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Study of the Treatment of Experimental Pain in Buprenorphine Maintained Persons With Chronic Musculoskeletal Pain (1401)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02372591
Recruitment Status : Completed
First Posted : February 26, 2015
Last Update Posted : September 11, 2017
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Johns Hopkins University

Brief 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.

Condition or disease Intervention/treatment Phase
Opioid-Related Disorders Chronic Pain Drug: Buprenorphine Drug: Hydromorphone Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Analgesic Effects and Abuse Liability of Intravenous Hydromorphone and Buprenorphine in Opioid Dependent Participants With Chronic Musculoskeletal Pain
Study Start Date : August 2015
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
Intravenous injection of approximately 10 mL administered via slow push over 5 minutes. Given 4 injections during the session with each injection separated by 1.5 hours.
Other Name: Normal Saline

Active Comparator: Hydromorphone Drug: Hydromorphone
Intravenous injection of approximately 10 mL administered via slow push over 5 minutes. Given 4 injections during the session with each injection separated by 1.5 hours.
Other Name: Dilaudid

Experimental: Buprenorphine Drug: Buprenorphine
Intravenous injection of approximately 10 mL administered via slow push over 5 minutes. Given 4 injections during the session with each injection separated by 1.5 hours.
Other Names:
  • Suboxone
  • Subutex




Primary Outcome Measures :
  1. Cold pressor test [ Time Frame: This will be measured 7 times during each 40-hour session. On average, all sessions will be completed within 4 weeks. ]
    The participant places a hand up to the wrist in a circulating water bath maintained at approximately 4 degrees Celsius (up to 5 minutes). The time at which pain develops is the threshold. The time a volunteer's hand remains underwater before pain is unbearable is tolerance.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02372591


Locations
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United States, Maryland
Behavioral Pharmacology Research Unit
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: D. Andrew Tompkins, M.D. M.H.S. Johns Hopkins University
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02372591    
Other Study ID Numbers: NA_00093537
K23DA029609 ( U.S. NIH Grant/Contract )
First Posted: February 26, 2015    Key Record Dates
Last Update Posted: September 11, 2017
Last Verified: September 2017
Keywords provided by Johns Hopkins University:
Quantitative Sensory Testing
Hydromorphone
Buprenorphine
Additional relevant MeSH terms:
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Musculoskeletal Pain
Chronic Pain
Opioid-Related Disorders
Pain
Neurologic Manifestations
Muscular Diseases
Musculoskeletal Diseases
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Buprenorphine
Hydromorphone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists