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The Norwegian Addiction, Pain and Trauma Study (NOR-APT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04908410
Recruitment Status : Recruiting
First Posted : June 1, 2021
Last Update Posted : June 1, 2021
Sponsor:
Collaborators:
Oslo University Hospital
Norwegian Center for Violence and Traumatic Stress Studies
Information provided by (Responsible Party):
Ingeborg Skjarvo, University Hospital, Akershus

Tracking Information
First Submitted Date May 18, 2021
First Posted Date June 1, 2021
Last Update Posted Date June 1, 2021
Actual Study Start Date March 23, 2021
Estimated Primary Completion Date December 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 27, 2021)
  • 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)
    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, MDMA); 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) [ 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. 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) [ 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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: May 27, 2021)
  • 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) ]
    • Age
    • 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)
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Norwegian Addiction, Pain and Trauma Study
Official Title The Norwegian Addiction, Pain and Trauma Study
Brief Summary

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.

Detailed Description

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.

A study of the general population in the United States found a link between chronic pain and marijuana use, but could not discern whether the pain or marijuana use came first. In a small study, two out of five people using marijuana or cocaine reported using the substances as pain relief. Amphetamine is also a highly relevant substance when it comes to pain, as amphetamines can be analgesic, and can enhance the analgesic effect of opioids.

Chronic pain is associated with poorer treatment outcomes, however there is little knowledge about how co-occurring chronic pain and substance dependence develops over time. More knowledge about the mechanisms behind co-occurring chronic pain and dependence can contribute to better treatment options for patients, both when it comes to the treatment of pain and dependence.

Chronic pain and PTSD

Chronic pain and pain intensity have a documented association with post-traumatic stress disorder (PTSD) in the general population, but have not been much explored among people with dependence. A small study has found a higher prevalence of chronic pain among people with co-occurring substance dependence and PTSD, but the study was not large enough (n = 133) to distinguish between dependence on different types of substances. One study (n = 150) found a higher prevalence of PTSD among methadone patients with chronic pain.

Unfortunately, PTSD is a diagnosis that has historically been considered difficult to treat among people with substance use disorder. Therefore PTSD is undertreated for these patients.

The link between chronic pain and PTSD is not fully understood. In some cases, the pain may be caused by a physical injury in connection with the event that caused the PTSD. Beyond these cases, some theories focus on shared vulnerability, or that chronic pain and PTSD reinforce each other through excessive reactions to or misinterpretation of stress or pain stimuli. Other theories focus on the biological aspects, such as dysregulation of the nervous system or dysregulation of opioid receptors.

It is also possible that the PTSD symptoms associated with overactivation may drive the association between PTSD and pain. This makes it relevant to explore any potential interaction effects of PTSD symptoms and the use of sedative and stimulating substances/medications on the experience of pain.

A better understanding of the links between chronic pain, PTSD and dependence can mean a lot for better treatment of patients with comorbid substance dependence, PTSD and pain disorders.

METHODS

Design. Cross-sectional survey study. Multicentre, with data collected from 15 substance use treatment centres in the catchment areas for Akershus University Hospital and Oslo University Hospital in Norway.

Participants. The goal is to recruit 1 500 patients entering any form of substance use treatment at the 15 collaborating inpatient and outpatient clinics.

Staff at the treatment centres are instructed to ask all patients. At the time-points where 500 and 1 000 questionnaires have been completed, the investigators will assess the distribution of participants according to their primary substance use problem/the substance they are in treatment for. If the distribution is skewed in a manner that may not give enough data about some sub-groups of substance users, the investigators may encourage staff at the treatment centres to continue with more selective recruitment of the patient groups that are underrepresented. For instance, many patients are treated for opioid or alcohol dependence, so this group may be recruited faster and more easily, while patients with a primary dependence to cannabis or amphetamines may be fewer and could require more time and effort to reach a sufficiently large sample size.

Materials. The questionnaire was developed based on the research questions, previous literature, and in collaboration with the clinicians that see the patient groups in their day to day practice at Akershus University Hospital and Oslo University Hospital. The questionnaire was piloted on 10 patients with different substance use patterns, where patients were asked to comment on the experience of filling in the questionnaire, the length and clarity of the questions, and give any other comments or suggestions. Further adjustments to the layout and wording of certain questions were made based on the results of the piloting.

To make the data-collection process as uniform as possible, a questionnaire guide for staff was made, with a standard text for introducing and explaining the questionnaire to patients, and with a walk-through of the questions with additional explanations, definitions and problem-solving for common issues when filling out the different type of questions. In the guide, other topics related to collecting survey-data were also addressed, such as concerns related to missing responses for data validity and how to balance the preference for complete answers with ensuring that all questions were answered on a completely voluntary basis.

An instructional 15 minute video for staff was made, with an explanation of the background and purpose of the study, as a measure to increase understanding and motivation for recruiting patients to the study.

Procedure. Each treatment centre has a study coordinator responsible for ensuring all staff has access to questionnaires, guides and the instructional video. The coordinators task is to inform staff and distributed the study material. The coordinator will also report on progress, issues and concerns to the central study coordinators throughout the data collection period.

Staff at the treatment centres are instructed to invite all patients (except those affected by the exclusion criteria) to participate. Patients will be informed that participation is voluntary and that declining to participate will not affect the treatment they receive, about the purpose of the study and how the information they give will be handled. The number of patients that decline participation will be logged, and if the patients consent to disclosing the information, the gender, age and which substance they are in treatment for/their primary substance problem, will also be logged for patients that decline participation.

Patients that agree to participate will complete the consent form and the questionnaire. If they wish to withdraw from the study at a later time, they can contact the treatment centre or the research group.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients (ages 18 years - unlimited) in treatment for substance use disorders at outpatient and inpatient treatment centers connected to Akerhus University Hospital or Oslo University Hospital, Norway.
Condition
  • Chronic Pain
  • Post-traumatic Stress Disorder
  • Substance Use Disorders
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 27, 2021)
1500
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 1, 2024
Estimated Primary Completion Date December 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patient in substance use treatment at a treatment centre under Akershus University Hospital or Oslo University Hospital.

Exclusion Criteria:

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Ingeborg Skjærvø, PhD 004741453842 ingeborg.skjarvo@nkvts.no
Contact: Lars Tanum, MD, DMSci 004793202038 lars.tanum@ahus.no
Listed Location Countries Norway
Removed Location Countries  
 
Administrative Information
NCT Number NCT04908410
Other Study ID Numbers 2020/173249(REK)
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Current Responsible Party Ingeborg Skjarvo, University Hospital, Akershus
Original Responsible Party Same as current
Current Study Sponsor University Hospital, Akershus
Original Study Sponsor Same as current
Collaborators
  • Oslo University Hospital
  • Norwegian Center for Violence and Traumatic Stress Studies
Investigators
Principal Investigator: Ingeborg Skjærvø, PhD Ingeborg Skjærvø
PRS Account University Hospital, Akershus
Verification Date May 2021