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Chronic PainPhase 4NCT04132011

Dosing Intervals of Opioid Medication for Chronic Pain

A Phase 4 study testing Extended Release Opioid Formulation, Shortened Intervals and Extended Release Opioid Formulation, Standard intervals in people with Chronic Pain, run by University Health Network, Toronto at 1 site in Canada.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This study is to determine the feasibility of an n-of-1, randomized, double blind, placebo controlled case series to examine effects of extended release opioids when used at intervals shorter than recommended by the manufacturer by people with chronic pain. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Pain
What is being tested?
Extended Release Opioid Formulation, Shortened Intervals and Extended Release Opioid Formulation, Standard intervals
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
1 siteCanada
Study dates
1 May 2019to 8 Mar 2020
Phase
Phase 4
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • >18 years old
  • willing and capable to give written informed consent
  • diagnosis of chronic pain (> 3 months)
  • current prescription for oxycodone controlled release or hydromorphone controlled release or morphine sustained release for pain
  • Using extended release opioids at intervals less than 12 hours/ more than twice daily

Who cannot join

  • ongoing acute pain episode
  • use of immediate release opioids that contribute to more than 20% of their total daily opioid dose
  • total daily morphine equivalent dose >400mg
  • actively tapering their opioid dose
  • use of multiple extended release opioid products
  • unstable psychological diagnosis (using the Psychosocial Screening Interview Guide)
Show all 14Show fewer
  • outstanding or planned litigation related to pain
  • pregnancy or lactation in women
  • history of coronary artery disease
  • active tapering or titration of benzodiazepines or cannabinoids
  • positive urine drug screen for amphetamines, barbiturates, cocaine, methamphetamine, methadone, phencyclidine, propoxyphene or unexpected opioids or benzodiazepines
  • using M-Eslon
  • using long acting hydromorphone
  • using Kadian

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • University Health Network

    Toronto, Ontario, M5G 2A2

Other trials in Canada

About this study

Official title: Examining the Relationship Amongst Opioid Subjective Effects and Pharmacokinetics of Extended Release Opioids at Shortened Dosing Intervals in Patients With Chronic Pain: a Randomized, Blinded, N-of-1 Case Series Feasibility Study

This study is to determine the feasibility of an n-of-1, randomized, double blind, placebo controlled case series to examine effects of extended release opioids when used at intervals shorter than recommended by the manufacturer by people with chronic pain.

Conditions
Chronic Pain
Being tested
Extended Release Opioid Formulation, Shortened Intervals, Extended Release Opioid Formulation, Standard intervals, Placebo oral tablet
Keywords
opioid
Medical subject headings
Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Extended Release Opioid Formulation, Shortened IntervalsDrug

    Also called Hydromorphone extended release, HydromorphContin, Oxycodone controlled release, morphine sulphate sustained release

    Extended release opioid, individualized total daily dose, dosing interval is less than every 12 hours

  • Extended Release Opioid Formulation, Standard intervalsDrug

    Also called Hydromorphone extended release, HydromorphContin, Oxycodone controlled release, Morphine sulphate sustained release

    Extended release opioid, individualized total daily dose, dosing interval is every 12 hours

  • Placebo oral tabletDrug

    Also called Placebo (for Extended release opioid)

    Lactose pill manufactured to mimic extended release opioid formulation

Study groups in NCT04132011
Study groupRoleWhat they receive
Shortened interval extended release opioidActive comparatorExtended release opioid, individualized total daily dose, dosing intervals less than every 12 hours.
Receives: Drug: Extended Release Opioid Formulation, Shortened Intervals; Drug: Placebo oral tablet
Standard interval extended release opioidActive comparatorExtended release opioid, individualized total daily dose, dosing intervals every 12 hours
Receives: Drug: Extended Release Opioid Formulation, Standard intervals; Drug: Placebo oral tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of participants who complete both treatment periods and have evaluable Patient Global Impression and pharmacokinetic data

    Feasibility outcome

    Measured: 8 months

Secondary outcomes (12)

  1. Patient Global Impression of Change

    Single-item rating by subjects of their improvement with treatment on a 7-point scale that ranges from the lowest rating of 1= 'very much improved' to the highest rating of 7= 'very much worse'. Higher values are considered to be a better outcome.

    Measured: 3 weeks

  2. Numerical Pain Rating Scale

    A measure of pain intensity. Ten point scale with a minimum of "0"= no pain to a maximum of "10" = worst pain imaginable. Higher scores represent a worse outcome.

    Measured: 3 weeks

  3. Brief Pain Inventory (Short Form)

    An inventory of questions about pain, including a pain diagram, pain intensity rating subscales and pain interference rating subscales. The four pain intensity rating subscales are "pain at worst", "pain at least", "pain on average" and "pain right now". These are 10-point scales with a minimum of "0" =no pain, and a maximum of "10"= pain as bad as you can imagine", where higher scores are worse. Pain intensity subscales can be combined as an average on the same scale of 0-10. The eight pain interference subscales measuring interference on general activity, mood, walking ability, work, relations with other people, sleep, enjoyment of life, are 10-point subscales which range a minimum of "0" = pain does not interfere, to a maximum of "10"=pain completely interferes with the item. Higher scores are worse outcomes. Pain interference subscales may be combined as an total score out of 80, or divided by eight to get an average of pain interference on the scale of 0-10.

    Measured: 3 weeks

  4. Subjective Opioid Withdrawal Scale

    A self-administered scale for grading 16 opioid withdrawal symptoms on a scale of '0' meaning 'not at all' to '4' meaning 'extremely'. Higher numbers are worse outcomes.

    Measured: 3 weeks

  5. Addiction Research Centre Inventory (ARCI) - short form

    The short version of the ARCI is a well-validated, standardized, self-report questionnaire of 49 "true-false" items and is used to differentiate subjective effects of drugs. True = 1, False = 0, responses to selected items are added for scores on different scales. Three of the scales are pertinent to opioid abuse liability: MBG (morphine-benzedrine group), a measure of euphoria, minimum = 0, and a maximum = 16); PCAG (pentobarbital-chlorpromazine-alcohol group) a measure of sedation, minimum =0, maximum=15; LSD (lysergic acid diethylamide scale) a measure of dysphoric and psychotomimetic changes, minimum=0, maximum =14. Higher scores are worse outcomes.

    Measured: 8 hours

  6. Profile of Mood States

    A widely used, self-reported questionnaire for assessing drug-induced changes in mood. It has 72 adjectives and phrases describing feelings people have, and ask for the user to describe "how you are feeling right now" on a 5 point scale of descriptives: with a minimum value = 0 "Not at all", to a maximum value of 4= "extremely". Total mood disturbance is calculated by adding the results of the 6 subscales, and then subtracting the vigor -activity subscale (range 0-200). Subscales (six) are calculating by adding specific items: tension-anxiety (9 items, range 0-36), depression (15 items, range 0-60), anger-hostility (12 items, range 0-48), vigor-activity (8 items, range 0-32), fatigue (7 items, range 0-28), confusion-bewilderment (7 items, range 0-28).

    Measured: 8 hours

  7. Visual analogue scale - liking/high

    Visual analog scales are 100mm lines, anchored at the ends by opposing adjectives (e.g. like-dislike). "Like" is at the minimum, 0mm mark, "dislike" is at the maximum, 100mm mark. Subjects are instructed to rate how they feel along a continuum by making a mark along the line. The measurement of drug liking is considered to be one of the most sensitive and reliable assessments of the likelihood of abuse of a drug. "Liking" and "High" at the 100mm marks would be considered worse outcomes in terms of likelihood of abuse of a substance.

    Measured: 8 hours

  8. Serum opioid concentrations

    Serum opioid concentrations at 0,30 mins, 1,2,3,4,5,6 hours post-dose

    Measured: 6 hours

  9. Peak plasma concentration (Cmax)

    The maximum concentration achieved post dose

    Measured: 6 hours

  10. Time to peak plasma concentration (Tmax)

    Time that peak plasma concentration occurs post-dose

    Measured: 6 hours

  11. Area under the plasma concentration versus time curve (AUC)

    Calculated area under the plasma concentration versus time curve, which describes exposure to the drug.

    Measured: 24 hours

  12. Abuse liability quotient (AQ)

    The peak plasma concentration (Cmax) divided by the time to peak plasma concentration, which describes a calculation of the average rate of increase in plasma concentration over the interval between treatment administration and the time of peak plasma concentration.

    Measured: 6 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2019
  2. Study start1 May 2019
  3. Primary completion8 Mar 2020
  4. Study completion8 Mar 2020

Why it stopped: No recruitment (Feasibility study).

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
Feasibility study of an n-of-1, within-subject, crossover, randomized, double blind, placebo controlled case series
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04132011
Sponsor's protocol ID
17-6180
Status last verified
Sep 2019
First submitted
2 Oct 2019
Last updated
27 Mar 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Extended Release Opioid Formulation, Shortened Intervals and Extended Release Opioid Formulation, Standard intervals in people with Chronic Pain, run by University Health Network, Toronto at 1 site in Canada.

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 5 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: withdrawn, as of the sponsor's last update on 27 Mar 2020. 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 Canada. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of participants who complete both treatment periods and have evaluable Patient Global Impression and pharmacokinetic data (time frame: 8 months). 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 NCT04132011.

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 27 Mar 2020.

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