Characteristics of and Treatment Outcomes Among Patients With Prescription Narcotic Drug Use Disorder: a Naturalistic Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Johan Franck
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Change in prescription narcotic drug use
研究概览
简要总结
This study follows up patients who receive standard treatment for prescription narcotic drug use disorder, including opioids, benzodiazepines, and benzodiazepine-like drugs (z-drugs), at a specialized addiction service. The overall goal is to evaluate the proportion of patients who reduce or cease using prescription narcotics and the factors associated with treatment outcomes. No new treatments will be tested. Instead, the results will be used as the basis for a future randomized controlled trial to optimize treatment for narcotic drug use disorder.
详细描述
Background: The study covers prescription narcotics and focuses on opioids and benzodiazepines (and related compounds). The use of opioids and benzodiazepines is relatively safe in the short term. However, long-term use for anxiety and chronic non cancer pain has limited scientific support. Moreover, use of opioids and benzodiazepines has been associated with a variety of adverse effects and both opioids and benzodiazepines are highly addictive.
Clinical guidelines advise that narcotic analgesics and sedatives should not be used as first-choice treatments for pain, anxiety, or insomnia. Instead, guidelines recommend psychotherapy, physiotherapy, and non-narcotic pharmacological drugs (such as non-steroidal anti-inflammatory drugs and antidepressants), alternatives that are less addictive and more beneficial over time. Despite such recommendations, benzodiazepines and opioids are commonly prescribed and used over the long term.
For patients who seek treatment for narcotic drug use disorder, tapering by gradual dose reduction is an important component but its effect is not well studied.
Aims: This study aims to investigate the clinical trajectory and treatment outcome among patients with narcotic drug use disorder at specialized addiction treatment services.
Specific aims:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients seeking treatment for prescription narcotic drug use disorder (ICD-10: F111, F112, F131, and F132)
- •≥ 18 years
- •Willing to participate and who have provided written informed consent.
排除标准
- •Inability to understand spoken and written study information.
- •Having started tapering prior to the start of the study.
结局指标
主要结局
Change in prescription narcotic drug use
时间窗: 6-, 12- and 24-month follow-up or at last visit; 10-year follow-up.
Change in dosage of prescription narcotic drugs
次要结局
- Prescription narcotic drug abstinence(6-, 12- and 24-month follow-up or at last visit)
- Retention in treatment(6-, 12- and 24-month follow-up or at last visit)