Acetaminophen and Social Processes
|ClinicalTrials.gov Identifier: NCT02108990|
Recruitment Status : Unknown
Verified December 2015 by Baldwin Way, Ohio State University.
Recruitment status was: Active, not recruiting
First Posted : April 9, 2014
Last Update Posted : December 22, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Borderline Personality Disorder||Drug: Acetaminophen||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Acetaminophen and Social Pain in Borderline Personality Disorder|
|Study Start Date :||September 2013|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2017|
Experimental: Acetaminophen 1000mg
Acetaminophen 1000mg capsule orally three times a day
Other Name: Tylenol
Experimental: Acetaminophen 500mg
500mg Acetaminophen orally three times a day
Other Name: Tylenol
- Change from baseline in symptom reports on the PAI-BOR at week 6 [ Time Frame: Baseline, Week 6 ]Symptom reports on the PAI-BOR.
- 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
- 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).
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02108990
|United States, Ohio|
|The Ohio State University|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||Baldwin M Way, Ph.D.||Ohio State University|
|Principal Investigator:||Jennifer S. Cheavens, Ph.D.||Ohio State University|