Enhancing Medication-based Analgesia in Humans
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|ClinicalTrials.gov Identifier: NCT02901275|
Recruitment Status : Recruiting
First Posted : September 15, 2016
Last Update Posted : October 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pain||Drug: Within-subject test of blinded study medications||Phase 2|
|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|
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.
- 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.
- 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)
- 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
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): NCT02901275
|Contact: Kelly E Dunn, PhDfirstname.lastname@example.org|
|United States, Maryland|
|Johns Hopkins University||Recruiting|
|Baltimore, Maryland, United States, 21224|
|Contact: Kelly E Dunn, PhD 410-550-9799 email@example.com|
|Principal Investigator:||Kelly Dunn, PhD||Principal Investigator|
|Principal Investigator:||Claudia Campbell, PhD||Principal Investigator|