Clinical trial NCT02108990: Acetaminophen and Social Processes
Official title: Acetaminophen and Social Pain in Borderline Personality Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Borderline Personality Disorder
Keywords: borderline personality disorder
rejection
social pain
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
name: National Center for Research Resources (NCRR)
First posted: 2014-04-09
Enrollment: 9
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Recent research has identified heightened sensitivity to social rejection as a core feature of BPD. Rejection sensitivity can trigger the aggressive, impulsive, and self-injurious behaviors characteristic of the disorder.

Therefore targeting therapy towards the reduction of rejection sensitivity may improve the low rates of effectiveness of current pharmacological and behavioral therapies. Therefore, this proposal tests a theoretically-based pharmacological approach that specifically targets the heightened sensitivity to rejection experienced by BPD patients.

In prior research with normal controls, it was shown that chronic treatment with the physical pain-killer acetaminophen (e.g. Tylenol) reduced both neural responses to social rejection (using fMRI) as well as self-reported feelings of rejection in a daily diary study.

It is the aim of this research project to determine if the over-the-counter analgesic, acetaminophen (active ingredient in Tylenol), can reduce symptoms and behaviors in BPD patients. The goal of this proposal is to use an open-label design to determine if acetaminophen improves symptoms in BPD patients.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of borderline personality disorder
* 18 years or older
* if on psychiatric medication, must be on a stable dose
* able to swallow tablets

Exclusion Criteria:

* current, primary substance abuse, particularly alcoholism
* current eating disorder
* history or current psychotic disorder
* suicidal ideation or behavior requiring imminent inpatient treatment
* pregnancy
* Participants whose medication has not been stable for more than 4 weeks
* Impaired liver function (\> 1.25x the upper limit of the reference range)
* Conditions that can affect immune system functioning.

Primary outcomes:
measure: Change from baseline in symptom reports on the PAI-BOR at week 6
timeFrame: Baseline, Week 6
measure: Change from baseline in symptom severity on the Zanarini Rating Scale for Borderline Personality Disorder
timeFrame: Baseline, Week 6
Secondary outcomes:
measure: Symptom Reports
timeFrame: Baseline, weeks, 1,2,3,4,5,6 and 8.
measure: Daily Diary
timeFrame: Daily for week 0,1,2, and 3
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Baldwin M Way, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ohio State University
name: Jennifer S. Cheavens, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dewall CN, Macdonald G, Webster GD, Masten CL, Baumeister RF, Powell C, Combs D, Schurtz DR, Stillman TF, Tice DM, Eisenberger NI. Acetaminophen reduces social pain: behavioral and neural evidence. Psychol Sci. 2010 Jul;21(7):931-7. doi: 10.1177/0956797610374741. Epub 2010 Jun 14.