Naltrexone in Borderline Personality Disorder

Study Overview
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Brief Summary
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The purpose of this study is to investigate whether naltrexone reduces the intensity and duration of flashbacks and dissociative states in patients with borderline personality disorder.

Official Title
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Evaluation of the Efficacy of the Opioid Antagonist Naltrexone on the Incidence and Intensity of Flashbacks and Dissociative States in Patients With Borderline Personality Disorder

Conditions
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Borderline Personality Disorder

Intervention / Treatment
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* Drug: Naltrexone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: In- and Outpatients:Borderline personality disorder according to the Diagnostic and Statistical Manual for Mental Disorders, 4.Edition (DSM IV) DES-(Dissociative Experience Scale)-score: > or equal 18 according to amendment4 (former value according to amendment 2 was > or equal 25). Urinary test of opiates negative No psychopharmacological treatment for two weeks prior to study (fluoxetine four weeks) No Lithium for two months Exclusion Criteria: Lifetime diagnosis of psychotic disorder Current major depressive disorder (MDD) Lifetime diagnosis opioid dependence or current opioid abuse (10 to 7 days prior to study) Comedication with opioid analgetics Known naltrexone intolerance Liver disease Pregnancy and lactation period Other severe medical or neurological diseases Simultaneous participation in another study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Blinded sequential administration: naltrexon 50 mg (3 weeks)- placebo (3 weeks)- placebo (1 week) | Drug: Naltrexone<br>* Daily oral administration (capsules): 50mg naltrexone and placebo or 200mg naltrexone and placebo or placebo and naltrexon 50mg or placebo and 200mg naltrexone<br>|
| Other: 2<br>Blinded sequential administration: 200mg naltrexone (3 weeks) - placebo (3 weeks)- placebo (1 week) | Drug: Naltrexone<br>* Daily oral administration (capsules): 50mg naltrexone and placebo or 200mg naltrexone and placebo or placebo and naltrexon 50mg or placebo and 200mg naltrexone<br>|
| Other: 3<br>Blinded sequential administration: placebo (3 weeks) - 200mg naltrexone (3 weeks) - placebo (1 week) | Drug: Naltrexone<br>* Daily oral administration (capsules): 50mg naltrexone and placebo or 200mg naltrexone and placebo or placebo and naltrexon 50mg or placebo and 200mg naltrexone<br>|
| Other: 4<br>Blinded sequential administration: placebo (3 weeks) - 50mg naltrexone (3 weeks) - placebo (1 week) | Drug: Naltrexone<br>* Daily oral administration (capsules): 50mg naltrexone and placebo or 200mg naltrexone and placebo or placebo and naltrexon 50mg or placebo and 200mg naltrexone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of dissociative symptoms |  | End of 3rd week treatment of naltrexon | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of flashbacks |  | End of 3rd week treatment of naltrexone | 
| Reduction of self-injurious behavior |  | End of 3rd week treatment of naltrexone | 
| Reduction of psychopathology (depression, anxiety, anger, borderline symptoms) |  | End of 3rd week treatment of naltrexone | 
| Safety regarding liver enzyme elevation |  | End of 3rd week treatment of naltrexone | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dissociation, Flashbacks, Self-injurious behavior