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Borderline Personality DisorderPhase 2NCT02108990

Acetaminophen and Social Processes

A Phase 2 study testing Acetaminophen in people with Borderline Personality Disorder, run by Ohio State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 years, women only
Conditions the study is for
Borderline Personality Disorder
What is being tested?
Acetaminophen
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteUnited States
Study dates
Sep 2013to 30 Jun 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • clinical diagnosis of borderline personality disorder
  • 18 years or older
  • if on psychiatric medication, must be on a stable dose
  • able to swallow tablets

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The Ohio State University

    Columbus, Ohio, 43210

Other trials in United States

About this study

Official title: Acetaminophen and Social Pain in Borderline Personality Disorder

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.

Read more

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.

Being tested
Acetaminophen
Keywords
borderline personality disorder, rejection, social pain
Medical subject headings
Borderline Personality Disorder, Rejection, Psychology

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02108990
Study groupRoleWhat they receive
Acetaminophen 1000mgExperimentalAcetaminophen 1000mg capsule orally three times a day
Receives: Drug: Acetaminophen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in symptom reports on the PAI-BOR at week 6

    Symptom reports on the PAI-BOR.

    Measured: Baseline, Week 6

  2. Change from baseline in symptom severity on the Zanarini Rating Scale for Borderline Personality Disorder

    Zanarini Rating Scale for Borderline Personality Disorder

    Measured: Baseline, Week 6

Secondary outcomes (2)

  1. Symptom Reports

    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).

    Measured: Baseline, weeks, 1,2,3,4,5,6 and 8.

  2. Daily Diary

    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

    Measured: Daily for week 0,1,2, and 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2014 (estimated)
  2. Study startSep 2013
  3. Primary completion30 Jun 2014
  4. Study completion30 Jun 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02108990
Sponsor's protocol ID
2012HO294
Other IDs
KL2RR025754-04
Status last verified
May 2024
First submitted
7 Apr 2014
Last updated
4 Jun 2024
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 20548058

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Acetaminophen in people with Borderline Personality Disorder, run by Ohio State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in symptom reports on the PAI-BOR at week 6 (time frame: Baseline, Week 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02108990, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.

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