NCT03485430

Tapering From Long-term Opioid Therapy in Chronic Pain Population. Randomized Controlled Trial With 12 Months Follow up

Tapering of Prescribed Opioids in Patients With Long-term Non-malignant Pain - Efficacy and Effects on Pain, Pain Cognitions, and Quality of Life (TOPIO): a Study Protocol for a Randomized Controlled Clinical Trial With a 12 Month Follow-up

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Lund University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Chronic non-cancer pain is a major problem in society and a common cause to seek health care. The suffering is complex as it, besides pain, often includes psychological symptoms and may decrease the ability to participate in work life. Pharmacological treatments have limited possibilities to ease suffering. Opioids used in this population have evidence to ease pain and to some extent increase physical ability when used in limited treatment periods and in selected patients. Medium to long-term opioid therapy, extended beyond three months, lack evidence of easing pain or increase physical ability. The current study is conducted on three specialized pain care units (Skane University Hospital; Lund, Sahlgrenska University Hospital Gothenburg and University Hospital, Linkoeping) and aims at taper long-term opioid therapy with support from physician and nurse and study the effects of tapering. Method: Randomized controlled study, without concealment. Waiting-list constitutes the control-group. Intervention means tapering with a motivated patient. Follow up at four and twelve months. Primary end-point: collected opioid prescriptions registered in The National Board of Health and Welfare registry expressed in milligram of morphine equivalent. Secondary end-point: Data will be retrieved from the Swedish Quality Registry for Pain Rehabilitation. The database contains participants' self-report of variables measuring the impact of rehabilitation on depressive symptoms, anxiety, rating of pain and acceptance to pain. Assessments are made prior to, at the end of and one year after discharge of the rehabilitation program. As denying tapering or participation is shown to be as common as decision to taper drugs at baseline an extended ethical approval was acquired also retrospective. This approval covers obtaining collected prescribed medication and prescribed opioid replacement therapy (Buprenorphine or Methadone) after one year. The study may describe the excluded population better this way.

Conditions

• Chronic Pain
• Analgesics, Opioid
• Opioid Withdrawal
• Opioid Use
• Substance Use Disorders

Interventions

Type	Name	Description
BEHAVIORAL	Tapering	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.

Timeline

• Start date: 2018-03-22
• Primary completion: 2024-09-18
• Completion: 2025-12-30
• First posted: 2018-04-02
• Last updated: 2025-03-07

Locations

3 sites across 1 country: Sweden