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Trial record 26 of 55 for:    Recruiting, Not yet recruiting, Available Studies | NOT (Use Disorders OR Marijuana Use OR Dependence OR Abuse OR Drug Use) | cannabinoids

Enhancing Medication-based Analgesia in Humans- STUDY 2

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ClinicalTrials.gov Identifier: NCT04036968
Recruitment Status : Not yet recruiting
First Posted : July 30, 2019
Last Update Posted : July 30, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
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. This is study 2 is a series of studies.

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 : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Within-subject study
Masking: None (Open Label)
Masking Description: Study drug administration will be concealed from all study staff and participants to prevent bias in outcomes.
Primary Purpose: Basic Science
Official Title: Enhancing Medication-based Analgesia in Humans- STUDY 2
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

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 participants 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 participants' own control. Study medication administration will be randomized within each participant.




Primary Outcome Measures :
  1. Area under the curve value of time spent in cold pressor area under the curve [ 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. Area under the curve value 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. Area under the curve value of percent accuracy on Digit Symbol Substitution task [ 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



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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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT04036968


Contacts
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Contact: Kelly E Dunn, PhD 410-550-2254 kdunn9@jhmi.edu

Locations
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United States, Maryland
Johns Hopkins University Bayview Medical Campus Not yet recruiting
Baltimore, Maryland, United States, 21224
Contact: Kelly E Dunn, PhD    410-550-2254    kdunn9@jhmi.edu   
Sponsors and Collaborators
Johns Hopkins University
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Kelly E Dunn, PhD Johns Hopkins University
Principal Investigator: Claudia Campbell, PhD Johns Hopkins University

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT04036968     History of Changes
Other Study ID Numbers: IRB00214289
R01DA040644 ( U.S. NIH Grant/Contract )
First Posted: July 30, 2019    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Johns Hopkins University:
Clinical Trial
Analgesia
Phase II