search
Back to results

Evaluation of Naltrexone as a Treatment for Self-injurious Behavior (NTX-SIB)

Primary Purpose

Self-injurious Behavior, Self Mutilation

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Naltrexone
Placebo
Sponsored by
Western Michigan University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Self-injurious Behavior focused on measuring Self-injurious behavior, Self mutilation, naltrexone

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Borgess Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group 1 A-ABAB

Group 2 A-BABA

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Comparison of self-injury rates by condition
naltrexone rate vs. placebo rate

Secondary Outcome Measures

Comparison of self-injury rates by trial within condition
1st naltrexone trial vs. 2nd & 1st placebo trial vs. 2nd

Full Information

First Posted
March 18, 2016
Last Updated
October 31, 2017
Sponsor
Western Michigan University School of Medicine
Collaborators
Kalamazoo Community Foundation
search

1. Study Identification

Unique Protocol Identification Number
NCT02726035
Brief Title
Evaluation of Naltrexone as a Treatment for Self-injurious Behavior
Acronym
NTX-SIB
Official Title
Evaluation of Naltrexone as a Treatment for Self-Injurious Behavior
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Withdrawn
Why Stopped
PI deceased
Study Start Date
February 22, 2014 (Actual)
Primary Completion Date
June 30, 2015 (Anticipated)
Study Completion Date
January 4, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Western Michigan University School of Medicine
Collaborators
Kalamazoo Community Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Self-injurious Behavior, Self Mutilation
Keywords
Self-injurious behavior, Self mutilation, naltrexone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 A-ABAB
Arm Type
Experimental
Arm Description
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.
Arm Title
Group 2 A-BABA
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Naltrexone
Other Intervention Name(s)
Revia
Intervention Description
oral naltrexone 50 mg daily
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
oral placebo (appearing identical to naltrexone) once daily
Primary Outcome Measure Information:
Title
Comparison of self-injury rates by condition
Description
naltrexone rate vs. placebo rate
Time Frame
For each 3 week trial, average rates calculated over weeks 2-3 only (14 day period).
Secondary Outcome Measure Information:
Title
Comparison of self-injury rates by trial within condition
Description
1st naltrexone trial vs. 2nd & 1st placebo trial vs. 2nd
Time Frame
Average rates calculated for weeks 2-3 of each 3 week trial (14 day period)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael R. Liepman, MD
Organizational Affiliation
Western Michigan University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chris A. Karampahtsis, MD, MPH
Organizational Affiliation
Western Michigan University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Borgess Research Institute
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49048
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of Naltrexone as a Treatment for Self-injurious Behavior

We'll reach out to this number within 24 hrs