Enhancing Medication-based Analgesia in Humans- STUDY 2
Study Details
Study Description
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 |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Area under the curve value of time spent in cold pressor area under the curve [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.
- Area under the curve value of "Drug Effect" (0-100), as measured by the Visual Analog Rating Scale [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)
- Area under the curve value of percent accuracy on Digit Symbol Substitution task [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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Not pregnant or breast feeding
-
Medically cleared to take blinded study medications
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Willing to comply with study protocol
Exclusion Criteria:
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Not experiencing and/or being treated for current pain
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Lack of significant medical or psychiatric illness that would interfere with study participation or informed consent
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Known allergy to the blinded study medications
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Johns Hopkins University Bayview Medical Campus | Baltimore | Maryland | United States | 21224 |
Sponsors and Collaborators
- Johns Hopkins University
- National Institute on Drug Abuse (NIDA)
Investigators
- Principal Investigator: Kelly E Dunn, PhD, Johns Hopkins University
- Principal Investigator: Claudia Campbell, PhD, Johns Hopkins University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB00214289
- R01DA040644