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Assessment of pioglitazone and proinflammatory cytokines during buprenorphine taper in patients with opioid use disorder.

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Title: Assessment of pioglitazone and proinflammatory cytokines during buprenorphine taper in patients with opioid use disorder.
Authors: Schroeder, Jennifer R., Phillips, Karran A., Epstein, David H., Jobes, Michelle L., Furnari, Melody A., Kennedy, Ashley P., Heilig, Markus, Preston, Kenzie L.
Source: Psychopharmacology. Oct2018, Vol. 235 Issue 10, p2957-2966. 10p. 1 Diagram, 2 Charts, 2 Graphs.
Subjects: Drug abuse treatment, Opioid abuse, Pioglitazone, Buprenorphine, Cytokines, Drug withdrawal symptoms
Abstract: Background: Preliminary evidence suggested that the PPARγ agonist pioglitazone reduces opioid-withdrawal symptoms, possibly by inhibiting increases in proinflammatory cytokines.Methods: A randomized, placebo-controlled clinical trial was conducted utilizing two different study designs (entirely outpatient, and a combination of inpatient and outpatient) to evaluate the safety and efficacy of pioglitazone as an adjunct medication for people with opioid physical dependence undergoing a buprenorphine taper. Participants were stabilized on buprenorphine/naloxone (sublingual, up to 16/4 mg/day), then randomized to receive oral pioglitazone (up to 45 mg/day) or placebo before, during, and after buprenorphine taper. Outcome measures included the Subjective Opiate Withdrawal Scale (SOWS) and Clinical Opiate Withdrawal Scale, use of rescue medications to alleviate opioid withdrawal symptoms, and opioid-positive urine specimens. Cerebrospinal fluid (CSF) and plasma were collected during the taper in a subset of participants for measurement of proinflammatory cytokines.Results: The clinical trial was prematurely terminated due to slow enrollment; 40 participants per group were required for adequate statistical power to test study hypotheses. Twenty-four participants enrolled; 17 received at least one dose of study medication (6 pioglitazone, 11 placebo). SOWS scores were higher in the pioglitazone arm than in the placebo arm after adjusting for use of rescue medications; participants in the pioglitazone arm needed more rescue medications than the placebo arm during the post-taper phase. SOWS scores were positively correlated with monocyte chemoattractant protein-1 (MCP-1) in CSF (r = 0.70, p = 0.038) and plasma (r = 0.77, p = 0.015). Participants having higher levels of plasma MCP-1 reported higher SOWS, most notably after the buprenorphine taper ended.Conclusions: Results from this study provide no evidence that pioglitazone reduces opioid withdrawal symptoms during buprenorphine taper. High correlations between MCP-1 and opioid withdrawal symptoms support a role of proinflammatory processes in opioid withdrawal.Trial registration: clinicaltrials.gov identifier: NCT01517165 [ABSTRACT FROM AUTHOR]
Copyright of Psychopharmacology is the property of Springer Nature and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
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  Data: Assessment of pioglitazone and proinflammatory cytokines during buprenorphine taper in patients with opioid use disorder.
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  Data: <searchLink fieldCode="AR" term="%22Schroeder%2C+Jennifer+R%2E%22">Schroeder, Jennifer R.</searchLink><br /><searchLink fieldCode="AR" term="%22Phillips%2C+Karran+A%2E%22">Phillips, Karran A.</searchLink><br /><searchLink fieldCode="AR" term="%22Epstein%2C+David+H%2E%22">Epstein, David H.</searchLink><br /><searchLink fieldCode="AR" term="%22Jobes%2C+Michelle+L%2E%22">Jobes, Michelle L.</searchLink><br /><searchLink fieldCode="AR" term="%22Furnari%2C+Melody+A%2E%22">Furnari, Melody A.</searchLink><br /><searchLink fieldCode="AR" term="%22Kennedy%2C+Ashley+P%2E%22">Kennedy, Ashley P.</searchLink><br /><searchLink fieldCode="AR" term="%22Heilig%2C+Markus%22">Heilig, Markus</searchLink><br /><searchLink fieldCode="AR" term="%22Preston%2C+Kenzie+L%2E%22">Preston, Kenzie L.</searchLink>
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  Data: <searchLink fieldCode="JN" term="%22Psychopharmacology%22">Psychopharmacology</searchLink>. Oct2018, Vol. 235 Issue 10, p2957-2966. 10p. 1 Diagram, 2 Charts, 2 Graphs.
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  Data: <searchLink fieldCode="DE" term="%22Drug+abuse+treatment%22">Drug abuse treatment</searchLink><br /><searchLink fieldCode="DE" term="%22Opioid+abuse%22">Opioid abuse</searchLink><br /><searchLink fieldCode="DE" term="%22Pioglitazone%22">Pioglitazone</searchLink><br /><searchLink fieldCode="DE" term="%22Buprenorphine%22">Buprenorphine</searchLink><br /><searchLink fieldCode="DE" term="%22Cytokines%22">Cytokines</searchLink><br /><searchLink fieldCode="DE" term="%22Drug+withdrawal+symptoms%22">Drug withdrawal symptoms</searchLink>
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  Data: Background: Preliminary evidence suggested that the PPARγ agonist pioglitazone reduces opioid-withdrawal symptoms, possibly by inhibiting increases in proinflammatory cytokines.Methods: A randomized, placebo-controlled clinical trial was conducted utilizing two different study designs (entirely outpatient, and a combination of inpatient and outpatient) to evaluate the safety and efficacy of pioglitazone as an adjunct medication for people with opioid physical dependence undergoing a buprenorphine taper. Participants were stabilized on buprenorphine/naloxone (sublingual, up to 16/4 mg/day), then randomized to receive oral pioglitazone (up to 45 mg/day) or placebo before, during, and after buprenorphine taper. Outcome measures included the Subjective Opiate Withdrawal Scale (SOWS) and Clinical Opiate Withdrawal Scale, use of rescue medications to alleviate opioid withdrawal symptoms, and opioid-positive urine specimens. Cerebrospinal fluid (CSF) and plasma were collected during the taper in a subset of participants for measurement of proinflammatory cytokines.Results: The clinical trial was prematurely terminated due to slow enrollment; 40 participants per group were required for adequate statistical power to test study hypotheses. Twenty-four participants enrolled; 17 received at least one dose of study medication (6 pioglitazone, 11 placebo). SOWS scores were higher in the pioglitazone arm than in the placebo arm after adjusting for use of rescue medications; participants in the pioglitazone arm needed more rescue medications than the placebo arm during the post-taper phase. SOWS scores were positively correlated with monocyte chemoattractant protein-1 (MCP-1) in CSF (r = 0.70, p = 0.038) and plasma (r = 0.77, p = 0.015). Participants having higher levels of plasma MCP-1 reported higher SOWS, most notably after the buprenorphine taper ended.Conclusions: Results from this study provide no evidence that pioglitazone reduces opioid withdrawal symptoms during buprenorphine taper. High correlations between MCP-1 and opioid withdrawal symptoms support a role of proinflammatory processes in opioid withdrawal.Trial registration: <ext-link>clinicaltrials.gov</ext-link> identifier: NCT01517165 [ABSTRACT FROM AUTHOR]
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  Data: <i>Copyright of Psychopharmacology is the property of Springer Nature and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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        Value: 10.1007/s00213-018-4986-5
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      – SubjectFull: Drug abuse treatment
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      – SubjectFull: Pioglitazone
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      – SubjectFull: Buprenorphine
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      – SubjectFull: Cytokines
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              Text: Oct2018
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