An Assessment of Fentanyl Dose Requirements in Opioid-maintained Individuals (FEN001)

February 4, 2013 updated by: Prof Paul Rolan, University of Adelaide
This study seeks to determine the suitable doses of fentanyl with acceptable adverse effect and safety profile in opioid-dependent patients. The investigators anticipate that a well tolerated dose of fentanyl which produces demonstrable analgesia will be found and will be related to the patient's maintenance opioid dose.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Fentanyl is a synthetic opiate with a (clinical) potency of 50 to 100 times that of morphine. Because of its high lipid solubility, fentanyl has a rapid onset of action and a relatively short duration of action. Fentanyl is one of the most widely used agents in the synthetic opioids family. Being a pure agonist with no active metabolites, it is highly suitable for use in patients with opioid tolerance. It can be used outside of an intensive-care clinical environment.

Evidence-based guidelines for clinicians on which agents to use, what doses should be considered and whether treatment doses are related to the dose and the pharmacological properties of the maintenance opioid are lacking, but needed. This study seeks to determine the suitable doses of fentanyl required in opioid-tolerant patients, which are able to overcome the tolerance and hyperalgesia while maintaining an acceptable therapeutic index. The importance of this study is that it has the potential to improve acute pain management in the opioid-tolerant population.

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • South Australia
      • Adelaide, South Australia, Australia, 5000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female, aged 18 to 65.
  2. Maintained on any opioid with oral morphine equivalent daily dose (MEDD) of 60 mg and above.
  3. Have adequate intravenous access for drug infusion.
  4. Are currently abstaining from oral and intravenous recreational drug use.

Exclusion Criteria:

  1. Known positive for Hepatitis B, Hepatitis C or HIV
  2. Contraindication to cold pain testing e.g. cardiac or vascular disease especially Raynaud's phenomenon, blood pressure problems, diabetes, epilepsy and recent serious injury.
  3. Using medication which affects pupil size e.g. glaucoma
  4. Visual acuity poorer than 6 / 25 corrected (so that saccadic eye movements can be performed correctly.
  5. Patients with respiratory insufficiency and poor respiratory drive. The criteria will be a spirometry reading of less than 70% the predicted value and/or having resting oxygen saturation levels of less than 95% on air.
  6. Subject is pregnant and/or lactating.
  7. Chronic use of benzodiazepines which cannot be withheld for 5 half-lives of the benzodiazepine the patient is on.
  8. Known intolerance to fentanyl or other opioids
  9. Patients taking tramadol.
  10. Patients taking CYP3A4 inhibitors like amiodarone, azole antifungals, cimetidine, clarithromycin, cyclosporine, diltiazem, erythromycin, fluoroquinolones, grapefruit juice, HIV protease inhibitors, metronidazole, quinine, selective serotonin reuptake inhibitors (SSRIs) and tacrolimus.
  11. A positive urine test for benzodiazepines on the day of screening or testing.
  12. A positive breathalyzer test on the day of testing.
  13. Creatinine clearance < 30ml/min as estimated by Cockcroft-Gault formula.
  14. Patients with bradyarrythmia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fentanyl
Drug: Fentanyl
Intravenous infusion using STANPUMP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Attainment of analgesia
Time Frame: Within 2 hours after starting the infusion
Attainment of analgesia as evidenced by having the cold pain tolerance test reading to twice the baseline value or reaching the absolute value of 2 minutes.
Within 2 hours after starting the infusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pupillometry
Time Frame: Within 2 hours after infusion starts
The pupil diameter will be measured every 30 minutes during the infusion.
Within 2 hours after infusion starts
Saccadic eye movement
Time Frame: Within 2 hours after infusion starts
The average peak velocity of the saccadic eye movement will be measured every half an hour for 2 hours.
Within 2 hours after infusion starts
Morphine Benzedrine Group Scale
Time Frame: Within 2 hours after infusion starts
This paper test will take 3 minutes to complete and will measure the degree of euphoria.
Within 2 hours after infusion starts
Electroencephalography (EEG)
Time Frame: Within 2 hours after infusion starts
The delta, theta and alpha Fz-Cz and Pz-Oz activity will be measured every 30 minutes during the infusion.
Within 2 hours after infusion starts
Subjective Opioid Withdrawal Scale
Time Frame: Within 1 hour after infusion stops
This paper test will take 3 minutes to complete and will measure the degree of withdrawal. It will be done at 15, 30 and 60 minutes post infusion.
Within 1 hour after infusion stops

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Adelaide

Investigators

  • Principal Investigator: Paul E Rolan, MD, University of Adelaide

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Anticipated)

March 1, 2013

Study Completion (Anticipated)

May 1, 2013

Study Registration Dates

First Submitted

May 20, 2011

First Submitted That Met QC Criteria

May 20, 2011

First Posted (Estimate)

May 23, 2011

Study Record Updates

Last Update Posted (Estimate)

February 6, 2013

Last Update Submitted That Met QC Criteria

February 4, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FEN001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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