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physical dependence on opioids in cancer patients

Efficacy and safety of transdermal buprenorphine patch in cancer patients who are physically dependent on opioids

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CRIS
Registry ID
KCT0005159
Enrollment
53
Registered
2020-06-23
Start date
2020-08-17
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : 1st. Screening phase 2nd. Induction and stabilization phase (first 1 – 6 weeks) - Convert into TBP with 75 – 100% of equivalent dose of the culprit strong opioids and stop all strong opioid ex

Sponsors

Gyeongsang National University Changwon Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. age: 18 years or old 2. those who have willing to participate in the trial 3. cancer patients who have been prescribed opioids of MEDD 80 mg or less and who were physically dependent on offending opioids 4. consistent with DSM-5 diagnostic criteria for opioid withdrawal 5. those in whom there is no evidence of cancer or cancer have not progressed for more than 6 months 6. appropriate bone marrow, renal, and hepatic function

Exclusion criteria

Exclusion criteria: 1. co-morbid dependence on high doses of benzodiazepines or other central nervous system depressants or alcohol 2. hypersensitivity on buprenorphine 3. those who were treated with MAO inhibitors during the last 2 weeks 4. pregnant or potential to become pregnant 5. severe respiratory impairment 6. significant untreated psychiatric comorbidity including depressive disorders, antisocial and borderline personality disorder 7. active or chronic suicidal or homicidal ideation or attempts 8. significant medical complications which are prioritized over participating study 9. patients who have a significant pain (more than NRS 4) or who are unable to manage cancer pain without opioids 10. history of being prescribed buprenorphine for any purpose in the last 8 weeks

Design outcomes

Primary

MeasureTime frame
Success rate of opioid discontinuation [Negative urine drug screening (UDS) after 8 weeks of opioid discontinuation]

Secondary

MeasureTime frame
Success rate of opioid discontinuation (by history taking, counselling);Clinical Opioid Withdrawal Scale (COWS);Numeric rating scale (NRS) for desire to use opioids;Quality of life (QoL);adverse events

Countries

Korea, Republic of

Contacts

Public ContactSE IL KO

Gyeongsang National University Changwon Hospital

gose1@hanmail.net+82-55-214-3752

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026