NCT01493908

Brief Summary

The efficacy of the placebo effect has been proved in many prior studies by comparing the symptoms and measures of patients. Placebo has been proved to help in treating illnesses such as depression, stomach ulcer and chronic headaches. A Meta analysis checked 47 studies about placebo and showed great significance when a patient is treated with placebo pill, no active substance, just by activating conditioning and expectation mechanism in his body, thus providing to the healing process, and that is it's importance. In recent years studies established a relationship between marketing variables (such as price, label) to the efficacy of a product. In addition- a unique research run in 2008 showed a significant relationship between the marketing strategies and the efficacy of medication; more specifically, patients in this research experienced less (controlled) pain when treated with placebo medication introduced to them as more expensive than patients treated with placebo medication that was introduced to them as much cheaper. All patients were treated with the exact same medication. In the investigator's experiment the investigators design a laboratory experiment to determine if marketing factors could invoke the placebo effects described earlier. For the initial laboratory experiment, we decided to examine the difference in price, on the efficacy of an OTC analgesic through the mediation of low- voltage electrical pulses to the patient's wrist. The investigators study hypothesis is that marketing variables such as price and brand name will affect the therapeutic efficacy of an analgesic, i.e. a medicine will have greater influence when the patient is aware of its price compared to one who is not.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
220

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable pain

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

December 15, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 16, 2011

Completed
16 days until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

December 16, 2011

Status Verified

December 1, 2011

Enrollment Period

11 months

First QC Date

December 15, 2011

Last Update Submit

December 15, 2011

Conditions

Keywords

Placebo effect;Pain; Analgesic;Electrical shockcontrol in healthy volunteers

Outcome Measures

Primary Outcomes (1)

  • pain thresholds

    Participants will rank their pain thresholds individually and subjectively for a series of pulses. Each participant will experience a series of pulses with random intensity. Pulse intensity will range within 30-90% of the participants maximal level.

    1hour

Study Arms (5)

High price

ACTIVE COMPARATOR
Drug: High price

Low price

ACTIVE COMPARATOR
Drug: Low price

Low price participants aware paying part

ACTIVE COMPARATOR
Drug: Low price participants aware paying part

No price

ACTIVE COMPARATOR
Drug: No price

Free of charge

ACTIVE COMPARATOR
Drug: Free of charge

Interventions

Acetaminophen label as high price

High price

Acetaminophen label as low price

Low price

Acetaminophen label as low price; participants aware they are paying part of the full price

Low price participants aware paying part

acetaminophen. No price - price issue not introduced to participants.

No price

Acetaminophen. participants aware the product is free of charge

Free of charge

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy Volunteer participants will be between the ages of 18 and 65

You may not qualify if:

  • Candidates who have had a history of cardiac problems, epilepsy, diabetes, or are pregnant will be excluded.
  • Taking no pain medication at the time of the experiment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Family Medicine, Hebrew University, JerusaelmIsrael

Jerusalem, 91120, Israel

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Amnon - Lahad, MD, MPH

    Hebrew University, Jerusalem Israel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amnon - Lahad, MD, MPH

CONTACT

Hadas - Lemberg, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2011

First Posted

December 16, 2011

Study Start

January 1, 2012

Primary Completion

December 1, 2012

Study Completion

June 1, 2013

Last Updated

December 16, 2011

Record last verified: 2011-12

Locations