Effects of Sleep Disruption on Drug Response

Effects of Sleep Disruption on Drug Response

Sponsors

Lead Sponsor: Johns Hopkins University

Collaborator: National Institute on Drug Abuse (NIDA)

Source Johns Hopkins University
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 (N = 60) and healthy controls (N = 60).

Overall Status Recruiting
Start Date October 7, 2019
Completion Date February 29, 2024
Primary Completion Date February 29, 2024
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Drug Liking as assessed by the Visual Analog Scale up to 420 minute post-medication administration
Heat Pain Threshold up to 420 minute post-medication administration
Suprathreshold Tonic Heat Pain up to 420 minute post-medication administration
Monetary Valuation of Drug as assessed by the Drug vs. Money Multiple Choice Questionnaire up to 420 minute post-medication administration
Secondary Outcome
Measure Time Frame
Good Drug Effects as assessed by the Visual Analog Scale up to 420 minute post-medication administration
Bad Drug Effects as assessed by the Visual Analog Scale up to 420 minute post-medication administration
Level of "Highness" as assessed by Visual Analog Scale up to 420 minute post-medication administration
Feeling of Sickness as assessed by Visual Analog Scale up to 420 minute post-medication administration
Clinical Pain up to 420 minute post-medication administration
Enrollment 250
Condition
Intervention

Intervention Type: Drug

Intervention Name: Within-Subject test of blinded study medication

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.

Eligibility

Criteria:

Inclusion Criteria:

General Inclusion Criteria:

- 21-60 years old

- A stable sleep phase within 21:00 and 09:00

- Total sleep time >6 and <8.5 hours/night

- Sleep efficiency >80%

- 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 >35

- Significant medical or psychiatric morbidity within 6 months or lifetime history of bipolar disorder, psychotic disorder, seizure disorder

- Lifetime history of alcohol or substance use disorder including 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.

Gender: All

Minimum Age: 21 Years

Maximum Age: 60 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Patrick H. Finan, PhD Principal Investigator Johns Hopkins University
Overall Contact

Last Name: Patrick H. Finan, PhD

Phone: 410-550-7901

Email: [email protected]

Location
Facility: Status: Contact: Johns Hopkins School of Medicine Patrick Finan, Ph.D. 410-550-7901 [email protected]
Location Countries

United States

Verification Date

January 2020

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Uninterrupted Sleep

Type: Active Comparator

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

Label: Sleep Disruption

Type: Experimental

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

Patient Data No
Study Design Info

Allocation: Non-Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Basic Science

Masking: Triple (Participant, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov