The Norwegian Addiction, Pain and Trauma Study (NOR-APT)
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|ClinicalTrials.gov Identifier: NCT04908410|
Recruitment Status : Recruiting
First Posted : June 1, 2021
Last Update Posted : March 30, 2023
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THIS STUDY DOES NOT OFFER ANY FORM OF TREATMENT FOR PTSD, PAIN OR SUBSTANCE DEPENDENCE.
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, where the goal is to recruit 1 500 patients from outpatient and inpatient substance use treatment centres connected to Akershus University Hospital and Oslo University Hospital in Norway. Participants are invited to complete a questionnaire about substance/medication use, pain and how pain affect function, stressful life events and post-traumatic stress symptoms. The questionnaire has been developed in collaboration with clinicians at the various substance dependence treatment units and the Norwegian Centre for Violence and Traumatic Stress Studies (NKVTS).
The purpose of the Nor-APT 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 four 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.
In addition, the investigators 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.
|Condition or disease|
|Chronic Pain Post-traumatic Stress Disorder Substance Use Disorders|
|Study Type :||Observational|
|Estimated Enrollment :||1500 participants|
|Official Title:||The Norwegian Addiction, Pain and Trauma Study|
|Actual Study Start Date :||March 23, 2021|
|Estimated Primary Completion Date :||December 30, 2023|
|Estimated Study Completion Date :||February 1, 2024|
- Chronic pain (ICD-10) [ Time Frame: 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 [ Time Frame: 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)
- 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.
- 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) [ Time Frame: 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.
- 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.
- 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) [ Time Frame: 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.
- Pain characteristics [ Time Frame: T1 (at enrollment in study) ]
Patients that report any pain in the last 4 weeks are asked:
- to indicate the location/s of the pain on a body map with 25 different pain locations (from the Norwegian Pain Association)
- to indicate any generalized pain in the skin, muscles, joints or skeleton/bones (selfmade checklist).
- the duration of their pain (less than 3 months; 3-12 months; 1-3 years; 4-6 years; 7-10 years; more than 10 years)
- the cause of their pain (illness; accident/injury; violence; surgery; other; unknown), their age at that time and whether they believe the cause was related to their substance use (selfmade questions, the list of causes collected from previous studies).
- The Brief Pain Inventory: Pain intensity [ Time Frame: T1 (at enrollment in study) ]Pain intensity will be assess with 4 items addressing pain intensity right now; on average; the strongest in the last week; the weakest in the last week. Responses are given on an 11 point numeric rating scale from 0 "No pain" to 10 "The worst pain imaginable". These 4 items can be used independently or averaged.
- The Brief Pain Inventory: Pain interference [ Time Frame: T1 (at enrollment in study) ]
Pain interference on different life domains in the last week will be assessed with 7 items from the BPI: general activity, ability to walk, normal work/housework, mood, sleep, relationships to others, enjoyment of life
Responses are given on an 11 point numeric rating scale from 0 "Not influenced at all" to 10 "Completely influenced".
The 7 items can be averaged to give an overall interference score from 0 (low) to 10 (high), or they can be divided into affective interference (mood, sleep, relationships, enjoyment of life) and activity interference (walking, activity, work).
In addition, we include1 selfmade item in the same format, about interference on subjective quality of life: satisfaction with life.
- Other pain related questions (selfmade) [ Time Frame: T1 (at enrollment in study) ]
- Have you contacted a medical doctor for help with your pain? (Yes/no). If yes, age at the time (open ended question)
- Did you receive treatment for your pain? (yes/no) If yes, what type of treatment (open ended question).
- Is it difficult for you now to stop using substances/medications because of
- pain? (No/ A little/ Very)
- worrying about pain? (No/ A little/ Very)
- Are there substance/medications (including over the counter pain medications) that...
- ...help with your pain? (open ended question)
- ... make your pain worse? (open ended question)
- The first time you used opioids, was it to relieve pain? (Never used opioids/No/Yes/Don't know)
- Has pain ever influenced the type of medication received in OMT? (No/Yes/Don't know) If yes, which medication? (open ended), what was your age at the time? (open ended), Any comments? (open ended).
- Opioid maintenance treatment (OMT) history (selfmade) [ Time Frame: T1 (at enrollment in study) ]
- Have you ever been in OMT? (No/Methadone/Subutex/Buvidal/Suboxone/Other (specify)) Age at the time of the first prescription.
- Are you in OMT now? (No/Methadone/Subutex/Buvidal/Suboxone/Other (specify)) Age at the start of this prescription.
- Subjective quality of life (QOL-1) [ Time Frame: T1 (at enrollment in study) ]- How satisfied are you with your life? The response is given on an 11-point numeric rating scale, from 0 "Not satisfied at all" to 10 "Very satisfied".
- Demographics [ Time Frame: T1 (at enrollment in study) ]
- Gender (Woman/man)
- Are you currently working/studying? (No/Yes (full or parttime) OR On sickleave/Retired/Disabled)
- Nicotine use [ Time Frame: T1 (at enrollment in study) ]
- Do you smoke cigarettes or a pipe? (Yes/No)
- Do you use snuff? (Yes/No)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- Patient in substance use treatment at a treatment centre under Akershus University Hospital or Oslo University Hospital.
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04908410
|Contact: Ingeborg Skjærvø, PhDemail@example.com|
|Contact: Lars Tanum, MD, DMScifirstname.lastname@example.org|
|Akershus University Hospital||Recruiting|
|Lørenskog, Norway, 0192|
|Contact: Ingeborg Skjærvø, PhD 41453842 email@example.com|
|Contact: Lars Tanum, PhD 004793202038 firstname.lastname@example.org|
|Oslo University Hospital||Recruiting|
|Contact: Kim Amundsen email@example.com|
|Telemark Hospital||Not yet recruiting|
|Contact: Britt K Haugen firstname.lastname@example.org|
|The Hospital in Vestfold||Recruiting|
|Contact: Kristin K Solli, PhD email@example.com|
|Principal Investigator: Kristin K Solli, PhD|
|Principal Investigator:||Ingeborg Skjærvø, PhD||Ingeborg Skjærvø|
Documents provided by Ingeborg Skjarvo, University Hospital, Akershus:
|Responsible Party:||Ingeborg Skjarvo, Researcher, University Hospital, Akershus|
|Other Study ID Numbers:||
|First Posted:||June 1, 2021 Key Record Dates|
|Last Update Posted:||March 30, 2023|
|Last Verified:||March 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Opioid maintenance treatment
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders