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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA048206 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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The central scientific premise of the proposed study is that sleep disruption (SD) will influence individuals' subjective response to blinded medication administration. The investigators further believe these responses will vary among patients who have chronic low back pain (CLBP) vs. healthy controls, and that sex will moderate effects.
The proposed study evaluates whether CLBP patients' subjective responses to study medication administration are altered by SD. The investigators focus on two outcome domains: abuse liability (i.e., drug liking and valuation) and response to pain testing.
The investigators propose a mixed between-within randomized crossover human-laboratory experiment that investigates placebo-controlled effects of study medication on 1) abuse liability metrics (Drug Liking and Monetary Valuation) and 2) response to laboratory-evoked standardized pain measures, after one night of uninterrupted sleep (US) and again after one night of SD. The investigators will recruit both CLBP patients(*) and healthy controls (N = 60).
(*) We originally aimed to accrue 60 subjects with CLBP. However, we have been granted approval by the National Institute on Drug Abuse (NIDA) to reduce expectations for the target N for the CLBP cohort. We are no longer expected to recruit N=60 CLBP participants; this is a COVID-19 modification, and we are not required to re-do a power analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Uninterrupted Sleep | Active Comparator | Participants will be permitted to sleep without interruption for 8 hours. |
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| Sleep Disruption | Experimental | Participants will be repeatedly awakened throughout the night according to a standardized protocol. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Within-Subject test of blinded study medication | Drug | On the day after each sleep condition (Uninterrupted Sleep and Sleep Disruption), participants will undergo multiple injections of study medication or placebo. This is a double-blind within-subject Phase II trial. As such, study medications must remain blinded. Participants may receive a medication from one or more of the following categories: prescription stimulants, prescription benzodiazepines, prescription opioids, prescription cannabinoids, over-the-counter medications, or placebo (saline). This study uses a within-subject design, such that participants serve as participants' own control. |
| Measure | Description | Time Frame |
|---|---|---|
| Drug Liking as assessed by the Visual Analog Scale | Visual Analog Scale (0-100), where 0=None and 100 = Extremely , in response to the question, "Do you like the drug?" | up to 420 minute post-medication administration |
| Heat Pain Threshold | A thermode will gradually increase in temperature until the participant indicates when it "first feels painful". The outcome will be the temperature (degrees Celsius) at which the participant indicates they first feel pain. | up to 420 minute post-medication administration |
| Suprathreshold Tonic Heat Pain | A painful temperature above threshold will be held tonically for a period of time, after which pain ratings are obtained on a 0-100 numerical rating scale, where 0 = "No Pain" and 100 = "Worst Pain Imaginable." | up to 420 minute post-medication administration |
| Monetary Valuation of Drug as assessed by the Drug vs. Money Multiple Choice Questionnaire | Participants are presented with an array of choices (in dollar value) which they will compare to the option of receiving study drug. They will decide for each choice whether they would take the money (at that value) or the drug they received in the session. The outcome will be the "crossover point", which is the mean of the last price that the participant selected "drug" and the first price at which the participant selected "money". | up to 420 minute post-medication administration |
| Measure | Description | Time Frame |
|---|---|---|
| Good Drug Effects as assessed by the Visual Analog Scale | Visual Analog Scale (0-100), where 0=None and 100 = Extremely , in response to the question, "Does the drug have any good effects?" | up to 420 minute post-medication administration |
| Bad Drug Effects as assessed by the Visual Analog Scale |
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Inclusion Criteria:
General Inclusion Criteria:
CLBP-Specific Inclusion Criteria:
Exclusion Criteria:
General Exclusion Criteria:
Healthy Control and CLBP-Specific Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael T. Smith, PhD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins School of Medicine | Baltimore | Maryland | 21224 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 28, 2026 | May 21, 2026 | 12 | ||
| Jun 29, 2026 |
| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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|
Visual Analog Scale (0-100), where 0=None and 100 = Extremely , in response to the question, "Does the drug have any bad effects?" |
| up to 420 minute post-medication administration |
| Level of "Highness" as assessed by Visual Analog Scale | Visual Analog Scale (0-100), where 0=None and 100 = Extremely , in response to the question, "How high are you?" | up to 420 minute post-medication administration |
| Feeling of Sickness as assessed by Visual Analog Scale | Visual Analog Scale (0-100), where 0=None and 100 = Extremely , in response to the question, "Does this drug make you feel sick?" | up to 420 minute post-medication administration |
| Clinical Pain | This will be rated on a 0-100 Numerical Rating Scale, where 0 = "No Pain" and 100 = "Worst Pain Imaginable." | up to 420 minute post-medication administration |
| D013568 |
| Pathological Conditions, Signs and Symptoms |