NCT00561288

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2007

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

November 16, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 20, 2007

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

June 25, 2008

Status Verified

June 1, 2008

Enrollment Period

6 months

First QC Date

November 16, 2007

Last Update Submit

June 23, 2008

Conditions

Emotional Pain

Keywords

AcetaminophenSocial PsychologyAffectInterpersonal Rejection

Outcome Measures

Primary Outcomes (1)

  • Self-reported daily hurt feelings

    21 days

Secondary Outcomes (2)

  • Reports of emotional states other than hurt feelings

    21 days

  • Evaluations of self-worth

    21 days

Study Arms (2)

1

EXPERIMENTAL

2000 mg acetaminophen per day

Drug: acetaminophen

2

PLACEBO COMPARATOR

2000 mg cornstarch per day

Other: cornstarch

Interventions

acetaminophenDRUG

2 x 1000 mg doses per day

1
cornstarchOTHER

2 x 1000 mg cornstarch per day

2

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • University of Toronto undergraduate psychology student

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Toronto

Toronto, Ontario, M5S 3G3, Canada

Location

MeSH Terms

Interventions

AcetaminophenStarch

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesGlucansBiopolymersPolymersMacromolecular SubstancesDietary CarbohydratesCarbohydratesPolysaccharides

Study Officials

  • Geoff MacDonald, Ph.D.

    University of Toronto

    PRINCIPAL INVESTIGATOR

  • Nathan DeWall, Ph.D.

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 16, 2007

First Posted

November 20, 2007

Study Start

November 1, 2007

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

June 25, 2008

Record last verified: 2008-06

Locations

CA(1)