NCT03485430

Brief Summary

This randomized controlled study compares tapering of long-term opioid therapy in a population with chronic non-cancer pain with control group constituted of waiting list. Half of participants receives intervention at baseline and the other half are controls but receives intervention after 4 months. Ethical approval to follow up excluded participants denying tapering at baseline.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P75+ for not_applicable chronic-pain

Timeline
Completed

Started Mar 2018

Longer than P75 for not_applicable chronic-pain

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 22, 2018

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 26, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 2, 2018

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

April 20, 2026

Status Verified

April 1, 2026

Enrollment Period

6.5 years

First QC Date

March 26, 2018

Last Update Submit

April 15, 2026

Conditions

Analgesics, OpioidOpioid WithdrawalSubstance Use DisordersChronic PainOpioid Use

Outcome Measures

Primary Outcomes (2)

  • Opioid consumption

    Data retrieved from National Boars of Health and Welfare, collected prescribed opioid drugs

    12 months

  • Opioid consumption

    Self reported consumption

    4 months

Secondary Outcomes (1)

  • Numeric Pain Rating Scale (NPRS)

    12 months

Other Outcomes (5)

  • Hospital Anxiety and Depression scale (HADS)

    12 months

  • Tampa Scale for Kinesiophobia (TSK)

    12 months

  • Pain Catastrophizing Scale (PCS)

    12 months

  • +2 more other outcomes

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Receives tapering of opioid dose at baseline

Behavioral: Tapering

Control

NO INTERVENTION

Waiting-list. Receives tapering after 4 months.

Interventions

TaperingBEHAVIORAL

Tapering with follow up by nurse at weekly basis in beginning of tapering. Tapering in an outpatient setting. Follow-up to doctor after four months.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A long-term opioid therapy with daily intake due to chronic pain condition, by prescription. Willing to enter an intervention aiming at taper opioid therapy.

You may not qualify if:

  • No daily intake of opioids. Shorter duration of opioid therapy than 3 months. Repeated intake of non-prescribed opioids or other illegal drugs. Refusal to perform drug-screening Perceived medical risks of waiting with tapering of opioids (e.g: raising opioid doses after acute pancreatitis caused by excessive alcohol intake or kidney disease stage 4-5 in combination with excessive alcohol intake and high doses of opioids).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Lund University Hospital

Lund, Skåne County, 22100, Sweden

Location

Paincentre Sahlgrenska University Hospital

Gothenburg, Västra Götaland County, Sweden

Location

Pain and rehabilitation centre Linköping University Hospital

Linköping, Östergötland County, Sweden

Location

Related Publications (1)

  • Henrik G, Patrik M, Anders H, Ulf J, Marcelo RF, Asa R. Tapering of prescribed opioids in patients with long-term non-malignant pain (TOPIO)-efficacy and effects on pain, pain cognitions, and quality of life: a study protocol for a randomized controlled clinical trial with a 12-month follow-up. Trials. 2021 Jul 28;22(1):503. doi: 10.1186/s13063-021-05449-5.

    PMID: 34321058RESULT

MeSH Terms

Conditions

Chronic PainSubstance-Related Disorders

Interventions

Drug Tapering

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Study Officials

  • Åsa IRingqvist, MD, PhD

    Lund University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2018

First Posted

April 2, 2018

Study Start

March 22, 2018

Primary Completion

September 18, 2024

Study Completion

September 30, 2025

Last Updated

April 20, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

All data are available upon reasonable request. In the event of data sharing, a formal agreement outlining the secure handling of said data will be drawn up. Sharing dataset will include program code as well as the detailed prewritten and signed statistical analysis plan.

Locations

SE(3)