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Sleep Disruption's Impact on Medication Efficacy for Lower Back Pain

Phase 2
Recruiting
Led By Patrick H. Finan, PhD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
CLBP-Specific Inclusion Criteria: Report chronic low back pain
Have a physician-confirmed diagnosis of CLBP
Must not have
General Exclusion Criteria: 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)
Healthy Control and CLBP-Specific Exclusion Criteria: Have a diagnosed chronic pain disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 420 minute post-medication administration
Awards & highlights
No Placebo-Only Group

Summary

This trial will study the effects of sleep disruption on CLBP patients' and healthy controls' subjective responses to study medication administration, with a focus on two outcome domains: abuse liability and response to pain testing.

Who is the study for?
This trial is for adults aged 18-60, both healthy and those with chronic low back pain (CLBP), who consume less than two caffeinated drinks daily. Participants must not be pregnant or breastfeeding, have significant psychological distress, a recent painful injury, other chronic pain disorders, severe medical conditions, or a history of opioid use disorder.
What is being tested?
The study tests how sleep disruption affects responses to medication in terms of potential abuse and pain relief. It's a mixed between-within randomized crossover experiment comparing the effects after normal sleep versus disrupted sleep on drug liking and valuation as well as response to standardized pain measures.
What are the potential side effects?
Since the specific study medication is blinded (unknown), side effects are not detailed here. However, participants will be monitored for any adverse reactions related to the medication under both normal and disrupted sleep conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have chronic low back pain.
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My doctor has diagnosed me with chronic lower back pain.
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I am between 18 and 60 years old.
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I am between 18 and 60 years old.
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I have been diagnosed with chronic lower back pain by a doctor.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have severe asthma, lung, liver, kidney problems, thyroid issues, adrenal gland issues, stomach blockage, gallbladder disease, severe alcoholism, a history of seizures or head injuries.
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I do not have a diagnosed chronic pain disorder.
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I have not had serious health or mental health issues in the last 6 months and do not have a history of bipolar, psychosis, or seizures.
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I am not currently using stimulants, opioids, benzodiazepines, or other CNS depressants.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 420 minute post-medication administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 420 minute post-medication administration for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Drug Liking as assessed by the Visual Analog Scale
Heat Pain Threshold
Monetary Valuation of Drug as assessed by the Drug vs. Money Multiple Choice Questionnaire
+1 more
Secondary study objectives
Bad Drug Effects as assessed by the Visual Analog Scale
Clinical Pain
Feeling of Sickness as assessed by Visual Analog Scale
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Sleep DisruptionExperimental Treatment1 Intervention
Participants will be repeatedly awakened throughout the night according to a standardized protocol.
Group II: Uninterrupted SleepActive Control1 Intervention
Participants will be permitted to sleep without interruption for 8 hours.

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,587 Previous Clinical Trials
3,328,298 Total Patients Enrolled
Johns Hopkins UniversityLead Sponsor
2,327 Previous Clinical Trials
14,874,560 Total Patients Enrolled
Patrick H. Finan, PhDPrincipal InvestigatorJohns Hopkins University

Media Library

Effects of Sleep Disruption (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03680287 — Phase 2
Healthy Subjects Research Study Groups: Uninterrupted Sleep, Sleep Disruption
Healthy Subjects Clinical Trial 2023: Effects of Sleep Disruption Highlights & Side Effects. Trial Name: NCT03680287 — Phase 2
Effects of Sleep Disruption (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03680287 — Phase 2
~19 spots leftby Apr 2025
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