Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01358500




Registration number
NCT01358500
Ethics application status
Date submitted
20/05/2011
Date registered
23/05/2011
Date last updated
6/02/2013

Titles & IDs
Public title
An Assessment of Fentanyl Dose Requirements in Opioid-maintained Individuals
Scientific title
An Assessment of Fentanyl Dose Requirements in Opioid-maintained Individuals
Secondary ID [1] 0 0
FEN001
Universal Trial Number (UTN)
Trial acronym
FEN001
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Opioid Dependence 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Fentanyl

Experimental: Fentanyl -


Treatment: Drugs: Fentanyl
Intravenous infusion using STANPUMP
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Attainment of analgesia
Timepoint [1] 0 0
Within 2 hours after starting the infusion
Secondary outcome [1] 0 0
Pupillometry
Timepoint [1] 0 0
Within 2 hours after infusion starts
Secondary outcome [2] 0 0
Saccadic eye movement
Timepoint [2] 0 0
Within 2 hours after infusion starts
Secondary outcome [3] 0 0
Morphine Benzedrine Group Scale
Timepoint [3] 0 0
Within 2 hours after infusion starts
Secondary outcome [4] 0 0
Electroencephalography (EEG)
Timepoint [4] 0 0
Within 2 hours after infusion starts
Secondary outcome [5] 0 0
Subjective Opioid Withdrawal Scale
Timepoint [5] 0 0
Within 1 hour after infusion stops

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2013
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
PARC, Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Other
Name
University of Adelaide
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT01358500
Trial related presentations / publications
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Paul E Rolan, MD
Address 0 0
University of Adelaide
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Paul E Rolan
Address 0 0
Country 0 0
Phone 0 0
+61882222712
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01358500