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Completed

NCT Number: NCT02108990

Acetaminophen and Social Processes

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.

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Key information

Conditions

Borderline Personality Disorder Behavior Mental Disorders Personality Disorders Rejection, Psychology Social Behavior

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

The Ohio State University

Columbus, Ohio, 43210, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acetaminophen

Drug

Other names: Tylenol

Primary outcomes

  1. Change from baseline in symptom reports on the PAI-BOR at week 6

    Time frame: Baseline, Week 6

    Symptom reports on the PAI-BOR.

  2. Change from baseline in symptom severity on the Zanarini Rating Scale for Borderline Personality Disorder

    Time frame: Baseline, Week 6

    Zanarini Rating Scale for Borderline Personality Disorder

Secondary outcomes

  1. Symptom Reports

    Time frame: 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.

    • 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).

  2. Daily Diary

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)
  • National Center for Research Resources (NCRR)

Registry information

Official study title

Acetaminophen and Social Pain in Borderline Personality Disorder

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 9, 2014
Registry last updated
Jun 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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