Buprenorphine Plus Baclofen to Increase Analgesia in Healthy Volunteers

The University of Alabama at Birmingham

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Analgesia; Acute Pain

Treatments: Drug: Placebos; Drug: Baclofen 10mg; Drug: Baclofen 5 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT04251819

300004505

Details and patient eligibility

About

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

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18 years or older
• general good health
• English speaking

Exclusion criteria

• Pregnant or nursing
• Opioid use disorder or any substance use disorder other than nicotine
• Prescribed agonist treatment for opioid dependence or prescribed opioids for a medical condition
• Prescribed naltrexone
• Known sensitivity to buprenorphine, naloxone, or baclofen
• Acute or chronic pain condition
• Trouble breathing or a pulmonary condition
• Prescribed benzodiazepines or daily use of benzodiazepines
• Positive drug screen (positive cannabis result allowed)
• Cognitive impairment or psychiatric disorder requiring treatment
• Uncontrolled hypertension

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Participants randomized to this arm will receive Placebo.

Treatment:

Drug: Placebos

Baclofen 5mg

Experimental group

Description:

Participants randomized to this arm will receive 5 mg of Baclofen.

Treatment:

Drug: Baclofen 5 mg

Baclofen 10mg

Experimental group

Description:

Participants randomized to this arm will receive 10 mg of Baclofen.

Treatment:

Drug: Baclofen 10mg