NCT01358500

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 23, 2011

Completed
8 months until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

February 6, 2013

Status Verified

February 1, 2013

Enrollment Period

1.1 years

First QC Date

May 20, 2011

Last Update Submit

February 4, 2013

Conditions

Opioid Dependence

Keywords

opioid dependencetolerantdependent

Outcome Measures

Primary Outcomes (1)

  • 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.

    Within 2 hours after starting the infusion

Secondary Outcomes (5)

  • Pupillometry

    Within 2 hours after infusion starts

  • Saccadic eye movement

    Within 2 hours after infusion starts

  • Morphine Benzedrine Group Scale

    Within 2 hours after infusion starts

  • Electroencephalography (EEG)

    Within 2 hours after infusion starts

  • Subjective Opioid Withdrawal Scale

    Within 1 hour after infusion stops

Study Arms (1)

Fentanyl

EXPERIMENTAL
Drug: Fentanyl

Interventions

FentanylDRUG

Intravenous infusion using STANPUMP

Fentanyl

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PARC, Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

RECRUITING

Related Publications (2)

  • 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.

    PMID: 15907650BACKGROUND

  • 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.

    PMID: 15220793BACKGROUND

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Paul E Rolan, MD

    University of Adelaide

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul E Rolan

CONTACT

+61882222712

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 20, 2011

First Posted

May 23, 2011

Study Start

February 1, 2012

Primary Completion

March 1, 2013

Study Completion

May 1, 2013

Last Updated

February 6, 2013

Record last verified: 2013-02

Locations

AU(1)