Acetaminophen and Social Processes

Acetaminophen and Social Pain in Borderline Personality Disorder

Sponsors

Lead Sponsor: Ohio State University

Collaborator: National Center for Advancing Translational Science (NCATS)

Source Ohio State University
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.

Overall Status Unknown status
Start Date 2013-09-01
Completion Date 2017-12-01
Primary Completion Date 2016-12-01
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Change from baseline in symptom reports on the PAI-BOR at week 6 Baseline, Week 6
Change from baseline in symptom severity on the Zanarini Rating Scale for Borderline Personality Disorder Baseline, Week 6
Secondary Outcome
Measure Time Frame
Symptom Reports Baseline, weeks, 1,2,3,4,5,6 and 8.
Daily Diary Daily for week 0,1,2, and 3
Enrollment 30
Condition
Intervention

Intervention Type: Drug

Intervention Name: Acetaminophen

Other Name: Tylenol

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.

Gender:

Female

Minimum Age:

18 Years

Maximum Age:

50 Years

Healthy Volunteers:

No

Overall Official
Location
Facility: The Ohio State University
Location Countries

United States

Verification Date

2015-12-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Ohio State University

Investigator Full Name: Baldwin Way

Investigator Title: Assistant Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Acetaminophen 1000mg

Type: Experimental

Description: Acetaminophen 1000mg capsule orally three times a day

Label: Acetaminophen 500mg

Type: Experimental

Description: 500mg Acetaminophen orally three times a day

Study Design Info

Allocation: Non-Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Basic Science

Masking: None (Open Label)

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