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Acetaminophen and Social Processes

Acetaminophen and Social Pain in Borderline Personality Disorder

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02108990
Enrollment
9
Registered
2014-04-09
Start date
2013-09-30
Completion date
2014-06-30
Last updated
2024-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Borderline Personality Disorder

Keywords

borderline personality disorder, rejection, social pain

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.

Interventions

DRUGAcetaminophen

Sponsors

National Center for Advancing Translational Sciences (NCATS)
CollaboratorNIH
National Center for Research Resources (NCRR)
CollaboratorNIH
Ohio State University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

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.

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Symptom ReportsBaseline, 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 DiaryDaily for week 0,1,2, and 3The 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026