An Assessment of Fentanyl Dose Requirements in Opioid-maintained Individuals

NCT ID: NCT01358500

Last Updated: 2013-02-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2013-05-31

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.

Conditions

Opioid Dependence

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fentanyl

Group Type: EXPERIMENTAL

Fentanyl

Intervention Type: DRUG

Intravenous infusion using STANPUMP

Interventions

Fentanyl

Intravenous infusion using STANPUMP

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Adelaide

OTHER

Sponsor Role: lead

Responsible Party

Prof Paul Rolan

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paul E Rolan, MD

Role: PRINCIPAL_INVESTIGATOR

University of Adelaide

Locations

PARC, Royal Adelaide Hospital

Adelaide, South Australia, Australia

Site Status: RECRUITING

Countries

Australia

Central Contacts

Paul E Rolan

Role: CONTACT

+61882222712

Facility Contacts

Rolan

Role: primary

paul.rolan@adelaide.edu.au

References

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.

Reference Type: BACKGROUND

PMID: 15907650 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15220793 (View on PubMed)

Other Identifiers

FEN001

Identifier Type: -

Identifier Source: org_study_id