoo area (does not meet inclusion criteria)
* Unwilling or parent/guardian unwilling to participate in research requirements.

Primary outcomes:
measure: Comparison of self-injury rates by condition
timeFrame: For each 3 week trial, average rates calculated over weeks 2-3 only (14 day period).
Secondary outcomes:
measure: Comparison of self-injury rates by trial within condition
timeFrame: Average rates calculated for weeks 2-3 of each 3 week trial (14 day period)
Other outcomes:
Locations:
city: Kalamazoo
country: United States
facility: Borgess Research Institute
state: Michigan
Study officials:
affiliation: Western Michigan University School of Medicine
name: Michael R. Liepman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Western Michigan University School of Medicine
name: Chris A. Karampahtsis, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: