Inappropriate Dose of Drug AdministeredTAPERINGNCT03400384
Trial Applying Policy to Eliminate or Reduce Inappropriate Narcotics in the General-population
A study testing Direct-to-consumer educational brochure in people with Inappropriate Dose of Drug Administered and Pain, Chronic, run by Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal at 1 site in Canada.
Trial summary
To assess the effectiveness of a government-led population-based opioid intervention on discontinuation of opioid medication in community-dwelling adults with chronic non-cancer pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inappropriate Dose of Drug Administered, Pain, Chronic, Health Behavior
- What is being tested?
- Direct-to-consumer educational brochure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,255 participants
- Where
- 1 siteCanada
- Study dates
- 17 Jul 2018to 31 Dec 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults registered to receive pharmaceutical benefits in Manitoba, who are aged 18 years and over and who have received ≥90 days supply of opioids in the 6 months prior to the trial will be included. This will ensure chronic use and episodic use of opioids will be included.
Who cannot join
- People receiving palliative care, people with cancer, and people who receive opioids in hospital. People with dementia (identified by having received a prescription for memantine or a cholinersterase inhibitor in the previous 12 months) will be excluded.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institut universitaire de gériatrie de Montréal
Montreal, Quebec, H3W1W5
About this study
Official title: Using Policy to Reduce Opioids by Educating and Empowering Patients With Chronic Non-cancer Pain: The TAPERING Randomised Trial.
To assess the effectiveness of a government-led population-based opioid intervention on discontinuation of opioid medication in community-dwelling adults with chronic non-cancer pain.
- Being tested
- Direct-to-consumer educational brochure
- Keywords
- Deprescribing
- Medical subject headings
- Chronic Pain, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct-to-consumer educational brochureOther
The intervention arm will be mailed an evidence-based, theory-driven direct-to-consumer educational brochure, highlighting the potential benefits and harms of opioids when used to treat chronic non-cancer pain.
| Study group | Role | What they receive |
|---|---|---|
| Direct-to-consumer educational brochure | Experimental | The intervention arm will be mailed an evidence-based, theory-driven direct-to-consumer educational brochure, highlighting the potential benefits and harms of opioids when used to treat chronic non-cancer pain. Receives: Other: Direct-to-consumer educational brochure |
| Control wait list | No intervention | This arm will receive the intervention at the completion of the six-month follow-up period for the intervention group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete cessation of opioids
Provincial prescription insurance claims will be used to measure whether or not opioids are dispensed to community-dwelling adults randomized to either the intervention or control groups between baseline and 6-month follow up. Prescription data contain information on all dispensed prescriptions including drug name, dispensing date, dosage, drug form, the quantity of the drug dispensed, and the license number of the physician who wrote the prescription. Discontinuation of an opioid will be defined as the lack of a prescription claim for at least 60 days.
Measured: 6 months
Secondary outcomes (2)
Dose reduction or therapeutic switch to an alternate analgesic
The magnitude and direction of dose changes will be assessed for people who do not achieve the primary endpoint of complete cessation. New pharmacy dispensing of a prescription for a lower strength, or supply of a reduced quantity of tablets/patches will be considered in the dose reduction calculation. Where substitution to an alternative opioid occurs, opioid doses will be converted to "oral morphine equivalents" to determine the magnitude and direction of the change. A therapeutic switch will be indicated by a new dispensing for an alternative medication class.
Measured: 6 months
The proportion of people achieving opioid doses below 90mg oral morphine equivalents.
All opioids will be converted to an oral morphine equivalent dose. The proportion of patients who are prescribed <90mg of oral morphine equivalent at the end of the 6-month follow up will be compared to baseline.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start17 Jul 2018
- Primary completion30 Apr 2019
- Study completion31 Dec 2019
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 Inappropriate Dose of Drug AdministeredStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 4,255 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Cara Tannenbaum, Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
- Investigators
- Cara Tannenbaum, MD, MSc, Principal investigator, Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03400384
- Sponsor's protocol ID
- CIHR 201506PHSI-337814-MB
- Acronym
- TAPERING
- Status last verified
- Sep 2020
- First submitted
- 9 Jan 2018
- Last updated
- 29 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Turner JP, Halme AS, Caetano P, Langford A, Tannenbaum C. Government Direct-to-Consumer Education to Reduce Prescription Opioid Use: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2024 May 1;7(5):e2413698. doi: 10.1001/jamanetworkopen.2024.13698.
PubMed 38809554Turner JP, Caetano P, Tannenbaum C. Leveraging policy to reduce chronic opioid use by educating and empowering community dwelling adults: a study protocol for the TAPERING randomized controlled trial. Trials. 2019 Jul 9;20(1):412. doi: 10.1186/s13063-019-3508-z.
PubMed 31288859
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Policy to Reduce Opioids by Educating and Empowering Patients With Chronic Non-cancer Pain: The TAPERING Randomised Trial.
- ClinicalTrials.gov ID
- NCT03400384
- Acronym / sponsor ID
- TAPERING / CIHR 201506PHSI-337814-MB
- Keywords
- Deprescribing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,255 participants (actual)
- Lead sponsor
- Centre de Recherche de l'Institut Universitaire de Geriatrie de MontrealUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 17 Jul 2018 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 17 Jan 2018 (actual)
- 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.
To assess the effectiveness of a government-led population-based opioid intervention on discontinuation of opioid medication in community-dwelling adults with chronic non-cancer pain.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Direct-to-consumer educational brochure | Experimental | Other: Direct-to-consumer educational brochureThe intervention arm will be mailed an evidence-based, theory-driven direct-to-consumer educational brochure, highlighting the potential benefits and harms of opioids when used to treat chronic non-cancer pain. |
| Control wait list | No intervention | –This arm will receive the intervention at the completion of the six-month follow-up period for the intervention group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults registered to receive pharmaceutical benefits in Manitoba, who are aged 18 years and over and who have received ≥90 days supply of opioids in the 6 months prior to the trial will be included. This will ensure chronic use and episodic use of opioids will be included.
Key exclusion criteria (1 listed)
- People receiving palliative care, people with cancer, and people who receive opioids in hospital. People with dementia (identified by having received a prescription for memantine or a cholinersterase inhibitor in the previous 12 months) will be excluded.
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 |
|---|---|---|
| Direct-to-consumer educational brochureThe intervention arm will be mailed an evidence-based, theory-driven direct-to-consumer educational brochure, highlighting the potential benefits and harms of opioids when used to treat chronic non-cancer pain. | Other | Direct-to-consumer educational brochure |
Primary outcome
Complete cessation of opioids
Time frame: 6 months
Provincial prescription insurance claims will be used to measure whether or not opioids are dispensed to community-dwelling adults randomized to either the intervention or control groups between baseline and 6-month follow up. Prescription data contain information on all dispensed prescriptions including drug name, dispensing date, dosage, drug form, the quantity of the drug dispensed, and the license number of the physician who wrote the prescription. Discontinuation of an opioid will be defined as the lack of a prescription claim for at least 60 days.
2 secondary outcomes
Dose reduction or therapeutic switch to an alternate analgesic
Time frame: 6 months
The proportion of people achieving opioid doses below 90mg oral morphine equivalents.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2020.
- Derived from this study: PubMed 38809554Turner JP, Halme AS, Caetano P, Langford A, Tannenbaum C. Government Direct-to-Consumer Education to Reduce Prescription Opioid Use: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2024 May 1;7(5):e2413698. doi: 10.1001/jamanetworkopen.2024.13698.
- Derived from this study: PubMed 31288859Turner JP, Caetano P, Tannenbaum C. Leveraging policy to reduce chronic opioid use by educating and empowering community dwelling adults: a study protocol for the TAPERING randomized controlled trial. Trials. 2019 Jul 9;20(1):412. doi: 10.1186/s13063-019-3508-z.
- Individual participant dataSharing planned: Undecided
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.
Cara Tannenbaum, MD, MSc principal investigator
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Direct-to-consumer educational brochure in people with Inappropriate Dose of Drug Administered and Pain, Chronic, run by Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 29 Sep 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Complete cessation of opioids (time frame: 6 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 NCT03400384, 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 29 Sep 2020; AzTrials last refreshed its copy on 4 Nov 2026.