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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


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 test

Pressure pain

Thermal pain

Temporal summation

Diffuse noxious inhibitory controls (DNIC)

Secondary outcome:

Visual analog scales (VAS) of subjective drug effects

Pupil 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


Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.


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

Page last updated: August 23, 2015

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