Effects of Sleep Disruption on Drug Response
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 1
- 主要终点
- Drug Liking as assessed by the Visual Analog Scale
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •General Exclusion Criteria:
- •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.
研究组 & 干预措施
Uninterrupted Sleep
Participants will be permitted to sleep without interruption for 8 hours.
干预措施: Within-Subject test of blinded study medication (Drug)
Sleep Disruption
Participants will be repeatedly awakened throughout the night according to a standardized protocol.
干预措施: Within-Subject test of blinded study medication (Drug)
结局指标
主要结局
Drug Liking as assessed by the Visual Analog Scale
时间窗: up to 420 minute post-medication administration
Visual Analog Scale (0-100), where 0=None and 100 = Extremely , in response to the question, "Do you like the drug?"
Heat Pain Threshold
时间窗: up to 420 minute post-medication administration
A thermode will gradually increase in temperature until the participant indicates when it "first feels painful". The outcome will be the temperature (degrees Celsius) at which the participant indicates they first feel pain.
Suprathreshold Tonic Heat Pain
时间窗: up to 420 minute post-medication administration
A painful temperature above threshold will be held tonically for a period of time, after which pain ratings are obtained on a 0-100 numerical rating scale, where 0 = "No Pain" and 100 = "Worst Pain Imaginable."
Monetary Valuation of Drug as assessed by the Drug vs. Money Multiple Choice Questionnaire
时间窗: up to 420 minute post-medication administration
Participants are presented with an array of choices (in dollar value) which they will compare to the option of receiving study drug. They will decide for each choice whether they would take the money (at that value) or the drug they received in the session. The outcome will be the "crossover point", which is the mean of the last price that the participant selected "drug" and the first price at which the participant selected "money".
次要结局
- Bad Drug Effects as assessed by the 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)
- Good Drug Effects as assessed by the Visual Analog Scale(up to 420 minute post-medication administration)
- Clinical Pain(up to 420 minute post-medication administration)
- Level of "Highness" as assessed by Visual Analog Scale(up to 420 minute post-medication administration)