ClinicalTrials.gg
CompletedNCT03400384TAPERINGUpdated Sep 29, 2020

Trial Applying Policy to Eliminate or Reduce Inappropriate Narcotics in the General-population

An interventional study of Direct-to-consumer educational brochure in Inappropriate Dose of Drug Administered, Pain, Chronic and Health Behavior, sponsored by Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-29.

Sponsored by Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
4,255
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 202 studies in Chronic Pain with a site in Canada — 52 open to participants now, 63 under way, 3 of them phase 3. Chronic Pain · Canada.

Enrollment
Largest of 162
4,255 · median 49
Started
2018
with 17 others
No phase
116 of 202
31 open now
Registered
73rd of 202
by date

Among the 202 studies in Chronic Pain with a site in Canada, this one has the largest enrollment of the 162 interventional ones that give a count, is one of 18 that started in 2018, is one of 116 with no phase, and was the 73rd registered.

Chronic Pain

3,227 studies on the registry are indexed under Chronic Pain; 728 are open to participants now.

Browse Chronic Pain studies →

Open to participants now

52 of the 202 studies in Chronic Pain with a site in Canada are open now. Recruiting first, the newest first:

47 more — sign in →

All 52 open studies →

A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →

Who these studies take

Of the 486 Chronic Pain studies recruiting now, 239 (49%) set no upper age limit and 173 (36%) stop at 75 or younger; 43 take children under 18; 64 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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.

03

Conditions studied

  • Inappropriate Dose of Drug Administered
  • Pain, Chronic
  • Health Behavior

Keywords

  • Deprescribing
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
4,255 participants (actual)

Study arms

  • Experimental
    Direct-to-consumer educational brochure

    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.

    Other: Direct-to-consumer educational brochure

  • No intervention
    Control wait list

    This arm will receive the intervention at the completion of the six-month follow-up period for the intervention group.

Interventions

  • OtherDirect-to-consumer educational brochure

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6 months

Secondary outcomes

  1. 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.

    Time frame: 6 months

  2. 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.

    Time frame: 6 months

07

Study locations

1 site
  • Institut universitaire de gériatrie de Montréal
    Montreal, Quebec H3W1W5, Canada
08

References and documents

Publications

  • Turner 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 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2018 to primary completion in Apr 2019, 9 months.

Of 1,295 non-industry interventional studies with no phase under Chronic Pain, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 39. This study's 9 months is below that.

Counting every sponsor, half of 1,378 studies reached it within 20 months; a quarter within 9 and three quarters within 38.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 9, 2018
First posted
Jan 17, 2018
StartActual
Jul 17, 2018
Primary completionActual
Apr 30, 2019
CompletionActual
Dec 31, 2019
Last update
Sep 29, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 29, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03400384
Lead sponsor
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
Collaborators
Canadian Institutes of Health Research (CIHR)
Responsible party
Cara Tannenbaum (Professor in the faculties of Medicine and Pharmacy, University of Montreal, Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal) — Principal investigator
First posted
Jan 17, 2018
Start date
Jul 17, 2018
Primary completion
Apr 30, 2019
Completion
Dec 31, 2019
Last update
Sep 29, 2020

Study contacts

Cara Tannenbaum, MD, MSc
principal investigator · Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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