Buprenorphine Plus Baclofen to Increase Analgesia in Healthy Volunteers

Status Active, not recruiting

Clinical Trial Summary

To determine if baclofen will enhance buprenorphine analgesia for acute pain in healthy volunteers.

Clinical Trial Description

Abuse of opioids is a significant and growing problem in the United States. In the past two decades, opioid prescriptions have quadrupled while the age of heroin initiation has decreased, suggesting that more individuals are using opioids and transitioning to heroin and potent synthetic opioids than in the past. Further, fatal opioid overdose is now the leading cause of accidental death and is the 5th highest overall cause of mortality in the US. Engaging opioid users in opioid agonist treatments has been shown to lower rates of criminal behavior, lower rates of non-opioid drug use, and increase retention in drug treatment programs, while decreasing mortality and new HIV and hepatitis infections. However, a recent study noted that 68% of patients prescribed buprenorphine had poor medication adherence, which was associated with illicit opioid use. A Cochrane review concluded that buprenorphine was less effective at retaining patients in treatment relative to methadone. One reason for lower treatment retention may be the high comorbidity of opioid use disorder and chronic pain and/or opioid-induced hyperalgesia. Buprenorphine, as a partial mu agonist, provides lower analgesia but an improved safety profile relative to full agonists like methadone. Thus, enhancing the analgesic properties of buprenorphine will provide a safer alternative for opioid use disorder patients with chronic pain/hyperalgesia. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04251819
Study type	Interventional
Source	University of Alabama at Birmingham
Contact
Status	Active, not recruiting
Phase	Phase 2/Phase 3
Start date	January 21, 2021
Completion date	June 2025

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