Study of the Treatment of Experimental Pain in Buprenorphine Maintained Persons With Chronic Musculoskeletal Pain
CompletedPhase 1NCT02372591
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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 details
- Official title
- Analgesic Effects and Abuse Liability of Intravenous Hydromorphone and Buprenorphine in Opioid Dependent Participants With Chronic Musculoskeletal Pain
- Conditions
- Interventions
- Drug: Buprenorphine
- Drug: Hydromorphone
- Drug: Placebo
- Sponsor
- Johns Hopkins University
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Start date
- 2015-08
- Primary completion
- 2017-06
- Sex
- All
- Age range
- from 18 Years to 55 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02372591