Pilot Study on the Development of Opioid Induced Hyperalgesia (OIH) After Exposure to Alfentanil - Full Text View

Sponsor:	Johns Hopkins University
Information provided by:	Johns Hopkins University
ClinicalTrials.gov Identifier:	NCT00991809

Purpose

The purpose of this study is 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.

Condition	Intervention
Hyperalgesia	Drug: Alfentanil Drug: Diphenhydramine

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Pharmacokinetics/Dynamics Study
Official Title:	A Pilot Study of Prolonged, Intermittent Exposure to Alfentanil on Opioid-Induced Hyperalgesia in Healthy Volunteers

Resource links provided by NLM:

Drug Information available for: Promethazine hydrochloride Diphenhydramine Promethazine Alfentanil hydrochloride Alfentanil Diphenhydramine citrate Diphenhydramine hydrochloride

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:

change in pain tolerance (time to hand removal) in the cold pressor test [ Time Frame: 8 sessions over 4-6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in pain threshold (time to pain onset) of cold pressor testing [ Time Frame: 8 sessions over 4-6 weeks ] [ Designated as safety issue: No ]
analgesic effects (pain threshold and tolerance) on mechanical quantitative sensory testing [ Time Frame: 8 sessions over 4-6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	12
Study Start Date:	February 2009
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Alfentanil: Experimental These subjects will receive a series of acute alfentanil administrations each session (15 mcg/kg IM per session), with sessions spaced at 3-4 day intervals.	Drug: Alfentanil 15 mcg/kg IM
Diphenhydramine: Active Comparator Subjects will receive a series of acute diphenhydramine administrations each session (25 mg IM per session), with sessions spaced at 3-4 day intervals.	Drug: Diphenhydramine 25 mg IM

Detailed Description:

This project investigates the phenomenon of opioid-induced hyperalgesia (OIH). Opioid analgesics, in addition to their therapeutic anti-nociceptive effects, under some conditions produce pro-nociceptive effects. This phenomenon of pain or pain sensitivity being increased by prior opioid administration is called opioid-induced hyperalgesia. It is thought to be relevant both to pain management complications and to complications of opioid dependence and its treatment. This study investigates the time-course of opioid-induced hyperalgesia development in healthy normal volunteers (N=12 completers), using a series of acute alfentanil administrations (15 mg/kg mg IM per day) spaced at 3-4 day intervals, with testing for pain tolerance using the cold pressor test (CPT), and mechanical quantitative sensory testing (MQST) each administered repeatedly over time within each testing day. The goal is to determine the time course of OIH development following acute opioid administration, and to assess whether this changes over repeated acute opioid administrations.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00991809

Contacts

Contact: Sonia Bansal, BS

410-550-0009

sbansal4@jhmi.edu

Locations

United States, Maryland
Behavioral Pharmacology Research Unit	Recruiting
Baltimore, Maryland, United States, 21224
Principal Investigator: David A Tompkins, M.D.

Sponsors and Collaborators

Johns Hopkins University

Investigators

Principal Investigator:

David A Tompkins, M.D.

Johns Hopkins University

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Johns Hopkins University SOM ( D. Andrew Tompkins, MD )
Study ID Numbers:	0813, NIDA 1K24DA023186
Study First Received:	October 7, 2009
Last Updated:	October 7, 2009
ClinicalTrials.gov Identifier:	NCT00991809 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Johns Hopkins University:

opioid induced hyperalgesia

Additional relevant MeSH terms:

Sensation Disorders
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anesthetics
Antiemetics
Signs and Symptoms
Somatosensory Disorders
Promethazine
Sensory System Agents
Therapeutic Uses
Hypnotics and Sedatives
Antipruritics
Analgesics
Dermatologic Agents

Analgesics, Opioid
Anesthetics, Intravenous
Nervous System Diseases
Gastrointestinal Agents
Histamine Agents
Central Nervous System Depressants
Narcotics
Alfentanil
Anti-Allergic Agents
Hyperalgesia
Anesthetics, Local
Pharmacologic Actions
Histamine Antagonists
Anesthetics, General
Autonomic Agents

ClinicalTrials.gov processed this record on February 08, 2010