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

Western Michigan University School of Medicine

Status and phase: Withdrawn; Phase 4

Conditions: Self-injurious Behavior; Self Mutilation

Treatments: Drug: Naltrexone; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02726035

BorgessIRB-2014-0672

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 13+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

0 participants in 2 patient groups

Group 1 A-ABAB

Experimental group

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.

Treatment:

Other: Placebo

Drug: Naltrexone

Group 2 A-BABA

Experimental group

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.

Treatment:

Other: Placebo

Drug: Naltrexone