Emotional PainNCT00561288
Effects of Acetaminophen on Hurt Feelings
A study testing acetaminophen and cornstarch in people with Emotional Pain, run by University of Toronto at 1 site in Canada.
Trial summary
The purpose of the study is to investigate whether ingestion of acetaminophen reduces the experience of hurt feelings. Read more about this study
- Who is it for?
- Ages 17 years and olderHealthy volunteers can take part
- Conditions the study is for
- Emotional Pain
- What is being tested?
- acetaminophen and cornstarch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2007to May 2008
- Phase
- Interventional
- 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 17 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- University of Toronto undergraduate psychology student
Who cannot join
- Alcohol consumption (more than 2 drinks per day)
- Intake of enzyme-inducing drugs
- Prolonged fasting/eating disorders/gastroenteritis
- Intake of other over-the-counter or prescription analgesics
- Liver Disorders
- History of abuse treatment
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to investigate whether ingestion of acetaminophen reduces the experience of hurt feelings.
- Conditions
- Emotional Pain
- Being tested
- acetaminophen, cornstarch
- Keywords
- Acetaminophen, Social Psychology, Affect, Interpersonal Rejection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acetaminophenDrug
2 x 1000 mg doses per day
cornstarchOther
2 x 1000 mg cornstarch per day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 2000 mg acetaminophen per day Receives: Drug: acetaminophen |
| 2 | Placebo comparator | 2000 mg cornstarch per day Receives: Other: cornstarch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported daily hurt feelings
Measured: 21 days
Secondary outcomes (2)
Reports of emotional states other than hurt feelings
Measured: 21 days
Evaluations of self-worth
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotional PainStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Investigators
- Geoff MacDonald, Ph.D., Principal investigator, University of TorontoNathan DeWall, Ph.D., Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00561288
- Sponsor's protocol ID
- 20619
- Status last verified
- Jun 2008
- First submitted
- 16 Nov 2007
- Last updated
- 25 Jun 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Acetaminophen on Hurt Feelings
- ClinicalTrials.gov ID
- NCT00561288
- Acronym / sponsor ID
- 20619
- Conditions
- Emotional Pain
- Keywords
- Acetaminophen, Social Psychology, Affect, Interpersonal Rejection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 20 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to investigate whether ingestion of acetaminophen reduces the experience of hurt feelings.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: acetaminophen2000 mg acetaminophen per day |
| 2 | Placebo comparator | Other: cornstarch2000 mg cornstarch per day |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- University of Toronto undergraduate psychology student
Key exclusion criteria (6 listed)
- Alcohol consumption (more than 2 drinks per day)
- Intake of enzyme-inducing drugs
- Prolonged fasting/eating disorders/gastroenteritis
- Intake of other over-the-counter or prescription analgesics
- Liver Disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acetaminophen2 x 1000 mg doses per day | Drug | 1 |
| cornstarch2 x 1000 mg cornstarch per day | Other | 2 |
Primary outcome
Self-reported daily hurt feelings
Time frame: 21 days
2 secondary outcomes
Reports of emotional states other than hurt feelings
Time frame: 21 days
Evaluations of self-worth
Time frame: 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geoff MacDonald, Ph.D. principal investigator
University of Toronto
Nathan DeWall, Ph.D. principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acetaminophen and cornstarch in people with Emotional Pain, run by University of Toronto at 1 site in Canada.
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 1 inclusion and 6 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 25 Jun 2008. 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 Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Self-reported daily hurt feelings (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jun 2008.