Study of the Treatment of Experimental Pain in Buprenorphine Maintained Persons With Chronic Musculoskeletal Pain
Information source: Johns Hopkins University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Opioid-Related Disorders; Chronic Pain
Intervention: Buprenorphine (Drug); Hydromorphone (Drug); Placebo (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Johns Hopkins University Official(s) and/or principal investigator(s): D. Andrew Tompkins, M.D. M.H.S., Principal Investigator, Affiliation: Johns Hopkins University
Overall contact: Jessica Harras, Phone: 410-550-9494, Email: jharras2@jhmi.edu
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.
Clinical Details
Official title: Analgesic Effects and Abuse Liability of Intravenous Hydromorphone and Buprenorphine in Opioid Dependent Participants With Chronic Musculoskeletal Pain
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Cold pressor testPressure pain Thermal pain Temporal summation Diffuse noxious inhibitory controls (DNIC)
Secondary outcome: Visual analog scales (VAS) of subjective drug effectsPupil diameter Number of participants with adverse events Profile of mood states (POMS) Vital signs Trait pain catastrophizing Money versus drug questionnaire End of session questionnaire
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
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 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.
Locations and Contacts
Jessica Harras, Phone: 410-550-9494, Email: jharras2@jhmi.edu
Behavioral Pharmacology Research Unit, Baltimore, Maryland 21224, United States; Recruiting Jessica Harras, Phone: 410-550-9494, Email: jharras2@jhmi.edu D. Andrew Tompkins, M.D., Principal Investigator
Additional Information
Starting date: August 2015
Last updated: August 11, 2015
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