Efficacy of transdermal buprenorphine patch for managing withdrawal symptoms in patients with cancer physically dependent on prescription opioids
Background The physical dependence on prescription opioids among cancer survivors remains an under-investigated area, with a scarcity of well-designed prospective studies. Methods This single-arm, phase-2 clinical trial in Korea assessed the efficacy and safety of a transdermal buprenorphine patch (...
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Published in | The oncologist (Dayton, Ohio) Vol. 29; no. 11; pp. e1593 - e1603 |
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Main Authors | , , , , , , , , , , , , , , , |
Format | Journal Article |
Language | English |
Published |
US
Oxford University Press
01.11.2024
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Subjects | |
Online Access | Get full text |
ISSN | 1083-7159 1549-490X 1549-490X |
DOI | 10.1093/oncolo/oyae176 |
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Abstract | Background
The physical dependence on prescription opioids among cancer survivors remains an under-investigated area, with a scarcity of well-designed prospective studies.
Methods
This single-arm, phase-2 clinical trial in Korea assessed the efficacy and safety of a transdermal buprenorphine patch (TBP) in managing physical dependence on prescription opioids in cancer survivors, as confirmed through the DSM-5 criteria or psychiatric consultation for opioid withdrawal. This study involved a 4-phase treatment protocol of screening, induction/stabilization, discontinuation, and monitoring. The primary outcome was the rate of successful opioid discontinuation, as measured by a negative urine-drug screening at 8 weeks. Key secondary outcomes included the resumption of prescribed opioids, changes in both the Clinical Opioid Withdrawal Scale (COWS) and morphine equivalent daily dose (MEDD), and assessments related to the psychological and physiological aspects of dependence and safety.
Results
Thirty-one participants were enrolled. In the intention-to-treat population, the success rate of opioid discontinuation was 58%, with only 2 participants experiencing a resumption of prescribed opioids. Significant reductions were observed in MEDD, which decreased from 98 to 26 mg/day (P < .001), and COWS scores, which decreased from 5.5 to 2.8 (P < .001). Desire to use opioids reduced from 7.0 to 3.0 on a 10-point numeric rating scale (P < .001). Toxicities related to TBP were mild and manageable, without severe precipitated withdrawal symptoms.
Conclusion
TBP may be considered as an alternative therapeutic option in cancer survivors physically dependent on prescription opioids, especially where sublingual formulations are unavailable.
The transdermal buprenorphine patch may offer a promising approach for managing physical dependence on prescription opioids in cancer survivors.
Graphical Abstract
Graphical Abstract |
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AbstractList | Background: The physical dependence on prescription opioids among cancer survivors remains an under-investigated area, with a scarcity of well-designed prospective studies. Methods: This single-arm, phase-2 clinical trial in Korea assessed the efficacy and safety of a transdermal buprenorphine patch (TBP) in managing physical dependence on prescription opioids in cancer survivors, as confirmed through the DSM-5 criteria or psychiatric consultation for opioid withdrawal. This study involved a 4-phase treatment protocol of screening, induction/stabilization, discontinuation, and monitoring. The primary outcome was the rate of successful opioid discontinuation, as measured by a negative urine-drug screening at 8 weeks. Key secondary outcomes included the resumption of prescribed opioids, changes in both the Clinical Opioid Withdrawal Scale (COWS) and morphine equivalent daily dose (MEDD), and assessments related to the psychological and physiological aspects of dependence and safety. Results: Thirty-one participants were enrolled. In the intention-to-treat population, the success rate of opioid discontinuation was 58%, with only 2 participants experiencing a resumption of prescribed opioids. Significant reductions were observed in MEDD, which decreased from 98 to 26 mg/day (P < .001), and COWS scores, which decreased from 5.5 to 2.8 (P < .001). Desire to use opioids reduced from 70 to 3.0 on a 10-point numeric rating scale (P < .001). Toxicities related to TBP were mild and manageable, without severe precipitated withdrawal symptoms. Conclusion: TBP may be considered as an alternative therapeutic option in cancer survivors physically dependent on prescription opioids, especially where sublingual formulations are unavailable. Key words: opioid-related disorders; substance withdrawal syndrome; buprenorphine; cancer survivors; prescription drugs. CONCLUSION: Cancer survivors physically dependent on prescription opioids may consider discontinuing the opioids with the aid of TBP, especially in areas where sublingual formulations are unavailable. The physical dependence on prescription opioids among cancer survivors remains an under-investigated area, with a scarcity of well-designed prospective studies.BACKGROUNDThe physical dependence on prescription opioids among cancer survivors remains an under-investigated area, with a scarcity of well-designed prospective studies.This single-arm, phase-2 clinical trial in Korea assessed the efficacy and safety of a transdermal buprenorphine patch (TBP) in managing physical dependence on prescription opioids in cancer survivors, as confirmed through the DSM-5 criteria or psychiatric consultation for opioid withdrawal. This study involved a 4-phase treatment protocol of screening, induction/stabilization, discontinuation, and monitoring. The primary outcome was the rate of successful opioid discontinuation, as measured by a negative urine-drug screening at 8 weeks. Key secondary outcomes included the resumption of prescribed opioids, changes in both the Clinical Opioid Withdrawal Scale (COWS) and morphine equivalent daily dose (MEDD), and assessments related to the psychological and physiological aspects of dependence and safety.METHODSThis single-arm, phase-2 clinical trial in Korea assessed the efficacy and safety of a transdermal buprenorphine patch (TBP) in managing physical dependence on prescription opioids in cancer survivors, as confirmed through the DSM-5 criteria or psychiatric consultation for opioid withdrawal. This study involved a 4-phase treatment protocol of screening, induction/stabilization, discontinuation, and monitoring. The primary outcome was the rate of successful opioid discontinuation, as measured by a negative urine-drug screening at 8 weeks. Key secondary outcomes included the resumption of prescribed opioids, changes in both the Clinical Opioid Withdrawal Scale (COWS) and morphine equivalent daily dose (MEDD), and assessments related to the psychological and physiological aspects of dependence and safety.Thirty-one participants were enrolled. In the intention-to-treat population, the success rate of opioid discontinuation was 58%, with only 2 participants experiencing a resumption of prescribed opioids. Significant reductions were observed in MEDD, which decreased from 98 to 26 mg/day (P < .001), and COWS scores, which decreased from 5.5 to 2.8 (P < .001). Desire to use opioids reduced from 7.0 to 3.0 on a 10-point numeric rating scale (P < .001). Toxicities related to TBP were mild and manageable, without severe precipitated withdrawal symptoms.RESULTSThirty-one participants were enrolled. In the intention-to-treat population, the success rate of opioid discontinuation was 58%, with only 2 participants experiencing a resumption of prescribed opioids. Significant reductions were observed in MEDD, which decreased from 98 to 26 mg/day (P < .001), and COWS scores, which decreased from 5.5 to 2.8 (P < .001). Desire to use opioids reduced from 7.0 to 3.0 on a 10-point numeric rating scale (P < .001). Toxicities related to TBP were mild and manageable, without severe precipitated withdrawal symptoms.TBP may be considered as an alternative therapeutic option in cancer survivors physically dependent on prescription opioids, especially where sublingual formulations are unavailable.CONCLUSIONTBP may be considered as an alternative therapeutic option in cancer survivors physically dependent on prescription opioids, especially where sublingual formulations are unavailable. Background The physical dependence on prescription opioids among cancer survivors remains an under-investigated area, with a scarcity of well-designed prospective studies. Methods This single-arm, phase-2 clinical trial in Korea assessed the efficacy and safety of a transdermal buprenorphine patch (TBP) in managing physical dependence on prescription opioids in cancer survivors, as confirmed through the DSM-5 criteria or psychiatric consultation for opioid withdrawal. This study involved a 4-phase treatment protocol of screening, induction/stabilization, discontinuation, and monitoring. The primary outcome was the rate of successful opioid discontinuation, as measured by a negative urine-drug screening at 8 weeks. Key secondary outcomes included the resumption of prescribed opioids, changes in both the Clinical Opioid Withdrawal Scale (COWS) and morphine equivalent daily dose (MEDD), and assessments related to the psychological and physiological aspects of dependence and safety. Results Thirty-one participants were enrolled. In the intention-to-treat population, the success rate of opioid discontinuation was 58%, with only 2 participants experiencing a resumption of prescribed opioids. Significant reductions were observed in MEDD, which decreased from 98 to 26 mg/day (P < .001), and COWS scores, which decreased from 5.5 to 2.8 (P < .001). Desire to use opioids reduced from 7.0 to 3.0 on a 10-point numeric rating scale (P < .001). Toxicities related to TBP were mild and manageable, without severe precipitated withdrawal symptoms. Conclusion TBP may be considered as an alternative therapeutic option in cancer survivors physically dependent on prescription opioids, especially where sublingual formulations are unavailable. The physical dependence on prescription opioids among cancer survivors remains an under-investigated area, with a scarcity of well-designed prospective studies. This single-arm, phase-2 clinical trial in Korea assessed the efficacy and safety of a transdermal buprenorphine patch (TBP) in managing physical dependence on prescription opioids in cancer survivors, as confirmed through the DSM-5 criteria or psychiatric consultation for opioid withdrawal. This study involved a 4-phase treatment protocol of screening, induction/stabilization, discontinuation, and monitoring. The primary outcome was the rate of successful opioid discontinuation, as measured by a negative urine-drug screening at 8 weeks. Key secondary outcomes included the resumption of prescribed opioids, changes in both the Clinical Opioid Withdrawal Scale (COWS) and morphine equivalent daily dose (MEDD), and assessments related to the psychological and physiological aspects of dependence and safety. Thirty-one participants were enrolled. In the intention-to-treat population, the success rate of opioid discontinuation was 58%, with only 2 participants experiencing a resumption of prescribed opioids. Significant reductions were observed in MEDD, which decreased from 98 to 26 mg/day (P < .001), and COWS scores, which decreased from 5.5 to 2.8 (P < .001). Desire to use opioids reduced from 7.0 to 3.0 on a 10-point numeric rating scale (P < .001). Toxicities related to TBP were mild and manageable, without severe precipitated withdrawal symptoms. TBP may be considered as an alternative therapeutic option in cancer survivors physically dependent on prescription opioids, especially where sublingual formulations are unavailable. The transdermal buprenorphine patch may offer a promising approach for managing physical dependence on prescription opioids in cancer survivors. Graphical Abstract Background The physical dependence on prescription opioids among cancer survivors remains an under-investigated area, with a scarcity of well-designed prospective studies. Methods This single-arm, phase-2 clinical trial in Korea assessed the efficacy and safety of a transdermal buprenorphine patch (TBP) in managing physical dependence on prescription opioids in cancer survivors, as confirmed through the DSM-5 criteria or psychiatric consultation for opioid withdrawal. This study involved a 4-phase treatment protocol of screening, induction/stabilization, discontinuation, and monitoring. The primary outcome was the rate of successful opioid discontinuation, as measured by a negative urine-drug screening at 8 weeks. Key secondary outcomes included the resumption of prescribed opioids, changes in both the Clinical Opioid Withdrawal Scale (COWS) and morphine equivalent daily dose (MEDD), and assessments related to the psychological and physiological aspects of dependence and safety. Results Thirty-one participants were enrolled. In the intention-to-treat population, the success rate of opioid discontinuation was 58%, with only 2 participants experiencing a resumption of prescribed opioids. Significant reductions were observed in MEDD, which decreased from 98 to 26 mg/day (P < .001), and COWS scores, which decreased from 5.5 to 2.8 (P < .001). Desire to use opioids reduced from 7.0 to 3.0 on a 10-point numeric rating scale (P < .001). Toxicities related to TBP were mild and manageable, without severe precipitated withdrawal symptoms. Conclusion TBP may be considered as an alternative therapeutic option in cancer survivors physically dependent on prescription opioids, especially where sublingual formulations are unavailable. The transdermal buprenorphine patch may offer a promising approach for managing physical dependence on prescription opioids in cancer survivors. Graphical Abstract Graphical Abstract |
Audience | Professional Academic |
Author | Lee, Guk Jin Lee, Dongyun Ji, Jun Ho Choi, Jung Woo Lee, Kyung Hee Kim, Il Hwan Go, Se-Il Oh, Sung Yong Kang, Jung Hun Koo, Dong-Hoe Hwang, In Gyu Koh, Su-Jin Seo, Seyoung Shin, Seong-Hoon Huh, Seok Jae Chun, Sang Hoon |
Author_xml | – sequence: 1 givenname: Jung Hun surname: Kang fullname: Kang, Jung Hun – sequence: 2 givenname: Kyung Hee surname: Lee fullname: Lee, Kyung Hee – sequence: 3 givenname: Seok Jae surname: Huh fullname: Huh, Seok Jae – sequence: 4 givenname: Seong-Hoon surname: Shin fullname: Shin, Seong-Hoon – sequence: 5 givenname: Il Hwan surname: Kim fullname: Kim, Il Hwan – sequence: 6 givenname: In Gyu surname: Hwang fullname: Hwang, In Gyu – sequence: 7 givenname: Dong-Hoe surname: Koo fullname: Koo, Dong-Hoe – sequence: 8 givenname: Dongyun surname: Lee fullname: Lee, Dongyun – sequence: 9 givenname: Su-Jin surname: Koh fullname: Koh, Su-Jin – sequence: 10 givenname: Seyoung surname: Seo fullname: Seo, Seyoung – sequence: 11 givenname: Guk Jin surname: Lee fullname: Lee, Guk Jin – sequence: 12 givenname: Sang Hoon surname: Chun fullname: Chun, Sang Hoon – sequence: 13 givenname: Jun Ho surname: Ji fullname: Ji, Jun Ho – sequence: 14 givenname: Sung Yong surname: Oh fullname: Oh, Sung Yong – sequence: 15 givenname: Jung Woo surname: Choi fullname: Choi, Jung Woo – sequence: 16 givenname: Se-Il orcidid: 0000-0002-3025-6096 surname: Go fullname: Go, Se-Il email: gose1@gnu.ac.kr |
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Keywords | substance withdrawal syndrome buprenorphine opioid-related disorders cancer survivors prescription drugs |
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The physical dependence on prescription opioids among cancer survivors remains an under-investigated area, with a scarcity of well-designed... The physical dependence on prescription opioids among cancer survivors remains an under-investigated area, with a scarcity of well-designed prospective... Background: The physical dependence on prescription opioids among cancer survivors remains an under-investigated area, with a scarcity of well-designed... Background The physical dependence on prescription opioids among cancer survivors remains an under-investigated area, with a scarcity of well-designed... The transdermal buprenorphine patch may offer a promising approach for managing physical dependence on prescription opioids in cancer survivors. Graphical... |
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SubjectTerms | Adult Aged Analgesics, Opioid - administration & dosage Analgesics, Opioid - adverse effects Analgesics, Opioid - therapeutic use Buprenorphine Buprenorphine - administration & dosage Buprenorphine - therapeutic use Cancer Cancer patients Dosage and administration Drug therapy Drug withdrawal Drug withdrawal symptoms Female Humans Male Middle Aged Narcotics Neoplasms - complications Neoplasms - drug therapy Opioid-Related Disorders - drug therapy Prescription drugs Prospective Studies Substance Withdrawal Syndrome - drug therapy Symptom Management and Supportive Care Testing Transdermal medication Transdermal Patch |
Title | Efficacy of transdermal buprenorphine patch for managing withdrawal symptoms in patients with cancer physically dependent on prescription opioids |
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