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Acetaminophen and Social Processes

Primary Purpose

Borderline Personality Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Acetaminophen
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Borderline Personality Disorder focused on measuring borderline personality disorder, rejection, social pain

Eligibility Criteria

18 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • The Ohio State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Acetaminophen 1000mg

Acetaminophen 500mg

Arm Description

Acetaminophen 1000mg capsule orally three times a day

500mg Acetaminophen orally three times a day

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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).
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

Full Information

First Posted
April 7, 2014
Last Updated
October 10, 2022
Sponsor
Ohio State University
Collaborators
National Center for Advancing Translational Sciences (NCATS), National Center for Research Resources (NCRR)
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1. Study Identification

Unique Protocol Identification Number
NCT02108990
Brief Title
Acetaminophen and Social Processes
Official Title
Acetaminophen and Social Pain in Borderline Personality Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
June 30, 2014 (Actual)
Study Completion Date
June 30, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University
Collaborators
National Center for Advancing Translational Sciences (NCATS), National Center for Research Resources (NCRR)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Borderline Personality Disorder
Keywords
borderline personality disorder, rejection, social pain

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acetaminophen 1000mg
Arm Type
Experimental
Arm Description
Acetaminophen 1000mg capsule orally three times a day
Arm Title
Acetaminophen 500mg
Arm Type
Experimental
Arm Description
500mg Acetaminophen orally three times a day
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Other Intervention Name(s)
Tylenol
Primary Outcome Measure Information:
Title
Change from baseline in symptom reports on the PAI-BOR at week 6
Description
Symptom reports on the PAI-BOR.
Time Frame
Baseline, Week 6
Title
Change from baseline in symptom severity on the Zanarini Rating Scale for Borderline Personality Disorder
Description
Zanarini Rating Scale for Borderline Personality Disorder
Time Frame
Baseline, Week 6
Secondary Outcome Measure Information:
Title
Symptom Reports
Description
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).
Time Frame
Baseline, weeks, 1,2,3,4,5,6 and 8.
Title
Daily Diary
Description
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
Time Frame
Daily for week 0,1,2, and 3

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Baldwin M Way, Ph.D.
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jennifer S. Cheavens, Ph.D.
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20548058
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.
Results Reference
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Acetaminophen and Social Processes

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