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

Evaluation of Naltrexone as a Treatment for Self-Injurious Behavior

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

Study Overview

• Status: Withdrawn
• Conditions: Self Mutilation; Self-injurious Behavior
• Intervention / Treatment: Drug: Naltrexone; Other: Placebo

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.

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Kalamazoo, Michigan, United States, 49048
      • Borgess Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Naltrexone; oral naltrexone 50 mg daily; Other Names: Revia; Other: Placebo; oral placebo (appearing identical to naltrexone) once daily
Experimental: 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.	Drug: Naltrexone; oral naltrexone 50 mg daily; Other Names: Revia; Other: Placebo; oral placebo (appearing identical to naltrexone) once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of self-injury rates by condition	naltrexone rate vs. placebo rate	For each 3 week trial, average rates calculated over weeks 2-3 only (14 day period).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of self-injury rates by trial within condition	1st naltrexone trial vs. 2nd & 1st placebo trial vs. 2nd	Average rates calculated for weeks 2-3 of each 3 week trial (14 day period)

Collaborators and Investigators

• Sponsor: Western Michigan University School of Medicine
• Collaborators: Kalamazoo Community Foundation
• Investigators: Principal Investigator: Michael R. Liepman, MD, Western Michigan University School of Medicine; Principal Investigator: Chris A. Karampahtsis, MD, MPH, Western Michigan University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2014
• Primary Completion (Anticipated): June 30, 2015
• Study Completion (Actual): January 4, 2017

Study Registration Dates

• First Submitted: March 18, 2016
• First Submitted That Met QC Criteria: March 28, 2016
• First Posted (Estimate): April 1, 2016

Study Record Updates

• Last Update Posted (Actual): November 6, 2017
• Last Update Submitted That Met QC Criteria: October 31, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Self-injurious behavior; naltrexone; Self mutilation
• Additional Relevant MeSH Terms: Behavioral Symptoms; Wounds and Injuries; Self-Injurious Behavior; Self Mutilation; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Narcotic Antagonists; Alcohol Deterrents; Naltrexone
• Other Study ID Numbers: BorgessIRB-2014-0672

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No