Study of the Treatment of Experimental Pain in Buprenorphine Maintained Persons With Chronic Musculoskeletal Pain
| Status: | Recruiting |
|---|---|
| Conditions: | Chronic Pain, Chronic Pain, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 4/21/2016 |
| Start Date: | August 2015 |
| End Date: | May 2017 |
| Contact: | Jessica Harras |
| Email: | jharras2@jhmi.edu |
| Phone: | 410-550-9494 |
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.
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.
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.
We found this trial at
1
site
Baltimore, Maryland 21224
Principal Investigator: D. Andrew Tompkins, M.D.
Phone: 410-550-9494
Click here to add this to my saved trials
