Buprenorphine Plus Baclofen to Increase Analgesia in Healthy Volunteers

NCT ID: NCT04251819

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-21
• Study Completion Date: 2024-06-15

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Placebo

Participants randomized to this arm will receive one dosage of Placebo as part of their second study appointment.

Group Type: PLACEBO_COMPARATOR

Placebos

Intervention Type: DRUG

Participants will receive placebo in combination with 0.3 mg of buprenorphine to examine analgesia in acute pain tasks.

Baclofen 5mg

Participants randomized to this arm will receive one dosage of 5 mg of Baclofen as part of their second study appointment.

Group Type: EXPERIMENTAL

Baclofen 5 mg

Intervention Type: DRUG

Participants will receive 5mg of baclofen in combination with 0.3 mg of buprenorphine to examine analgesia in acute pain tasks.

Baclofen 10mg

Participants randomized to this arm will receive one dosage of 10 mg of Baclofen as part of their second study appointment.

Group Type: EXPERIMENTAL

Baclofen 10mg

Intervention Type: DRUG

Participants will receive 10mg of baclofen in combination with 0.3 mg of buprenorphine to examine analgesia in acute pain tasks.

Interventions

Placebos

Participants will receive placebo in combination with 0.3 mg of buprenorphine to examine analgesia in acute pain tasks.

Intervention Type: 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.

Intervention Type: DRUG

Baclofen 10mg

Participants will receive 10mg of baclofen in combination with 0.3 mg of buprenorphine to examine analgesia in acute pain tasks.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Karen Cropsey

Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karen L Cropsey, Psy.D.

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama, Birmingham

Birmingham, Alabama, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

300004505

Identifier Type: -

Identifier Source: org_study_id