Evaluation of Naltrexone as a Treatment for Self-injurious Behavior

Self-injurious Behavior Clinical Trial

— NTX-SIB  

Official title:

Evaluation of Naltrexone as a Treatment for Self-Injurious Behavior

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02726035
• Other study ID #: BorgessIRB-2014-0672
• Status: Withdrawn
• Phase: Phase 4
• First received: March 18, 2016
• Last updated: October 31, 2017
• Start date: February 22, 2014
• Est. completion date: January 4, 2017

Study information

• Verified date: October 2017
• Source: Western Michigan University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 4, 2017
• Est. primary completion date: June 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Self Mutilation
• Self-injurious Behavior

Intervention

Drug:
• Naltrexone
oral naltrexone 50 mg daily

Other:
• Placebo
oral placebo (appearing identical to naltrexone) once daily

Locations

Country	Name	City	State
United States	Borgess Research Institute	Kalamazoo	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Western Michigan University School of Medicine	Kalamazoo Community Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)