NCT00991809

Brief Summary

The purpose of this study was to follow a person's response to experimental pain after multiple consecutive exposures to alfentanil or diphenhydramine to see if the person can tolerate the pain more, less, or the same at the end of the study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2009

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

February 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 7, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 8, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

October 14, 2013

Completed
Last Updated

October 6, 2017

Status Verified

September 1, 2017

Enrollment Period

1.2 years

First QC Date

October 7, 2009

Results QC Date

August 9, 2013

Last Update Submit

September 7, 2017

Conditions

Hyperalgesia

Keywords

opioid induced hyperalgesia

Outcome Measures

Primary Outcomes (1)

  • Pain Tolerance

    The participant places their hand in a water bath kept at 4 degrees Celsius (cold pressor test). They then continue to hold the hand in the water bath until they can no longer tolerate the pain (pain tolerance) or until the end of the testing (truncated at 300 seconds for safety purposes). Reported as the mean (time to hand removal in seconds) at the 30 minute time point.

    8 sessions over 4-6 weeks

Secondary Outcomes (1)

  • Pain Threshold

    8 sessions over 4-6 weeks

Study Arms (2)

Alfentanil

EXPERIMENTAL

Subjects received a series of acute alfentanil administrations each session (15 mcg/kg IM per session), with sessions spaced at 3-4 day intervals.

Drug: Alfentanil

Diphenhydramine

ACTIVE COMPARATOR

Subjects received a series of acute diphenhydramine administrations each session (25 mg IM per session), with sessions spaced at 3-4 day intervals.

Drug: Diphenhydramine

Interventions

AlfentanilDRUG

15 mcg/kg IM

Alfentanil
DiphenhydramineDRUG

25 mg IM

Also known as: Benadryl
Diphenhydramine

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-55
  • No active medical conditions
  • BMI between 20-30
  • Able and willing to perform/tolerate pain procedures
  • Able to communicate in English

You may not qualify if:

  • Lifetime substance use disorder, except for alcohol abuse/dependence in remission
  • Use of opiates in last 3 months
  • Ongoing marijuana use
  • Acute or chronic pain
  • Neurologic or psychiatric condition known to influence cold pressor testing (peripheral neuropathy, major depression, or schizophrenia)
  • Current use of prescribed or over the counter pain medications
  • Previous adverse reaction to opiate medications or diphenhydramine
  • Use of tobacco or caffeine on study days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Behavioral Pharmacology Research Unit

Baltimore, Maryland, 21224, United States

Location

Related Publications (1)

  • Tompkins DA, Smith MT, Bigelow GE, Moaddel R, Venkata SL, Strain EC. The effect of repeated intramuscular alfentanil injections on experimental pain and abuse liability indices in healthy males. Clin J Pain. 2014 Jan;30(1):36-45. doi: 10.1097/AJP.0b013e3182851758.

    PMID: 23446076RESULT

MeSH Terms

Conditions

Hyperalgesia

Interventions

AlfentanilDiphenhydramine

Condition Hierarchy (Ancestors)

Somatosensory DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

FentanylPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsEthylaminesAminesOrganic ChemicalsBenzhydryl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Limitations and Caveats

The sample size was intentionally small as this was to be a preliminary proof-of-concept step in the development of a human OIH model.

Results Point of Contact

Title
Dr. D. Andrew Tompkins
Organization
Johns Hopkins University, School of Medicine
dtompki1@jhmi.edu
410-550-5953

Study Officials

  • David A Tompkins, M.D.

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2009

First Posted

October 8, 2009

Study Start

February 1, 2009

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

October 6, 2017

Results First Posted

October 14, 2013

Record last verified: 2017-09

Locations

US(1)