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Study on the Development of Opioid Induced Hyperalgesia (OIH) After Exposure to Alfentanil

NCT ID: NCT00991809

Last Updated: 2017-10-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2010-05-31

Brief Summary

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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.

Detailed Description

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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 investigated 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 intramuscular (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 was to determine the time course of OIH development following acute opioid administration, and to assess whether this changes over repeated acute opioid administrations.

Conditions

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Hyperalgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Alfentanil

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

Group Type EXPERIMENTAL

Alfentanil

Intervention Type DRUG

15 mcg/kg IM

Diphenhydramine

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

Group Type ACTIVE_COMPARATOR

Diphenhydramine

Intervention Type DRUG

25 mg IM

Interventions

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Alfentanil

15 mcg/kg IM

Intervention Type DRUG

Diphenhydramine

25 mg IM

Intervention Type DRUG

Other Intervention Names

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Benadryl

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David A Tompkins, M.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Behavioral Pharmacology Research Unit

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 23446076 (View on PubMed)

Other Identifiers

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1K24DA023186

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NA_00022154

Identifier Type: -

Identifier Source: org_study_id