The Norwegian Addiction, Pain and Trauma Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,650
- 试验地点
- 4
- 主要终点
- Chronic pain (ICD-10)
研究概览
简要总结
In populations with substance use disorders (SUD), there is a high prevalence of chronic pain with various underlying causes. Chronic pain can complicate the treatment of SUD and lead to poorer treatment outcomes. There is a need for a better understanding of the connections and interactions between chronic pain and substance use and dependence.
Further, there is a high prevalence of chronic pain among patients with post-traumatic stress disorder (PTSD). As there is an overlap between populations with SUD and PTSD, taking potentially traumatizing life-experiences and post-traumatic stress symptoms into account can provide a better understanding of chronic pain in populations with SUD.
The Nor-APT study is a cross-sectional study, recruiting from outpatient and inpatient substance use treatment centres connected to four hospitals. Participants complete a questionnaire about substance/medication use, pain and how pain affect function, stressful life events and post-traumatic stress symptoms. Patients can consent to self-reported data being linked to retrospective and prospective longitudinal data from national demographic and health registries.
The purpose of the study is to contribute to a better understanding and treatment of chronic pain among people with substance use disorders (SUD), and to contribute to the understanding of co-occurring substance use, chronic pain and post-traumatic stress symptoms.
The over-arching research aims are to:
I. Describe the prevalence and characteristics of pain for people in need of treatment for substance/medication use/dependence.
II. Describe how the pain affects physical and emotional functioning, and subjective quality of life.
III. Explore any connections between substance/medication use and pain, both what came first and any ways substance/medication use and pain affect each other.
IV. Explore the connection between chronic pain, potentially traumatizing life events and post-traumatic stress symptoms.
V. Explore how treatments received and how treatment affects outcomes.
In addition, we will explore whether participants' experiences can be categorized into typical trajectories for how substance use, chronic pain and stressful life events occur and develop over the life span.
详细描述
INTRODUCTION
Chronic pain and substance use
The prevalence of chronic pain is high among persons with opioid dependence and alcohol dependence. According to a recent review, it is common for patients to use both opioids and alcohol, and this is seen especially in cases where the patient also experiences chronic pain. Nevertheless, alcohol use is often omitted from research on opioids and chronic pain. The review concludes that there is a great need for more knowledge about co-use of alcohol and opioids in people with chronic pain.
The high prevalence of chronic pain in populations with opioid or alcohol dependence could be related to comorbid physical illness and injuries, which is prevalent among opioid dependent patients. It is also possible that use of opioids or alcohol can contribute to pain sensitivity and worsening of pain over time.
There have been few studies focusing on chronic pain and dependence on other substances than opioids or alcohol. The prevalence of chronic pain among people with, for example, amphetamine dependence or cannabis dependence has received little attention, although cannabinoids are also used as prescription painkillers.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
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
- •Patient in substance use treatment at a treatment centre under Akershus University Hospital, Oslo University Hospital, Vestfold Hospital or Telemark Hospital.
排除标准
- •Staff considers the patient to be unable to give informed consent/valid responses on the questionnaire OR staff considers participation to be too stressful/burdensome to the patient. Staff are asked to take the following into consideration when making their assessment:
- •Acute withdrawal
- •Acute intoxication
- •Serious mental health concerns
- •Serious physical health concerns
结局指标
主要结局
Chronic pain (ICD-10)
时间窗: T1 (at enrollment in study)
Defined as having experienced pain with a duration of at least 3 months.
European-Addiction Severity Index (EuropASI), Section E
时间窗: T1 (at enrollment in study)
* Types of substances used (life-time), age of first use, and frequency of use in the last 4 weeks. * Intravenous use (life-time and last 4 weeks) Modifications: 1. We updated the list of substances to better match the relevant substances in use today: Alcohol to intoxication; OMT medications (methadone; subutex; suboxone); Other opioid painkillers (e.g. morphine, oxycodone, tramadol); Cannabis; Amphetamine/ Methamphetamine; Cocaine; Benzodiazepines; GHB; Hallucinogenics (e.g. LSD, mushrooms, mescaline); Anabolic steroids; Khat. 2. Frequency of use in the last 4 weeks: the response categories "used not more than 2-3 times per month" and " used 1-3 times a week" were collapsed into one category "used a few times", leaving three categories: "Not used", "used a few times" and "every day/nearly every day".
The Stressful Life-Events Screening Questionnaire (SLESQ)
时间窗: T1 (at enrollment in study)
The SLESQ assesses exposure to stressful life-events (yes/no) that could be potentially traumatizing. This version has been shortened and adapted in previous studies at the Norwegian Centre for Violence and Traumatic Stress Studies (NKVTS) for use in Norway and includes a list of 15 types of stressful events. This variable will be used to assess the prevalence of different types of stressful life-events. In addition the number of events can be summed to indicate the extent of exposure to stressful life-event, with a range from 0 events to 15. Modifications: 1. Two events have been added: Being directly involved in a natural disaster and having been repeatedly ridiculed, put down, ignored or told you were no good by someone outside the family. 2. When several of the 15 types of events have occured, the participants' age at the time of the event is only recorded for the first event and the event that gives the participant the most symptoms now.
The PTSD Checklist for DSM-5 - short version (PCL-5 short)
时间窗: T1 (at enrollment in study)
The short version of the PTSD Checklist for DSM-5 includes 4 items: 1 item for each symptom cluster for the diagnosis of PTSD according to the DSM-5. Participants indicate how much each symptom has bothered them in the last month on a scale from 0 to 4 ("Not at all" to "Very much"). The sum score ranges from 0 to 16. A score above the cut score of 10 indicates risk for PTSD, and has previously been validated as a diagnostic indicator.
次要结局
- Pain characteristics(T1 (at enrollment in study))
- Opioid maintenance treatment (OMT) history (selfmade)(T1 (at enrollment in study))
- Subjective quality of life (QOL-1)(T1 (at enrollment in study))
- The Brief Pain Inventory: Pain intensity(T1 (at enrollment in study))
- The Brief Pain Inventory: Pain interference(T1 (at enrollment in study))
- Nicotine use(T1 (at enrollment in study))
- Other pain related questions (selfmade)(T1 (at enrollment in study))
- Demographics(T1 (at enrollment in study))
- ICD-10/11 diagnostic codes(Retrospective (back to 2008) and prospective (5 year follow-up from completion of the questionnaire))
- Prescribed medications(Retrospective (back to 2004) and prospective (5 year follow-up from completion of the questionnaire))
- Treatments in the primary health services(Retrospective (back to 2016) and prospective (5 year follow-up from completion of the questionnaire))
- Pain treatment(Retrospective (back to 2013) and prospective (5 year follow-up from completion of the questionnaire))
- Treatments of patients with severe physical trauma(Retrospective (since establishment of database) and prospective (5 year follow-up from completion of the questionnaire))
- Cancer diagnosis and treatments(Retrospective (since establishment of database) and prospective (5 year follow-up from completion of the questionnaire))
- Time and cause of death(Prospective (5 year follow-up from completion of the questionnaire))
- Level of education(Retrospective (back to 1960s) and prospective (5 year follow-up from completion of the questionnaire))
- Birthcountry and immigration status(Retrospective (back to 1960s) and prospective (5 year follow-up from completion of the questionnaire))
- Income and employment status(Retrospective (back to 1960s) and prospective (5 year follow-up from completion of the questionnaire))
- Living conditions(Retrospective (back to 1960s) and prospective (5 year follow-up from completion of the questionnaire))
研究者
Ingeborg Skjarvo
Researcher
University Hospital, Akershus