Opioid DependenceFEN001NCT01358500
An Assessment of Fentanyl Dose Requirements in Opioid-maintained Individuals
A study testing Fentanyl in people with Opioid Dependence, run by University of Adelaide at 1 site in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Opioid Dependence
- What is being tested?
- Fentanyl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteAustralia
- Study dates
- Feb 2012to May 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Paul E Rolan contact
Australia1 site, 1 recruiting
- Recruiting
PARC, Royal Adelaide Hospital
Adelaide, South Australia, 5000
Rolan, paul.rolan@adelaide.edu.au
Paul E Rolan
About this study
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.
Read the 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
- Being tested
- Fentanyl
- Keywords
- opioid dependence, tolerant, dependent
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylDrug
Intravenous infusion using STANPUMP
| Study group | Role | What they receive |
|---|---|---|
| Fentanyl | Experimental | Not described Receives: Drug: Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 2 hours after starting the infusion
Secondary outcomes (5)
Pupillometry
The pupil diameter will be measured every 30 minutes during the infusion.
Measured: Within 2 hours after infusion starts
Saccadic eye movement
The average peak velocity of the saccadic eye movement will be measured every half an hour for 2 hours.
Measured: Within 2 hours after infusion starts
Morphine Benzedrine Group Scale
This paper test will take 3 minutes to complete and will measure the degree of euphoria.
Measured: Within 2 hours after infusion starts
Electroencephalography (EEG)
The delta, theta and alpha Fz-Cz and Pz-Oz activity will be measured every 30 minutes during the infusion.
Measured: Within 2 hours after infusion starts
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.
Measured: Within 1 hour after infusion stops
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2011 (estimated)
- Study startFeb 2012
- Primary completionMar 2013 (estimated)
- Study completionMay 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Opioid DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Adelaide
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Paul Rolan, University of Adelaide
- Investigators
- Paul E Rolan, MD, Principal investigator, University of Adelaide
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01358500
- Sponsor's protocol ID
- FEN001
- Acronym
- FEN001
- Status last verified
- Feb 2013
- First submitted
- 20 May 2011
- Last updated
- 6 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 15907650Mitra 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.
PubMed 15220793
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Assessment of Fentanyl Dose Requirements in Opioid-maintained Individuals
- ClinicalTrials.gov ID
- NCT01358500
- Acronym / sponsor ID
- FEN001 / FEN001
- Conditions
- Opioid Dependence
- Keywords
- opioid dependence, tolerant, dependent
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of AdelaideUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Mar 2013 (estimated)
- Study completion
- May 2013 (estimated)
- First posted
- 23 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fentanyl | Experimental | Drug: Fentanyl |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FentanylIntravenous infusion using STANPUMP | Drug | Fentanyl |
Primary outcome
Attainment of analgesia
Time frame: Within 2 hours after starting the infusion
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.
5 secondary outcomes
Pupillometry
Time frame: Within 2 hours after infusion starts
Saccadic eye movement
Time frame: Within 2 hours after infusion starts
Morphine Benzedrine Group Scale
Time frame: Within 2 hours after infusion starts
Electroencephalography (EEG)
Time frame: Within 2 hours after infusion starts
Subjective Opioid Withdrawal Scale
Time frame: Within 1 hour after infusion stops
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2013.
- Background: PubMed 15907650Lotsch 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.
- Background: PubMed 15220793Mitra 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul E Rolan contact
Paul E Rolan, MD principal investigator
University of Adelaide
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fentanyl in people with Opioid Dependence, run by University of Adelaide at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paul E Rolan (+61882222712), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attainment of analgesia (time frame: Within 2 hours after starting the infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01358500, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2013.