Evaluation of Naltrexone as a Treatment for Self-injurious Behavior

NCT02726035 | Withdrawn Phase 4 DMC

• 1 other identifier: BorgessIRB-2014-0672
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Self-injurious Behavior; Self Mutilation

Keywords

Self-injurious behavior; Self mutilation; naltrexone

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Comparison of self-injury rates by trial within condition

  Average rates calculated for weeks 2-3 of each 3 week trial (14 day period)

Study Arms (2)

Group 1 A-ABAB

EXPERIMENTAL

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; Other: Placebo

Group 2 A-BABA

EXPERIMENTAL

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; Other: Placebo

Interventions

Naltrexone DRUG

oral naltrexone 50 mg daily

Also known as: Revia

Group 1 A-ABAB; Group 2 A-BABA

Placebo OTHER

oral placebo (appearing identical to naltrexone) once daily

Group 1 A-ABAB; Group 2 A-BABA

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Unwilling or parent/guardian unwilling to participate in research requirements.

Sponsors & Collaborators

• Western Michigan University School of Medicine: lead
• Kalamazoo Community Foundation: collaborator

Study Sites (1)

Borgess Research Institute

Kalamazoo, Michigan, 49048, United States

Location

MeSH Terms

Conditions

Self-Injurious Behavior; Self Mutilation

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Michael R. Liepman, MD

  Western Michigan University School of Medicine

  PRINCIPAL INVESTIGATOR

• Chris A. Karampahtsis, MD, MPH

  Western Michigan University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2016
• First Posted: April 1, 2016
• Study Start: February 22, 2014
• Primary Completion: June 30, 2015
• Study Completion: January 4, 2017
• Last Updated: November 6, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)