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

NCT ID: NCT03400384

Last Updated: 2020-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

4255 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-17

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Inappropriate Dose of Drug Administered Pain, Chronic Health Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Direct-to-consumer educational brochure

Intervention Type OTHER

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.

Control wait list

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal

OTHER

Sponsor Role lead

Responsible Party

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Cara Tannenbaum

Professor in the faculties of Medicine and Pharmacy, University of Montreal

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cara Tannenbaum, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal

Locations

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Institut universitaire de gériatrie de Montréal

Montreal, Quebec, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 38809554 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31288859 (View on PubMed)

Other Identifiers

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CIHR 201506PHSI-337814-MB

Identifier Type: -

Identifier Source: org_study_id

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