Effects of Acetaminophen on Hurt Feelings | NCT00561288

Studies
Effects of Acetaminophen on Hurt Feelings

NCT00561288

Sponsor

University of Toronto

Status

Completed

Last Update Posted

Jun 25, 2008Estimated

Enrollment

60Actual

Phase

Not Applicable

Conditions

Emotional Pain

Interventions

acetaminophen
cornstarch

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2007

Primary Completion Date

May 2008Actual

Completion Date

May 2008Actual

First Submitted Date

Nov 16, 2007

First Submission Date that Met QC Criteria

Nov 16, 2007

First Posted Date

Nov 20, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 23, 2008

Last Update Posted Date

Jun 25, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of the study is to investigate whether ingestion of acetaminophen reduces the experience of hurt feelings.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	2000 mg acetaminophen per day	Drug: acetaminophen
2	Placebo Comparator	2000 mg cornstarch per day	Other: cornstarch

Interventions

Name	Type	Description	Arm Group Labels	Other Names
acetaminophen	Drug	2 x 1000 mg doses per day	1
cornstarch

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Self-reported daily hurt feelings		21 days

Secondary Outcomes

Measure	Description	Time Frame
Reports of emotional states other than hurt feelings		21 days
Evaluations of self-worth		21 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

University of Toronto undergraduate psychology student

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

17 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Geoff MacDonald, Ph.D.	University of Toronto	Principal Investigator
Nathan DeWall, Ph.D.	University of Kentucky	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Toronto		Toronto	Ontario	M5S 3G3	Canada

Intervention Browse Module

MeSH Terms

ID	Term
D000082	Acetaminophen
D013213	Starch

Ancestor Terms

ID	Term
D000083	Acetanilides
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814

Browse Leaves

Not provided

Browse Branches

Not provided