physical dependence on opioids in cancer patients
- Conditions
- Neoplasms
- Registration Number
- KCT0005159
- Lead Sponsor
- Gyeongsang National University Changwon Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 53
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
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Success rate of opioid discontinuation [Negative urine drug screening (UDS) after 8 weeks of opioid discontinuation]
- Secondary Outcome Measures
Name Time Method 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