Clinical trial NCT03680287: Effects of Sleep Disruption on Drug Response
Official title: Effects of Sleep Disruption on Drug Response
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Low Back Pain, Recurrent
Healthy
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2018-09-21
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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 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.


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.

Primary outcomes:
measure: Drug Liking as assessed by the Visual Analog Scale
timeFrame: up to 420 minute post-medication administration
measure: Heat Pain Threshold
timeFrame: up to 420 minute post-medication administration
measure: Suprathreshold Tonic Heat Pain
timeFrame: up to 420 minute post-medication administration
measure: Monetary Valuation of Drug as assessed by the Drug vs. Money Multiple Choice Questionnaire
timeFrame: up to 420 minute post-medication administration
Secondary outcomes:
measure: Good Drug Effects as assessed by the Visual Analog Scale
timeFrame: up to 420 minute post-medication administration
measure: Bad Drug Effects as assessed by the Visual Analog Scale
timeFrame: up to 420 minute post-medication administration
measure: Level of "Highness" as assessed by Visual Analog Scale
timeFrame: up to 420 minute post-medication administration
measure: Feeling of Sickness as assessed by Visual Analog Scale
timeFrame: up to 420 minute post-medication administration
measure: Clinical Pain
timeFrame: up to 420 minute post-medication administration
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins School of Medicine
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Michael T. Smith, PhD
role: PRINCIPAL_INVESTIGATOR
References: