Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
75 participants
INTERVENTIONAL
2009-02-02
2014-12-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
AIMS
This study aimed at:
1. evaluating the feasibility of a opioid tapering off program to patients with chronic pain,
2. investigating the influence of opioid tapering off on cognitive function, pain, symptoms of opioid withdrawal, anxiety , depression, and health related quality of life,
3. investigating the prevalence of addiction in chronic pain patients in a long-term treatment,
4. determining the predictive value of the Pain Medication Questionnaire (PMQ) in patients with chronic pain,
5. investigating how opioid tapering off influences PMQ.
METHODS
Study design
This is a prospective, single centre, open-label, parallel-group randomized controlled trial (1:1) conducted at the Multidisciplinary Pain Centre of Rigshospitalet, Copenhagen University Hospital, Denmark.
Two phases with nine assessments were planned. The Phase 1 was the stabilization phase and consisted of two assessments: the first assessment (baseline) was done when patients were admitted to the pain centre and the second assessment was done when medical treatment was considered stable for at least three weeks (stable dose levels and regular intervals). In the following patients went through Phase 2 and were randomized to receive the intervention (Taper off Group) or continue the same stable treatment (Control Group). Seven assessments were planned to this phase: third and fourth assessments were done in intervals of two to three weeks and the following assessments (fifth to ninth) with intervals of one month in between.
Intervention
The taper-off intervention consisted of a reduction of 10% of the daily opioid dose every 1-2 weeks until discontinuation of opioid treatment for up to six months. Clonidine use (25mg - 150mg/day) was allowed in cases of opioid withdrawal symptoms, according to medical prescription.
Analysis
Statistical analysis will be performed to compare baseline characteristics between groups (patients that complete the study vs. patients that dropped out and intervention vs. control group). Comparative analysis of primary and secondary outcomes between groups will also be performed to identify significant differences associated with the intervention.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Taper off
Decrease of opioid daily dose until discontinuation for up to six months.
Opioids taper off
Decrease of 10% of opioid daily dose every one to two weeks until discontinuation for up to six months.
Control Group
No changes on opioids and adjuvant medication for up to six months.
Opioid stable treatment
No changes on prescribed opioids and adjuvant medication for the next six months
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Opioids taper off
Decrease of 10% of opioid daily dose every one to two weeks until discontinuation for up to six months.
Opioid stable treatment
No changes on prescribed opioids and adjuvant medication for the next six months
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* at least seven years of schooling
* pain duration of at least six months,
* treatment with oral opioids for more than three months
* daily opioid dose ≥ 60 mg of oral morphine equivalent
Exclusion Criteria
* cancer disease
* poor general health condition
* pregnancy, dementia
* encephalopathy
* brain damage
* cranial base trauma
* enrolled in other studies
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The Ministry of Science, Technology and Innovation, Denmark
OTHER_GOV
Hørslev-Fonden
UNKNOWN
Rigshospitalet, Denmark
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Per Sjogren
Professor in palliative Medicine
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Per Sjøgren, DMSc
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet, Denmark
Jette Højsted, MD
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet, Denmark
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
H-B-2008-061
Identifier Type: -
Identifier Source: org_study_id