Self-injurious BehaviorPhase 4NTX-SIBNCT02726035
Evaluation of Naltrexone as a Treatment for Self-injurious Behavior
A Phase 4 study testing Naltrexone in people with Self-injurious Behavior and Self Mutilation, run by Western Michigan University School of Medicine at 1 site in United States.
Trial summary
The proposed study examines the effect of oral naltrexone on self-injurious behavior (SIB) in adolescents and adults of normal intelligence. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Self-injurious Behavior, Self Mutilation
- What is being tested?
- Naltrexone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2014to 4 Jan 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
Borgess Research Institute
Kalamazoo, Michigan, 49048
About this study
Official title: Evaluation of Naltrexone as a Treatment for Self-Injurious Behavior
The proposed study examines the effect of oral naltrexone on self-injurious behavior (SIB) in adolescents and adults of normal intelligence.
Read the 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.
- Conditions
- Self-injurious Behavior, Self Mutilation
- Being tested
- Naltrexone, Placebo
- Keywords
- Self-injurious behavior, Self mutilation, naltrexone
- Medical subject headings
- Self-Injurious Behavior, Self Mutilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaltrexoneDrug
Also called Revia
oral naltrexone 50 mg daily
PlaceboOther
oral placebo (appearing identical to naltrexone) once daily
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Naltrexone; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of self-injury rates by condition
naltrexone rate vs. placebo rate
Measured: 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
1st naltrexone trial vs. 2nd \& 1st placebo trial vs. 2nd
Measured: Average rates calculated for weeks 2-3 of each 3 week trial (14 day period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2016 (estimated)
- Study start22 Feb 2014
- Primary completion30 Jun 2015 (estimated)
- Study completion4 Jan 2017
Why it stopped: PI deceased
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self-injurious BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western Michigan University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Kalamazoo Community Foundation
- Responsible party
- Sponsor
- Investigators
- Michael R. Liepman, MD, Principal investigator, Western Michigan University School of MedicineChris A. Karampahtsis, MD, MPH, Principal investigator, Western Michigan University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02726035
- Sponsor's protocol ID
- BorgessIRB-2014-0672
- Acronym
- NTX-SIB
- Status last verified
- Oct 2017
- First submitted
- 18 Mar 2016
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Naltrexone as a Treatment for Self-Injurious Behavior
- ClinicalTrials.gov ID
- NCT02726035
- Acronym / sponsor ID
- NTX-SIB / BorgessIRB-2014-0672
- Conditions
- Self-injurious Behavior, Self Mutilation
- Keywords
- Self-injurious behavior, Self mutilation, naltrexone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI deceased
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Western Michigan University School of MedicineUniversity, hospital or other
- Collaborators
- Kalamazoo Community Foundation
- Study start
- 22 Feb 2014 (actual)
- Primary completion
- 30 Jun 2015 (estimated)
- Study completion
- 4 Jan 2017 (actual)
- First posted
- 1 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 A-ABAB | Experimental | Drug: Naltrexone, Other: PlaceboAfter 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 | Experimental | Drug: Naltrexone, Other: PlaceboAfter 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. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NaltrexoneAlso: Reviaoral naltrexone 50 mg daily | Drug | Group 1 A-ABAB, Group 2 A-BABA |
| Placebooral placebo (appearing identical to naltrexone) once daily | Other | Group 1 A-ABAB, Group 2 A-BABA |
Primary outcome
Comparison of self-injury rates by condition
Time frame: For each 3 week trial, average rates calculated over weeks 2-3 only (14 day period).
naltrexone rate vs. placebo rate
1 secondary outcome
Comparison of self-injury rates by trial within condition
Time frame: Average rates calculated for weeks 2-3 of each 3 week trial (14 day period)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael R. Liepman, MD principal investigator
Western Michigan University School of Medicine
Chris A. Karampahtsis, MD, MPH principal investigator
Western Michigan University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Naltrexone in people with Self-injurious Behavior and Self Mutilation, run by Western Michigan University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of self-injury rates by condition (time frame: For each 3 week trial, average rates calculated over weeks 2-3 only (14 day period).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.