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Effects of Sleep Disruption on Drug Response

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ClinicalTrials.gov Identifier: NCT03680287
Recruitment Status : Recruiting
First Posted : September 21, 2018
Last Update Posted : January 13, 2020
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Johns Hopkins University

Study Description
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Brief 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. 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 (N = 60) and healthy controls (N = 60).


Condition or disease Intervention/treatment Phase
Low Back Pain, Recurrent Healthy Drug: Within-Subject test of blinded study medication Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effects of Sleep Disruption on Drug Response
Actual Study Start Date : October 7, 2019
Estimated Primary Completion Date : February 29, 2024
Estimated Study Completion Date : February 29, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Uninterrupted Sleep
Participants will be permitted to sleep without interruption for 8 hours.
 Drug: Within-Subject test of blinded study medication
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.
Experimental: Sleep Disruption
Participants will be repeatedly awakened throughout the night according to a standardized protocol.
 Drug: Within-Subject test of blinded study medication
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.


Outcome Measures
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Primary Outcome Measures :
  1. Drug Liking as assessed by the Visual Analog Scale [ Time Frame: up to 420 minute post-medication administration ]
    Visual Analog Scale (0-100), where 0=None and 100 = Extremely , in response to the question, "Do you like the drug?"

  2. Heat Pain Threshold [ Time Frame: up to 420 minute post-medication administration ]
    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.

  3. Suprathreshold Tonic Heat Pain [ Time Frame: up to 420 minute post-medication administration ]
    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."

  4. Monetary Valuation of Drug as assessed by the Drug vs. Money Multiple Choice Questionnaire [ Time Frame: up to 420 minute post-medication administration ]
    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".


Secondary Outcome Measures :
  1. Good Drug Effects as assessed by the Visual Analog Scale [ Time Frame: up to 420 minute post-medication administration ]
    Visual Analog Scale (0-100), where 0=None and 100 = Extremely , in response to the question, "Does the drug have any good effects?"

  2. Bad Drug Effects as assessed by the Visual Analog Scale [ Time Frame: up to 420 minute post-medication administration ]
    Visual Analog Scale (0-100), where 0=None and 100 = Extremely , in response to the question, "Does the drug have any bad effects?"

  3. Level of "Highness" as assessed by Visual Analog Scale [ Time Frame: up to 420 minute post-medication administration ]
    Visual Analog Scale (0-100), where 0=None and 100 = Extremely , in response to the question, "How high are you?"

  4. Feeling of Sickness as assessed by Visual Analog Scale [ Time Frame: up to 420 minute post-medication administration ]
    Visual Analog Scale (0-100), where 0=None and 100 = Extremely , in response to the question, "Does this drug make you feel sick?"

  5. Clinical Pain [ Time Frame: up to 420 minute post-medication administration ]
    This will be rated on a 0-100 Numerical Rating Scale, where 0 = "No Pain" and 100 = "Worst Pain Imaginable."


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

General Inclusion Criteria:

  • 21-60 years old
  • A stable sleep phase within 21:00 and 09:00
  • Total sleep time >6 and <8.5 hours/night
  • Sleep efficiency >80%
  • 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.

Exclusion Criteria:

General Exclusion Criteria:

  • BMI >35
  • Significant medical or psychiatric morbidity within 6 months or lifetime history of bipolar disorder, psychotic disorder, seizure disorder
  • Lifetime history of alcohol or substance use disorder including 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)
  • 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.
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT03680287


Contacts
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Contact: Patrick H. Finan, PhD 410-550-7901 pfinan1@jhu.edu

Locations
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United States, Maryland
Johns Hopkins School of Medicine Recruiting
Baltimore, Maryland, United States, 21224
Contact: Patrick Finan, Ph.D.    410-550-7901    pfinan1@jhu.edu   
Sponsors and Collaborators
Johns Hopkins University
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Patrick H. Finan, PhD Johns Hopkins University
More Information
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03680287    
Other Study ID Numbers: IRB00160629
R01DA048206 ( U.S. NIH Grant/Contract )
First Posted: September 21, 2018    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020
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
Additional relevant MeSH terms:
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Low Back Pain
Back Pain
Pain
Neurologic Manifestations