Evaluation of Naltrexone as a Treatment for Self-injurious Behavior

Phase 4

Withdrawn

• Conditions: Self-injurious Behavior; Self Mutilation
• Interventions: Drug: Naltrexone; Other: Placebo

• Registration Number: NCT02726035
• Lead Sponsor: Western Michigan University School of Medicine

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.

Study Timeline

• Study Start: 2014-02-22
• Primary Completion: 2015-06-30
• Study First Submitted: 2016-03-18
• Study First Submitted QC: 2016-03-28
• Study First Posted: 2016-04-01
• Study Completion: 2017-01-04
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-31
• Last Update Posted: 2017-11-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1 A-ABAB	Placebo	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.
Group 2 A-BABA	Placebo	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.
Group 1 A-ABAB	Naltrexone	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.
Group 2 A-BABA	Naltrexone	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Borgess Research Institute; 🇺🇸 Kalamazoo, Michigan, United States