Acetaminophen and Social Processes

Phase 2

Completed

• Conditions: Borderline Personality Disorder
• Interventions: Drug: Acetaminophen

• Registration Number: NCT02108990
• Lead Sponsor: Ohio State University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2014-04-07
• Study First Submitted QC: 2014-04-07
• Study First Posted: 2014-04-09
• Primary Completion: 2014-06-30
• Study Completion: 2014-06-30
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-31
• Last Update Posted: 2024-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 9

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Acetaminophen 1000mg	Acetaminophen	Acetaminophen 1000mg capsule orally three times a day

Primary Outcome Measures

Name	Time	Method
Change from baseline in symptom reports on the PAI-BOR at week 6	Baseline, Week 6	Symptom reports on the PAI-BOR.
Change from baseline in symptom severity on the Zanarini Rating Scale for Borderline Personality Disorder	Baseline, Week 6	Zanarini Rating Scale for Borderline Personality Disorder

Secondary Outcome Measures

Name	Time	Method
Symptom Reports	Baseline, weeks, 1,2,3,4,5,6 and 8.	Each week participants will be emailed a link to complete that will have three surveys.; 1. The Beck Depression Inventory; 2. The Beck Anxiety Inventory; 3. 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).
Daily Diary	Daily for week 0,1,2, and 3	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

Trial Locations

Locations (1)

The Ohio State University; 🇺🇸 Columbus, Ohio, United States