Acetaminophen and Social Processes

Study Overview
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Brief Summary
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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.

Official Title
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Acetaminophen and Social Pain in Borderline Personality Disorder

Conditions
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Borderline Personality Disorder

Intervention / Treatment
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* Drug: Acetaminophen


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acetaminophen 1000mg<br>Acetaminophen 1000mg capsule orally three times a day | Drug: Acetaminophen<br> <br> * Other names: Tylenol;|
| Experimental: Acetaminophen 500mg<br>500mg Acetaminophen orally three times a day | Drug: Acetaminophen<br> <br> * Other names: Tylenol;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rejection, borderline personality disorder, social pain