Clinical trial NCT04251819: Buprenorphine Plus Baclofen to Increase Analgesia in Healthy Volunteers
Official title: Buprenorphine Plus Baclofen to Increase Analgesia in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Acute Pain
Analgesia
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to one of three interventions.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pain Threshold
timeFrame: Baseline
measure: Pain Threshold
timeFrame: Baseline through one week
measure: Pain tolerance
timeFrame: Baseline
measure: Pain tolerance
timeFrame: Baseline through one week
measure: Temporal summation of pain
timeFrame: Baseline
measure: Temporal summation of pain
timeFrame: Baseline through one week
measure: Conditioned pain modulation
timeFrame: Baseline
measure: Conditioned pain modulation
timeFrame: Baseline through one week
measure: Suprathreshold pain response
timeFrame: Baseline
measure: Suprathreshold pain response
timeFrame: Baseline through one week
Secondary outcomes:
measure: Opioid Symptom Checklist
timeFrame: One to seven days post baseline
measure: McGill Pain Questionnaire-Short Form
timeFrame: One to seven days post baseline
measure: 26-item Visual Analog Scale (VAS)
timeFrame: One to seven days post baseline
measure: Drug Effects Questionnaire-5
timeFrame: One to seven days post baseline
measure: 26-item Visual Analog Scale ("Subjective drug effects")
timeFrame: One to seven days post baseline
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama, Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Karen L Cropsey, Psy.D.
role: PRINCIPAL_INVESTIGATOR
References: