Acetaminophen and Social Processes

Acetaminophen and Social Pain in Borderline Personality Disorder

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.

Study Overview

• Status: Completed
• Conditions: Borderline Personality Disorder
• Intervention / Treatment: Drug: Acetaminophen

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acetaminophen 1000mg; Acetaminophen 1000mg capsule orally three times a day	Drug: Acetaminophen; Other Names: Tylenol
Experimental: Acetaminophen 500mg; 500mg Acetaminophen orally three times a day	Drug: Acetaminophen; Other Names: Tylenol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in symptom reports on the PAI-BOR at week 6	Symptom reports on the PAI-BOR.	Baseline, Week 6
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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

Collaborators and Investigators

• Sponsor: Ohio State University
• Collaborators: National Center for Research Resources (NCRR); National Center for Advancing Translational Sciences (NCATS)
• Investigators: Principal Investigator: Baldwin M Way, Ph.D., Ohio State University; Principal Investigator: Jennifer S. Cheavens, Ph.D., Ohio State University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): June 30, 2014
• Study Completion (Actual): June 30, 2014

Study Registration Dates

• First Submitted: April 7, 2014
• First Submitted That Met QC Criteria: April 7, 2014
• First Posted (Estimate): April 9, 2014

Study Record Updates

• Last Update Posted (Actual): October 17, 2022
• Last Update Submitted That Met QC Criteria: October 10, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: rejection; borderline personality disorder; social pain
• Additional Relevant MeSH Terms: Mental Disorders; Personality Disorders; Borderline Personality Disorder; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Acetaminophen
• Other Study ID Numbers: 2012HO294; KL2RR025754-04 (U.S. NIH Grant/Contract)