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Enhancing Medication-based Analgesia in Humans

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02901275
Recruitment Status : Recruiting
First Posted : September 15, 2016
Last Update Posted : October 1, 2019
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
This research is being done to evaluate whether combining medications that are FDA approved but have not yet been approved for combination treatment, can be an effective way to reduce pain.

Condition or disease Intervention/treatment Phase
Pain Drug: Within-subject test of blinded study medications Phase 2

Detailed Description:
This study will systematically evaluate whether a combination of pharmacotherapies can effectively alleviate chronic pain. Subjects will complete a screening session before completing 5 study sessions that will occur once weekly. Subjects will double-blind doses of study medications the morning of each experimental session, and will undergo standardized pain testing, as well as provide self-report ratings of drug effects, and cognitive tests.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Enhancing Medication-based Analgesia in Humans
Actual Study Start Date : December 2016
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 5 outpatient sessions
This is a within-subject study so all session procedures will be identical, however the specific medications provided as part of the double-blinded study medications may change during each session. During each session, which will last up to 8 hours a day and will be conducted on an outpatient basis, participants will be asked to complete standardized pain testing procedures, as well as questionnaires about how they are feeling and to complete cognitive tasks.
Drug: Within-subject test of blinded study medications
This is a double-blind within-subject Phase II trial. As such, study medications must remain blinded. Participants may receive a dose of medication from one or more of the following categories: prescription stimulants, prescription benzodiazepines, prescription opioids, prescription cannabinoids, over-the-counter medications, or placebo (sugar pill). This study will use a within-subject design, and all participants will serve as their own control. Study medication administration will be randomized within each participant.

Primary Outcome Measures :
  1. Largest change from baseline on time spent in cold pressor [ Time Frame: 8-hour study session ]
    The study will measure whether blinded study medications change seconds (range 0 -120) with hand submerged in cold pressor test of laboratory-induced pain.

  2. Largest rating of "Drug Effect" (0-100) as measured by the Visual Analog Rating Scale [ Time Frame: 8-hour study session ]
    The study will measure whether blinded study medications are detected differently, as measured by Visual Analog Scale ratings of Drug Effect (0-100)

  3. Change in percent accuracy on Digit Symbol Substitution task relative to baseline [ Time Frame: 8-hour study session ]
    The study will measure whether blinded study medications change percent accuracy on the Digit Symbol Substitution Test of cognitive behavior, relative to baseline

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Not pregnant or breast feeding
  • Medically cleared to take blinded study medications
  • Willing to comply with study protocol

Exclusion Criteria:

  • Not experiencing and/or being treated for current pain
  • Lack of significant medical or psychiatric illness that would interfere with study participation or informed consent
  • Known allergy to the blinded study medications

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 identifier (NCT number): NCT02901275

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Contact: Kelly E Dunn, PhD 410-550-2254

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United States, Maryland
Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21224
Contact: Kelly E Dunn, PhD    410-550-9799   
Sponsors and Collaborators
Johns Hopkins University
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Principal Investigator: Kelly Dunn, PhD Principal Investigator
Principal Investigator: Claudia Campbell, PhD Principal Investigator

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Responsible Party: Johns Hopkins University Identifier: NCT02901275     History of Changes
Other Study ID Numbers: IRB00097937
First Posted: September 15, 2016    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Johns Hopkins University:
Clinical Trial, Phase II