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Acetaminophen and Social Processes

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Ohio State University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Baldwin Way, Ohio State University
ClinicalTrials.gov Identifier:
NCT02108990
First received: April 7, 2014
Last updated: NA
Last verified: April 2014
History: No changes posted
  Purpose

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 Intervention Phase
Borderline Personality Disorder
Drug: Acetaminophen
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Acetaminophen and Social Pain in Borderline Personality Disorder

Resource links provided by NLM:


Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • Change from baseline in symptom reports on the PAI-BOR at week 6 [ Time Frame: Baseline, Week 6 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Zanarini Rating Scale for Borderline Personality Disorder


Secondary Outcome Measures:
  • Symptom Reports [ Time Frame: Baseline, weeks, 1,2,3,4,5,6 and 8. ] [ Designated as safety issue: No ]

    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 Diary [ Time Frame: Daily for week 0,1,2, and 3 ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 30
Study Start Date: September 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acetaminophen 1000mg
Acetaminophen 1000mg capsule orally three times a day
Drug: Acetaminophen
Other Name: Tylenol
Experimental: Acetaminophen 500mg
500mg Acetaminophen orally three times a day
Drug: Acetaminophen
Other Name: Tylenol

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02108990

Contacts
Contact: Sophie Lazarus, M.A. 614-212-9775 lazarus.15@osu.edu

Locations
United States, Ohio
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Sophie Lazarus, M.A.    614-292-9775    lazarus.15@osu.edu   
Principal Investigator: Baldwin M Way, Ph.D.         
Principal Investigator: Jennifer S Cheavens, Ph.D.,         
Sponsors and Collaborators
Ohio State University
Investigators
Principal Investigator: Baldwin M Way, Ph.D. Ohio State University
Principal Investigator: Jennifer S. Cheavens, Ph.D. Ohio State University
  More Information

Publications:
Responsible Party: Baldwin Way, Assistant Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT02108990     History of Changes
Other Study ID Numbers: 2012HO294, KL2 RR 025754-04
Study First Received: April 7, 2014
Last Updated: April 7, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Ohio State University:
borderline personality disorder
rejection
social pain

Additional relevant MeSH terms:
Personality Disorders
Borderline Personality Disorder
Mental Disorders
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antipyretics

ClinicalTrials.gov processed this record on August 20, 2014