NCT04251819

Buprenorphine Plus Baclofen to Increase Analgesia in Healthy Volunteers

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Acute Pain
• Analgesia

Interventions

Type	Name	Description
DRUG	Placebos	Participants will receive placebo in combination with 0.3 mg of buprenorphine to examine analgesia in acute pain tasks.
DRUG	Baclofen 5 mg	Participants will receive 5mg of baclofen in combination with 0.3 mg of buprenorphine to examine analgesia in acute pain tasks.
DRUG	Baclofen 10mg	Participants will receive 10mg of baclofen in combination with 0.3 mg of buprenorphine to examine analgesia in acute pain tasks.

Timeline

• Start date: 2021-01-21
• Primary completion: 2024-06-15
• Completion: 2024-06-15
• First posted: 2020-02-05
• Last updated: 2026-01-07
• Results posted: 2026-01-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study