Acetaminophen and Social Processes

Borderline Personality Disorder Clinical Trial

Official title:

Acetaminophen and Social Pain in Borderline Personality Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02108990
• Other study ID #: 2012HO294
• Secondary ID: KL2RR025754-04
• Status: Completed
• Phase: Phase 2
• Start date: September 2013
• Est. completion date: June 30, 2014

Study information

• Verified date: May 2024
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: June 30, 2014
• Est. primary completion date: June 30, 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Personality Disorders

Intervention

Drug:
• Acetaminophen

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Ohio State University	National Center for Advancing Translational Sciences (NCATS), National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in symptom reports on the PAI-BOR at week 6	Symptom reports on the PAI-BOR.	Baseline, Week 6
Primary	Change from baseline in symptom severity on the Zanarini Rating Scale for Borderline Personality Disorder	Zanarini Rating Scale for Borderline Personality Disorder	Baseline, Week 6
Secondary	Symptom Reports	Each week participants will be emailed a link to complete that will have three surveys.; The Beck Depression Inventory; The Beck Anxiety Inventory; The Inventory of Interpersonal Problems (Aggression and Interpersonal Sensitivity Subscales).; This weekly survey report will also be sent to the participants once after the completion of pharmacotherapy (at the two weeks post cessation treatment).	Baseline, weeks, 1,2,3,4,5,6 and 8.
Secondary	Daily Diary	The importance of these measures will be to assess how rejected, aggressive, and social participants have been in order to determine if acetaminophen affects these proclivities. Participants will report on: hurt feelings, rejection, affect, aggressive feelings, impulsive behaviors, alcohol use, sleep, social interactions, perceived stress, self-esteem	Daily for week 0,1,2, and 3