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Acetaminophen and Social Processes

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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
Sponsor:
Collaborator:
National Center for Advancing Translational Science (NCATS)
Information provided by (Responsible Party):
Baldwin Way, 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.


Condition or disease Intervention/treatment Phase
Borderline Personality Disorder Drug: Acetaminophen Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Change from baseline in symptom reports on the PAI-BOR at week 6 [ Time Frame: Baseline, Week 6 ]
    Symptom reports on the PAI-BOR.

  2. 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


Secondary Outcome Measures :
  1. 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.

    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).


  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02108990


Locations
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
National Center for Advancing Translational Science (NCATS)
Investigators
Principal Investigator: Baldwin M Way, Ph.D. Ohio State University
Principal Investigator: Jennifer S. Cheavens, Ph.D. Ohio State University

Publications:
Responsible Party: Baldwin Way, Assistant Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT02108990     History of Changes
Other Study ID Numbers: 2012HO294
KL2RR025754-04 ( U.S. NIH Grant/Contract )
First Posted: April 9, 2014    Key Record Dates
Last Update Posted: December 22, 2015
Last Verified: December 2015

Keywords provided by Baldwin Way, 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
Antipyretics