A CTSC Clinical Research Center Study: A Comparison of the Addiction Liability of Hydrocodone and Sustained Release Morphine
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 12
- 主要终点
- 3 Scores on the Addiction Research Center Inventory (ARCI)
研究概览
简要总结
Characterize the relative abuse liability of a short versus a long acting opioid in chronic pain patients.
详细描述
A placebo-controlled, double-blind, crossover trial will be conducted providing study subjects either hydrocodone/acetaminophen 30mg/975mg, sustained release morphine 45mg or placebo on separate GCRC visits. A long acting comparator (slow-release morphine sulfate 45 mg) will be chosen because of its putative equianalgesic effects to the dose of hydrocodone (30 mg) selected. Subjects will participate in the three sessions at the UC Davis/Mather Medical Center General Clinical Research Center (GCRC) at intervals of 7-10 days. Sessions will be approximately 360 min in duration. Subjects will receive either hydrocodone/acetaminophen or sustained release morphine around-the-clock for 7-10 days prior to the experimental session. At each experimental session, an assessment of abuse liability will be completed before the intake of medications, as well as at 0, 60, 120, 180, 240 minutes after the ingestion of the study medication.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with chronic pain for periods greater than 6 months
- •Patients taking greater than 80 mg morphine equivalents of a short acting opioid (>8 vicodin or 4 oxycodone/day)
- •Referral to Pain or Substance Abuse Clinic for self-escalation of opioids
排除标准
- •Inability to understand and comprehend spoken English
- •Patients with Munchausen's syndrome
- •Patient has a history of Peripheral Vascular Disease
- •Patient has a history of Raynaud's Phenomenon
- •Liver Disease; Child's classification greater than 1 (liver cirrhosis) will be excluded
- •Renal disease (BUN >25 or Cr >1.5)
- •Congestive Heart Failure; Subjects with New York Heart Association (NYHA)Heart Failure Symptom Classification System Level of Impairment II, III and IV will be excluded
- •Coronary artery disease; recent MI within the past six months or recent history of angina not controlled with NTG within the past six months
- •Hypertension; 1)previously normotensive subject; systolic bp >140 mm Hg and diastolic bp > 90 mm Hg 2) Hx of active treatment with antihypertensive medications; systolic bp >150 mm Hg and diastolic bp > 100 mm Hg
- •Cerebrovascular disease; recent history within the past year of a transient ischemic attack or recent history within the past year of a cerebrovascular event
- •Malignancy requiring active treatment
- •Patient is pregnant (as ascertained by a self-report and a mandatory commercial pregnancy test before any study medication is consumed)
研究组 & 干预措施
extended-release morphine
Markers of Abuse Liability, Neuropsych Testing, and Cue Reactivity
On one of three study dates, subjects received ER morphine tablets, 45 mg (Mallinckrodt Pharmaceuticals, St. Louis, MO). The dose of ER morphine sulfate (45 mg) was selected because of its approximate equianalgesic effect to the dose of hydrocodone-acetaminophen (30/925 mg).
干预措施: Markers of Abuse Liability, Neuropsych Testing, and Cue Reactivity (Behavioral)
extended-release morphine
Markers of Abuse Liability, Neuropsych Testing, and Cue Reactivity
On one of three study dates, subjects received ER morphine tablets, 45 mg (Mallinckrodt Pharmaceuticals, St. Louis, MO). The dose of ER morphine sulfate (45 mg) was selected because of its approximate equianalgesic effect to the dose of hydrocodone-acetaminophen (30/925 mg).
干预措施: ER Morphine (Drug)
hydrocodone
Markers of Abuse Liability, Neuropsych Testing, and Cue Reactivity
On the day of the study session, patients received hydrocodone 30 mg plus N-acetyl-para-aminophenol 975 mg (APAP;Qualitest Pharmaceuticals Inc, Huntsville, AL).
干预措施: Markers of Abuse Liability, Neuropsych Testing, and Cue Reactivity (Behavioral)
hydrocodone
Markers of Abuse Liability, Neuropsych Testing, and Cue Reactivity
On the day of the study session, patients received hydrocodone 30 mg plus N-acetyl-para-aminophenol 975 mg (APAP;Qualitest Pharmaceuticals Inc, Huntsville, AL).
干预措施: hydrocodone plus acetaminophen (Drug)
placebo
Subjects received a placebo pill if randomized to this arm. Both opioid medications and the placebo were administered in identical capsules.
干预措施: Markers of Abuse Liability, Neuropsych Testing, and Cue Reactivity (Behavioral)
placebo
Subjects received a placebo pill if randomized to this arm. Both opioid medications and the placebo were administered in identical capsules.
干预措施: placebo (Drug)
结局指标
主要结局
3 Scores on the Addiction Research Center Inventory (ARCI)
时间窗: 0, 60, 120, 180, 240, or 300 minutes
The subjective effects of the study drug were evaluated with 3 subscales of the Addiction Research Center Inventory (ARCI). The subscales studied included Morphine-Benzedrine Group which measured euphoria (0-16 with higher numbers indicating more euphoria), the Phenobarbital-Chorpromazine-Alcohol Group which measured sedation (-3 to +11 with higher scores indicating more sedation), and the Lysergic Acid Diethylmide Group which measured dysphoria and agitation (-4 to +10 with higher scores indicating more dysphoria). This inventory consists of 49 true/ false questions which survey major domains of drug effects. The ARCI was measured at six timepoints. Of interest were trough sedation, peak euphoria, and trough dysphoria.
次要结局
未报告次要终点