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

Sponsor

Western Michigan University School of Medicine (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02726035

Collaborator

Kalamazoo Community Foundation (Other)

Enrollment

Location

Arms

34.4

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Self-injurious Behavior Self Mutilation	Drug: Naltrexone Other: Placebo	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Evaluation of Naltrexone as a Treatment for Self-Injurious Behavior

Actual Study Start Date :

Feb 22, 2014

Anticipated Primary Completion Date :

Jun 30, 2015

Actual Study Completion Date :

Jan 4, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Borgess Research Institute	Kalamazoo	Michigan	United States	49048

Sponsors and Collaborators

Western Michigan University School of Medicine
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