Study of the Treatment of Experimental Pain in Buprenorphine Maintained Persons With Chronic Musculoskeletal Pain (1401)

Analgesic Effects and Abuse Liability of Intravenous Hydromorphone and Buprenorphine in Opioid Dependent Participants With Chronic Musculoskeletal Pain

Pain is very common in persons with a history of addiction, but few studies have examined the best treatment of pain in this population. This is a study to determine the pain relief provided by intravenous hydromorphone (Dilaudid) or buprenorphine given to persons maintained on stable doses of methadone or buprenorphine who have chronic musculoskeletal pain. Experimental sessions will require overnight stays on a residential research unit. In these sessions, persons will be exposed to standard experimental pain techniques at baseline and then rate the relief (if any) provided by the study medication when exposed to the same techniques. Persons will be asked to participate in 3 sessions, each separated by at least 7 days.

Study Overview

• Status: Completed
• Conditions: Chronic Pain; Opioid-Related Disorders
• Intervention / Treatment: Drug: Placebo; Drug: Hydromorphone; Drug: Buprenorphine

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Behavioral Pharmacology Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Opioid dependence according to the Mini International Neuropsychiatric Interview (MINI) and verified by the PI; urine toxicology negative for drugs of abuse but positive for opioid maintenance agent; stable buprenorphine (12-16 mg) dose for the past 30 days; chronic musculoskeletal pain (>3 months) as documented in medical history and physical; able and willing to perform/tolerate pain procedures; able to communicate in English.

Exclusion Criteria:

Current illicit substance use at screening or during trial as verified by urine toxicology screen and/or self-report (including cannabis use); current alcohol dependence as assessed on the MINI); medical or psychiatric condition known to influence quantitative sensory testing (QST) (e.g. HIV, peripheral neuropathy, current Major Depressive Disorder, Schizophrenia, Raynaud's syndrome); use of prescribed or over the counter analgesic agents or psychotropic medications known to have analgesic properties for 24 hours prior to session; previous allergic reaction to hydromorphone or buprenorphine; women who are pregnant, lactating or planning to get pregnant during the course of the trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Intravenous injection of approximately 10 mL administered via slow push over 5 minutes. Given 4 injections during the session with each injection separated by 1.5 hours.; Other Names: Normal Saline
Active Comparator: Hydromorphone	Drug: Hydromorphone; Intravenous injection of approximately 10 mL administered via slow push over 5 minutes. Given 4 injections during the session with each injection separated by 1.5 hours.; Other Names: Dilaudid
Experimental: Buprenorphine	Drug: Buprenorphine; Intravenous injection of approximately 10 mL administered via slow push over 5 minutes. Given 4 injections during the session with each injection separated by 1.5 hours.; Other Names: Subutex; Suboxone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cold pressor test	The participant places a hand up to the wrist in a circulating water bath maintained at approximately 4 degrees Celsius (up to 5 minutes). The time at which pain develops is the threshold. The time a volunteer's hand remains underwater before pain is unbearable is tolerance.	This will be measured 7 times during each 40-hour session. On average, all sessions will be completed within 4 weeks.

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: D. Andrew Tompkins, M.D. M.H.S., Johns Hopkins University

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: February 20, 2015
• First Submitted That Met QC Criteria: February 20, 2015
• First Posted (Estimate): February 26, 2015

Study Record Updates

• Last Update Posted (Actual): September 11, 2017
• Last Update Submitted That Met QC Criteria: September 7, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Quantitative Sensory Testing; Buprenorphine; Hydromorphone
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Narcotic-Related Disorders; Chronic Pain; Opioid-Related Disorders; Musculoskeletal Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Narcotic Antagonists; Buprenorphine; Hydromorphone
• Other Study ID Numbers: NA_00093537; K23DA029609 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No