Overview

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

Status:
Completed
Trial end date:
2017-06-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Johns Hopkins University
Collaborator:
National Institute on Drug Abuse (NIDA)
Treatments:
Buprenorphine
Hydromorphone
Criteria
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.