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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University of Adelaide
Sponsor:
Information provided by (Responsible Party):
Prof Paul Rolan, University of Adelaide
ClinicalTrials.gov Identifier:
NCT01358500
First received: May 20, 2011
Last updated: February 4, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Opioid Dependence
Drug: Fentanyl

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Assessment of Fentanyl Dose Requirements in Opioid-maintained Individuals

Resource links provided by NLM:


Further study details as provided by University of Adelaide:

Primary Outcome Measures:
  • Attainment of analgesia [ Time Frame: Within 2 hours after starting the infusion ] [ Designated as safety issue: No ]
    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 [ Time Frame: Within 2 hours after infusion starts ] [ Designated as safety issue: Yes ]
    The pupil diameter will be measured every 30 minutes during the infusion.

  • Saccadic eye movement [ Time Frame: Within 2 hours after infusion starts ] [ Designated as safety issue: No ]
    The average peak velocity of the saccadic eye movement will be measured every half an hour for 2 hours.

  • Morphine Benzedrine Group Scale [ Time Frame: Within 2 hours after infusion starts ] [ Designated as safety issue: Yes ]
    This paper test will take 3 minutes to complete and will measure the degree of euphoria.

  • Electroencephalography (EEG) [ Time Frame: Within 2 hours after infusion starts ] [ Designated as safety issue: No ]
    The delta, theta and alpha Fz-Cz and Pz-Oz activity will be measured every 30 minutes during the infusion.

  • Subjective Opioid Withdrawal Scale [ Time Frame: Within 1 hour after infusion stops ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 24
Study Start Date: February 2012
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fentanyl Drug: Fentanyl
Intravenous infusion using STANPUMP

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01358500

Contacts
Contact: Paul E Rolan +61882222712

Locations
Australia, South Australia
PARC, Royal Adelaide Hospital Recruiting
Adelaide, South Australia, Australia, 5000
Contact: Rolan       paul.rolan@adelaide.edu.au   
Principal Investigator: Paul E Rolan         
Sponsors and Collaborators
University of Adelaide
Investigators
Principal Investigator: Paul E Rolan, MD University of Adelaide
  More Information

Publications:
Responsible Party: Prof Paul Rolan, Professor, University of Adelaide
ClinicalTrials.gov Identifier: NCT01358500     History of Changes
Other Study ID Numbers: FEN001
Study First Received: May 20, 2011
Last Updated: February 4, 2013
Health Authority: Australia: National Health and Medical Research Council

Keywords provided by University of Adelaide:
opioid dependence
tolerant
dependent

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Fentanyl
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on August 27, 2014