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Effects of Sleep Disruption on Drug Response

Primary Purpose

Low Back Pain, Recurrent, Healthy

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Within-Subject test of blinded study medication
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Low Back Pain, Recurrent

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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)
  • 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.

Sites / Locations

  • Johns Hopkins School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Uninterrupted Sleep

Sleep Disruption

Arm Description

Participants will be permitted to sleep without interruption for 8 hours.

Participants will be repeatedly awakened throughout the night according to a standardized protocol.

Outcomes

Primary Outcome Measures

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?"
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.
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."
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".

Secondary Outcome Measures

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?"
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?"
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?"
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?"
Clinical Pain
This will be rated on a 0-100 Numerical Rating Scale, where 0 = "No Pain" and 100 = "Worst Pain Imaginable."

Full Information

First Posted
August 27, 2018
Last Updated
January 12, 2023
Sponsor
Johns Hopkins University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT03680287
Brief Title
Effects of Sleep Disruption on Drug Response
Official Title
Effects of Sleep Disruption on Drug Response
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 7, 2019 (Actual)
Primary Completion Date
February 29, 2024 (Anticipated)
Study Completion Date
February 29, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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(*) and healthy controls (N = 60). (*) We originally aimed to accrue 60 subjects with CLBP. However, we have been granted approval by 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Recurrent, Healthy

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Uninterrupted Sleep
Arm Type
Active Comparator
Arm Description
Participants will be permitted to sleep without interruption for 8 hours.
Arm Title
Sleep Disruption
Arm Type
Experimental
Arm Description
Participants will be repeatedly awakened throughout the night according to a standardized protocol.
Intervention Type
Drug
Intervention Name(s)
Within-Subject test of blinded study medication
Intervention Description
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.
Primary Outcome Measure Information:
Title
Drug Liking as assessed by the Visual Analog Scale
Description
Visual Analog Scale (0-100), where 0=None and 100 = Extremely , in response to the question, "Do you like the drug?"
Time Frame
up to 420 minute post-medication administration
Title
Heat Pain Threshold
Description
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.
Time Frame
up to 420 minute post-medication administration
Title
Suprathreshold Tonic Heat Pain
Description
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."
Time Frame
up to 420 minute post-medication administration
Title
Monetary Valuation of Drug as assessed by the Drug vs. Money Multiple Choice Questionnaire
Description
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".
Time Frame
up to 420 minute post-medication administration
Secondary Outcome Measure Information:
Title
Good Drug Effects as assessed by the Visual Analog Scale
Description
Visual Analog Scale (0-100), where 0=None and 100 = Extremely , in response to the question, "Does the drug have any good effects?"
Time Frame
up to 420 minute post-medication administration
Title
Bad Drug Effects as assessed by the Visual Analog Scale
Description
Visual Analog Scale (0-100), where 0=None and 100 = Extremely , in response to the question, "Does the drug have any bad effects?"
Time Frame
up to 420 minute post-medication administration
Title
Level of "Highness" as assessed by Visual Analog Scale
Description
Visual Analog Scale (0-100), where 0=None and 100 = Extremely , in response to the question, "How high are you?"
Time Frame
up to 420 minute post-medication administration
Title
Feeling of Sickness as assessed by Visual Analog Scale
Description
Visual Analog Scale (0-100), where 0=None and 100 = Extremely , in response to the question, "Does this drug make you feel sick?"
Time Frame
up to 420 minute post-medication administration
Title
Clinical Pain
Description
This will be rated on a 0-100 Numerical Rating Scale, where 0 = "No Pain" and 100 = "Worst Pain Imaginable."
Time Frame
up to 420 minute post-medication administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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) 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael T. Smith, PhD
Phone
410-550-9059
Email
msmith62@jhmi.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael T. Smith, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael T Smith, Ph.D.
Phone
410-550-9059
Email
msmith62@jhmi.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Sleep Disruption on Drug Response

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