Impact of sleep disruption on medication response in back pain
Effects of Sleep Disruption on Drug Response
This study is testing how a night of poor sleep affects how well pain medication works for people with chronic low back pain compared to healthy individuals.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT03680287 on ClinicalTrials.gov |
What this trial studies
This study investigates how sleep disruption affects the subjective response to medication in individuals with chronic low back pain compared to healthy controls. It employs a mixed between-within randomized crossover design, where participants will receive blinded medication after one night of uninterrupted sleep and after one night of sleep disruption. The study focuses on two main outcomes: the potential for drug abuse and the response to standardized pain testing. The researchers aim to understand how these responses may differ based on the presence of chronic pain and the participant's sex.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-60 with a physician-confirmed diagnosis of chronic low back pain.
Not a fit: Patients with significant medical or psychiatric conditions, or a history of opioid use disorder, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies that consider the impact of sleep on medication efficacy.
How similar studies have performed: Other studies have shown that sleep can significantly impact pain perception and medication response, suggesting this approach is promising.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Baltimore, Maryland
- Johns Hopkins School of Medicine — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Michael T. Smith, PhD — Johns Hopkins University
- Study coordinator: Michael T. Smith, PhD
- Email: msmith62@jhmi.edu
- Phone: 410-550-9059
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.