Naltrexone in Borderline Personality Disorder

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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00124839

Enrollment

Registered

2005-07-28

Start date

2005-10-31

Completion date

2008-03-31

Last updated

2008-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Borderline Personality Disorder

Keywords

Dissociation, Flashbacks, Self-injurious behavior

Brief summary

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.

Interventions

DRUGNaltrexone

Daily oral administration (capsules): 50mg naltrexone and placebo or 200mg naltrexone and placebo or placebo and naltrexon 50mg or placebo and 200mg naltrexone

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Reduction of dissociative symptoms	End of 3rd week treatment of naltrexon

Secondary

Measure	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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026