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

Primary Purpose

Opioid Dependence

Status

Unknown status

Phase

Not Applicable

Locations

Australia

Study Type

Interventional

Intervention

Fentanyl

About this trial

This is an interventional treatment trial for Opioid Dependence focused on measuring opioid dependence, tolerant, dependent

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Known positive for Hepatitis B, Hepatitis C or HIV
Contraindication to cold pain testing e.g. cardiac or vascular disease especially Raynaud's phenomenon, blood pressure problems, diabetes, epilepsy and recent serious injury.
Using medication which affects pupil size e.g. glaucoma
Visual acuity poorer than 6 / 25 corrected (so that saccadic eye movements can be performed correctly.
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.
Subject is pregnant and/or lactating.
Chronic use of benzodiazepines which cannot be withheld for 5 half-lives of the benzodiazepine the patient is on.
Known intolerance to fentanyl or other opioids
Patients taking tramadol.
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.
A positive urine test for benzodiazepines on the day of screening or testing.
A positive breathalyzer test on the day of testing.
Creatinine clearance < 30ml/min as estimated by Cockcroft-Gault formula.
Patients with bradyarrythmia.

Sites / Locations

PARC, Royal Adelaide HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fentanyl

Arm Description

Outcomes

Primary Outcome Measures

Attainment of analgesia

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.

Secondary Outcome Measures

Pupillometry

The pupil diameter will be measured every 30 minutes during the infusion.

Saccadic eye movement

The average peak velocity of the saccadic eye movement will be measured every half an hour for 2 hours.

Morphine Benzedrine Group Scale

This paper test will take 3 minutes to complete and will measure the degree of euphoria.

Electroencephalography (EEG)

The delta, theta and alpha Fz-Cz and Pz-Oz activity will be measured every 30 minutes during the infusion.

Subjective Opioid Withdrawal Scale

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.

Full Information

NCT ID

NCT01358500

First Posted

May 20, 2011

Last Updated

February 4, 2013

Sponsor

University of Adelaide

1. Study Identification

Unique Protocol Identification Number

NCT01358500

Brief Title

An Assessment of Fentanyl Dose Requirements in Opioid-maintained Individuals

Acronym

FEN001

Official Title

An Assessment of Fentanyl Dose Requirements in Opioid-maintained Individuals

Study Type

Interventional

2. Study Status

Record Verification Date

February 2013

Overall Recruitment Status

Unknown status

Study Start Date

February 2012 (undefined)

Primary Completion Date

March 2013 (Anticipated)

Study Completion Date

May 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Adelaide

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Opioid Dependence

Keywords

opioid dependence, tolerant, dependent

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Fentanyl

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Fentanyl

Intervention Description

Intravenous infusion using STANPUMP

Primary Outcome Measure Information:

Title

Attainment of analgesia

Description

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.

Time Frame

Within 2 hours after starting the infusion

Secondary Outcome Measure Information:

Title

Pupillometry

Description

The pupil diameter will be measured every 30 minutes during the infusion.

Time Frame

Within 2 hours after infusion starts

Title

Saccadic eye movement

Description

The average peak velocity of the saccadic eye movement will be measured every half an hour for 2 hours.

Time Frame

Within 2 hours after infusion starts

Title

Morphine Benzedrine Group Scale

Description

This paper test will take 3 minutes to complete and will measure the degree of euphoria.

Time Frame

Within 2 hours after infusion starts

Title

Electroencephalography (EEG)

Description

The delta, theta and alpha Fz-Cz and Pz-Oz activity will be measured every 30 minutes during the infusion.

Time Frame

Within 2 hours after infusion starts

Title

Subjective Opioid Withdrawal Scale

Description

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.

Time Frame

Within 1 hour after infusion stops

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female, aged 18 to 65. Maintained on any opioid with oral morphine equivalent daily dose (MEDD) of 60 mg and above. Have adequate intravenous access for drug infusion. Are currently abstaining from oral and intravenous recreational drug use. Exclusion Criteria: Known positive for Hepatitis B, Hepatitis C or HIV Contraindication to cold pain testing e.g. cardiac or vascular disease especially Raynaud's phenomenon, blood pressure problems, diabetes, epilepsy and recent serious injury. Using medication which affects pupil size e.g. glaucoma Visual acuity poorer than 6 / 25 corrected (so that saccadic eye movements can be performed correctly. 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. Subject is pregnant and/or lactating. Chronic use of benzodiazepines which cannot be withheld for 5 half-lives of the benzodiazepine the patient is on. Known intolerance to fentanyl or other opioids Patients taking tramadol. 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. A positive urine test for benzodiazepines on the day of screening or testing. A positive breathalyzer test on the day of testing. Creatinine clearance < 30ml/min as estimated by Cockcroft-Gault formula. Patients with bradyarrythmia.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Paul E Rolan

Phone

+61882222712

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul E Rolan, MD

Organizational Affiliation

University of Adelaide

Official's Role

Principal Investigator

Facility Information:

Facility Name

PARC, Royal Adelaide Hospital

City

Adelaide

State/Province

South Australia

ZIP/Postal Code

5000

Country

Australia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rolan

paul.rolan@adelaide.edu.au

First Name & Middle Initial & Last Name & Degree

Paul E Rolan

12. IPD Sharing Statement

Citations:

PubMed Identifier

15907650

Citation

Lotsch J. Pharmacokinetic-pharmacodynamic modeling of opioids. J Pain Symptom Manage. 2005 May;29(5 Suppl):S90-103. doi: 10.1016/j.jpainsymman.2005.01.012.

Results Reference

background

PubMed Identifier

15220793

Citation

Mitra S, Sinatra RS. Perioperative management of acute pain in the opioid-dependent patient. Anesthesiology. 2004 Jul;101(1):212-27. doi: 10.1097/00000542-200407000-00032. No abstract available.

Results Reference

background

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An Assessment of Fentanyl Dose Requirements in Opioid-maintained Individuals

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