Effects of Sleep Disruption on Drug Response

Johns Hopkins University

Status and phase: Completed; Phase 2

Conditions: Healthy; Low Back Pain, Recurrent

Treatments: Drug: Within-Subject test of blinded study medication

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03680287

IRB00160629

R01DA048206 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 109 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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109 participants in 2 patient groups

Uninterrupted Sleep

Active Comparator group

Description:

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

Treatment:

Drug: Within-Subject test of blinded study medication

Sleep Disruption

Experimental group

Description:

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

Treatment:

Drug: Within-Subject test of blinded study medication