Low Back Pain, RecurrentPhase 2NCT03680287
Effects of Sleep Disruption on Drug Response
A Phase 2 study testing Within-Subject test of blinded study medication in people with Low Back Pain, Recurrent and Healthy, run by Johns Hopkins University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain, Recurrent, Healthy
- What is being tested?
- Within-Subject test of blinded study medication
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2019to 29 Apr 2025
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- General Inclusion Criteria:
- 18-60 years old
- Less than 2 servings/day of caffeinated beverages and willing to discontinue 3 days prior to admission.
- CLBP-Specific Inclusion Criteria:
- Have a physician-confirmed diagnosis of CLBP
- Report chronic low back pain.
Who cannot join
- General Exclusion Criteria:
- BMI >40
- Significant medical or psychiatric morbidity within 6 months or lifetime history of bipolar disorder, psychotic disorder, seizure disorder
- Lifetime history of opioid use disorder
- Clinically significant abnormal complete blood count or comprehensive metabolic profile
- Any contraindicated medical condition (status asthmaticus; chronic obstructive pulmonary disease; reduced respiratory function; hypotension; hypertension; impairment of hepatic, pulmonary or renal functions; myxedema or hyperthyroidism; adrenocortical insufficiency; gastrointestinal obstruction; gall bladder disease; acute alcoholism; history of convulsive disorders; history of head injury)
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- Current use of stimulants, opioids, benzodiazepines or other Central Nervous System (CNS) depressant
- Positive toxicology screen for opioids, stimulants, or recreational drugs
- Pregnancy or lactation
- Significant preadmission psychological distress.
- Healthy Control and CLBP-Specific Exclusion Criteria:
- Report current medical/psychiatry history
- Report acute painful injury (within 3 months)
- Have a diagnosed chronic pain disorder.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins School of Medicine
Baltimore, Maryland, 21224
About this study
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.
Read more
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.
- Conditions
- Low Back Pain, Recurrent, Healthy
- Being tested
- Within-Subject test of blinded study medication
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Within-Subject test of blinded study medicationDrug
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. Participants receive up to four injections, starting with placebo (saline). This is followed by ascending doses of Hydromorphone (0.14, 0.28, and 0.56mg/70kg). This study uses a within-subject design, such that participants serve as participants' own control.
| Study group | Role | What they receive |
|---|---|---|
| Uninterrupted Sleep | Active comparator | Participants will be permitted to sleep without interruption for 8 hours. Receives: Drug: Within-Subject test of blinded study medication |
| Sleep Disruption | Experimental | Participants will be repeatedly awakened throughout the night according to a standardized protocol. Receives: Drug: Within-Subject test of blinded study medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?" Values reported represent average values across time points in the drug administration assessment period (up to 420 minutes).
Measured: 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. Values reported represent average values across time points in the drug administration assessment period (up to 420 minutes).
Measured: 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." Values reported represent average values across time points in the drug administration assessment period (up to 420 minutes).
Measured: 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". Values reported represent those from a single administration following the drug administration assessment period.
Measured: up to 420 minute post-medication administration
Secondary outcomes (5)
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?" Values reported represent average values across time points in the drug administration assessment period (up to 420 minutes).
Measured: up to 420 minute post-medication administration
Bad 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 bad effects?" Values reported represent average values across time points in the drug administration assessment period (up to 420 minutes).
Measured: 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?" Values reported represent average values across time points in the drug administration assessment period (up to 420 minutes).
Measured: 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?" Values reported represent average values across time points in the drug administration assessment period (up to 420 minutes).
Measured: 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." Values reported represent average values across time points in the drug administration assessment period (up to 420 minutes).
Measured: up to 420 minute post-medication administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2018
- Study start7 Oct 2019
- Primary completion29 Apr 2025
- Study completion29 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Low Back Pain, RecurrentStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Michael T. Smith, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03680287
- Sponsor's protocol ID
- IRB00160629
- Other IDs
- R01DA048206
- Status last verified
- Sep 2026
- First submitted
- 27 Aug 2018
- Last updated
- 21 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No