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

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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

Tracking Information
First Submitted Date  ICMJE February 20, 2015
First Posted Date  ICMJE February 26, 2015
Last Update Posted Date September 11, 2017
Study Start Date  ICMJE August 2015
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 7, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 20, 2015)
  • 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.
  • Pressure pain [ Time Frame: This will be measured 7 times during each 40-hour session. On average, all sessions will be completed within 4 weeks. ]
    An electronic algometer (Somedic; Horby, Sweden) with a 1cm2 hard rubber probe will be used to assess responses to noxious mechanical pressure on the trapezius and forearm. Pressure is gradually increased at a constant rate (30kPA/sec); the average threshold and tolerance across 2 trials will be calculated.
  • Thermal pain [ Time Frame: This will be measured 7 times during each 40-hour session. On average, all sessions will be completed within 4 weeks. ]
    All contact heat stimuli will be delivered using the FDA approved Medoc thermal stimulator (Ramat Yishai, Israel) on the dorsal forearm or dorsum of the foot. The thermode's temperature gradually increases (0.5oC/sec) until no longer tolerated (max 51 degrees Celsius). The average threshold and tolerance across 2 trials will be calculated.
  • Temporal summation [ Time Frame: This will be measured 7 times during each 40-hour session. On average, all sessions will be completed within 4 weeks. ]
    Temporal summation involves rapidly applying a series of identical noxious stimuli in the same area to determine the increase in pain across trials. For temporal summation of mechanical pain, pain ratings in response to a single punctuate noxious stimulus will be compared to pain ratings in response to a sequence of identical punctuate noxious stimuli. A weighted pinprick stimulator with a flat contact area of 0.2 mm diameter and a force of 256 mN will be used to deliver, to the dorsal surface of the hand, either a single pinprick stimulus or a train of 10 pinprick stimuli repeated at a 1/s rate.
  • Diffuse noxious inhibitory controls (DNIC) [ Time Frame: This will be measured 7 times during each 40-hour session. On average, all sessions will be completed within 4 weeks. ]
    DNIC refers to the phenomenon of one noxious stimulus inhibiting the pain of a second noxious stimulus. Baseline responses to a brief painful stimulus (e.g., algometer on right trapezius) are evaluated and then re-assessed during application of a tonic noxious stimulus (e.g., cold pressor test with left hand).
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: February 20, 2015)
  • Visual analog scales (VAS) of subjective drug effects [ Time Frame: This will be measured 7 times during each 40-hour session. On average, all sessions will be completed within 4 weeks. ]
    VAS are single item questions that assessed subjective drug effects at the time of scale completion. Ratings are entered into a computer by the participant positioning an arrow along a 100 mm line marked at either end with "none" (0) and "extremely" (100).
  • Pupil diameter [ Time Frame: This will be measured 13 times during each 40-hour session. On average, all sessions will be completed within 4 weeks. ]
    This will be assessed with a digital pupillometer (Neuroptics, Inc.) in constant room lighting.
  • Number of participants with adverse events [ Time Frame: This will be measured 7 times during each 40-hour session. On average, all sessions will be completed within 4 weeks. ]
  • Profile of mood states (POMS) [ Time Frame: This will be measured 7 times during each 40-hour session. On average, all sessions will be completed within 4 weeks. ]
    This scale consists of 72 adjectives commonly used to describe momentary mood states. Participants rate from 0 (not at all) to 5 (extremely).
  • Vital signs [ Time Frame: This will be measured at baseline and every 15 minutes during experimental pain testing. Testing will occur during 10 hours of each 40-hour session. Sessions will be separated by at least 7 days. ]
    These include blood pressure, pulse, respiration rate, and oxygen saturation.
  • Trait pain catastrophizing [ Time Frame: This will be measured once during the screening visit. ]
    Pain catastrophizing scale (PCS) will be administered at screening to measure trait levels of catastrophizing.
  • Money versus drug questionnaire [ Time Frame: This question will be asked once at the end of the session and again on the following day. ]
    Participants will be asked to indicate on a sliding scale a monetary value above which they would prefer money and below which they would prefer the drug they received during the experimental session.
  • End of session questionnaire [ Time Frame: This question will be asked once at the end of the session and again on the following day. ]
    the participants will be asked to reflect on their experience and answer a series of questions on the subjective effects of the study drug, the degree to which they would take the drug again, and to estimate the amount of money the drug effect would be worth on the street.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of the Treatment of Experimental Pain in Buprenorphine Maintained Persons With Chronic Musculoskeletal Pain
Official Title  ICMJE Analgesic Effects and Abuse Liability of Intravenous Hydromorphone and Buprenorphine in Opioid Dependent Participants With Chronic Musculoskeletal Pain
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Opioid-Related Disorders
  • Chronic Pain
Intervention  ICMJE
  • 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
  • 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
  • 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
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Active Comparator: Hydromorphone
    Intervention: Drug: Hydromorphone
  • Experimental: Buprenorphine
    Intervention: Drug: Buprenorphine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 7, 2017)
14
Original Estimated Enrollment  ICMJE
 (submitted: February 20, 2015)
42
Actual Study Completion Date  ICMJE June 2017
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02372591
Other Study ID Numbers  ICMJE NA_00093537
K23DA029609 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: D. Andrew Tompkins, M.D. M.H.S. Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP