Acetaminophen and Social Processes

NCT ID: NCT02108990

Last Updated: 2024-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2014-06-30

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.

Conditions

Borderline Personality Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Acetaminophen 1000mg

Acetaminophen 1000mg capsule orally three times a day

Group Type: EXPERIMENTAL

Acetaminophen

Intervention Type: DRUG

Interventions

Acetaminophen

Intervention Type: DRUG

Other Intervention Names

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role: collaborator

National Center for Research Resources (NCRR)

NIH

Sponsor Role: collaborator

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Baldwin Way

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Baldwin M Way, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Jennifer S. Cheavens, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

The Ohio State University

Columbus, Ohio, United States

Countries

United States

References

Dewall CN, Macdonald G, Webster GD, Masten CL, Baumeister RF, Powell C, Combs D, Schurtz DR, Stillman TF, Tice DM, Eisenberger NI. Acetaminophen reduces social pain: behavioral and neural evidence. Psychol Sci. 2010 Jul;21(7):931-7. doi: 10.1177/0956797610374741. Epub 2010 Jun 14.

Reference Type: BACKGROUND

PMID: 20548058 (View on PubMed)

Other Identifiers

KL2RR025754-04

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2012HO294

Identifier Type: -

Identifier Source: org_study_id