The Norwegian Addiction, Pain and Trauma Study

NCT04908410 | Active Not Recruiting

• 1 other identifier: 2020/173249(REK)
• Study Type: observational
• Target: 1,650
• Locations: 1 country
• Sites: 4

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, 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.

Conditions

Chronic Pain; Post-traumatic Stress Disorder; Substance Use Disorders

Keywords

Opioid; Alcohol; Amphetamine; Cannabis; Marijuana; Methadone; Buprenorphine; Opioid maintenance treatment; Chronic pain; Post-traumatic stress

Outcome Measures

Primary Outcomes (4)

• Chronic pain (ICD-10)

  Defined as having experienced pain with a duration of at least 3 months.

  T1 (at enrollment in study)

• European-Addiction Severity Index (EuropASI), Section E

  * 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".

  T1 (at enrollment in study)

• The Stressful Life-Events Screening Questionnaire (SLESQ)

  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.

  T1 (at enrollment in study)

• The PTSD Checklist for DSM-5 - short version (PCL-5 short)

  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.

  T1 (at enrollment in study)

Secondary Outcomes (19)

• Pain characteristics

  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)

• Other pain related questions (selfmade)

  T1 (at enrollment in study)

• Opioid maintenance treatment (OMT) history (selfmade)

  T1 (at enrollment in study)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Akershus: lead
• Oslo University Hospital: collaborator
• Norwegian Center for Violence and Traumatic Stress Studies: collaborator
• The Hospital of Vestfold: collaborator
• Sykehuset Telemark: collaborator

Study Sites (4)

Akershus University Hospital

Lørenskog, 0192, Norway

Location

Oslo University Hospital

Oslo, Norway

Location

Telemark Hospital

Skien, Norway

Location

The Hospital in Vestfold

Tønsberg, Norway

Location

Related Publications (22)

• Latif ZH, Skjaervo I, Solli KK, Tanum L. Chronic Pain Among Patients With an Opioid Use Disorder. Am J Addict. 2021 Jul;30(4):366-375. doi: 10.1111/ajad.13153. Epub 2021 Mar 19.

  PMID: 33738870 BACKGROUND

• Rosenblum A, Joseph H, Fong C, Kipnis S, Cleland C, Portenoy RK. Prevalence and characteristics of chronic pain among chemically dependent patients in methadone maintenance and residential treatment facilities. JAMA. 2003 May 14;289(18):2370-8. doi: 10.1001/jama.289.18.2370.

  PMID: 12746360 BACKGROUND

• Boissoneault J, Lewis B, Nixon SJ. Characterizing chronic pain and alcohol use trajectory among treatment-seeking alcoholics. Alcohol. 2019 Mar;75:47-54. doi: 10.1016/j.alcohol.2018.05.009. Epub 2018 May 25.

  PMID: 30359794 BACKGROUND

• Witkiewitz K, Vowles KE. Alcohol and Opioid Use, Co-Use, and Chronic Pain in the Context of the Opioid Epidemic: A Critical Review. Alcohol Clin Exp Res. 2018 Mar;42(3):478-488. doi: 10.1111/acer.13594. Epub 2018 Feb 6.

  PMID: 29314075 BACKGROUND

• Larney S, Peacock A, Mathers BM, Hickman M, Degenhardt L. A systematic review of injecting-related injury and disease among people who inject drugs. Drug Alcohol Depend. 2017 Feb 1;171:39-49. doi: 10.1016/j.drugalcdep.2016.11.029. Epub 2016 Dec 8.

  PMID: 28013096 BACKGROUND

• Pud D, Cohen D, Lawental E, Eisenberg E. Opioids and abnormal pain perception: New evidence from a study of chronic opioid addicts and healthy subjects. Drug Alcohol Depend. 2006 May 20;82(3):218-23. doi: 10.1016/j.drugalcdep.2005.09.007. Epub 2005 Oct 17.

  PMID: 16229972 BACKGROUND

• Phillips K, Clauw DJ. Central pain mechanisms in chronic pain states--maybe it is all in their head. Best Pract Res Clin Rheumatol. 2011 Apr;25(2):141-54. doi: 10.1016/j.berh.2011.02.005.

  PMID: 22094191 BACKGROUND

• Egli M, Koob GF, Edwards S. Alcohol dependence as a chronic pain disorder. Neurosci Biobehav Rev. 2012 Nov;36(10):2179-92. doi: 10.1016/j.neubiorev.2012.07.010. Epub 2012 Sep 11.

  PMID: 22975446 BACKGROUND

• Apkarian AV, Neugebauer V, Koob G, Edwards S, Levine JD, Ferrari L, Egli M, Regunathan S. Neural mechanisms of pain and alcohol dependence. Pharmacol Biochem Behav. 2013 Nov;112:34-41. doi: 10.1016/j.pbb.2013.09.008. Epub 2013 Oct 2.

  PMID: 24095683 BACKGROUND

• Hill KP. Medical Marijuana for Treatment of Chronic Pain and Other Medical and Psychiatric Problems: A Clinical Review. JAMA. 2015 Jun 23-30;313(24):2474-83. doi: 10.1001/jama.2015.6199.

  PMID: 26103031 BACKGROUND

• Zvolensky MJ, Cougle JR, Bonn-Miller MO, Norberg MM, Johnson K, Kosiba J, Asmundson GJ. Chronic pain and marijuana use among a nationally representative sample of adults. Am J Addict. 2011 Nov-Dec;20(6):538-42. doi: 10.1111/j.1521-0391.2011.00176.x. Epub 2011 Oct 4.

  PMID: 21999500 BACKGROUND

• Alford DP, German JS, Samet JH, Cheng DM, Lloyd-Travaglini CA, Saitz R. Primary Care Patients with Drug Use Report Chronic Pain and Self-Medicate with Alcohol and Other Drugs. J Gen Intern Med. 2016 May;31(5):486-91. doi: 10.1007/s11606-016-3586-5. Epub 2016 Jan 25.

  PMID: 26809204 BACKGROUND

• Chen AL, Chen TJ, Waite RL, Reinking J, Tung HL, Rhoades P, Downs BW, Braverman E, Braverman D, Kerner M, Blum SH, DiNubile N, Smith D, Oscar-Berman M, Prihoda TJ, Floyd JB, O'Brien D, Liu HH, Blum K. Hypothesizing that brain reward circuitry genes are genetic antecedents of pain sensitivity and critical diagnostic and pharmacogenomic treatment targets for chronic pain conditions. Med Hypotheses. 2009 Jan;72(1):14-22. doi: 10.1016/j.mehy.2008.07.059. Epub 2008 Oct 31.

  PMID: 18951726 BACKGROUND

• Larson MJ, Paasche-Orlow M, Cheng DM, Lloyd-Travaglini C, Saitz R, Samet JH. Persistent pain is associated with substance use after detoxification: a prospective cohort analysis. Addiction. 2007 May;102(5):752-60. doi: 10.1111/j.1360-0443.2007.01759.x.

  PMID: 17506152 BACKGROUND

• Sharp TJ, Harvey AG. Chronic pain and posttraumatic stress disorder: mutual maintenance? Clin Psychol Rev. 2001 Aug;21(6):857-77. doi: 10.1016/s0272-7358(00)00071-4.

  PMID: 11497210 BACKGROUND

• Fishbain DA, Pulikal A, Lewis JE, Gao J. Chronic Pain Types Differ in Their Reported Prevalence of Post -Traumatic Stress Disorder (PTSD) and There Is Consistent Evidence That Chronic Pain Is Associated with PTSD: An Evidence-Based Structured Systematic Review. Pain Med. 2017 Apr 1;18(4):711-735. doi: 10.1093/pm/pnw065.

  PMID: 27188666 BACKGROUND

• Moeller-Bertram T, Keltner J, Strigo IA. Pain and post traumatic stress disorder - review of clinical and experimental evidence. Neuropharmacology. 2012 Feb;62(2):586-97. doi: 10.1016/j.neuropharm.2011.04.028. Epub 2011 May 10.

  PMID: 21586297 BACKGROUND

• Ouimette P, Goodwin E, Brown PJ. Health and well being of substance use disorder patients with and without posttraumatic stress disorder. Addict Behav. 2006 Aug;31(8):1415-23. doi: 10.1016/j.addbeh.2005.11.010. Epub 2005 Dec 27.

  PMID: 16380217 BACKGROUND

• Barry DT, Beitel M, Cutter CJ, Garnet B, Joshi D, Rosenblum A, Schottenfeld RS. Exploring relations among traumatic, posttraumatic, and physical pain experiences in methadone-maintained patients. J Pain. 2011 Jan;12(1):22-8. doi: 10.1016/j.jpain.2010.04.006. Epub 2010 Jun 20.

  PMID: 20646965 BACKGROUND

• Flanagan JC, Korte KJ, Killeen TK, Back SE. Concurrent Treatment of Substance Use and PTSD. Curr Psychiatry Rep. 2016 Aug;18(8):70. doi: 10.1007/s11920-016-0709-y.

  PMID: 27278509 BACKGROUND

• Pacella ML, Girard JM, Wright AGC, Suffoletto B, Callaway CW. The Association Between Daily Posttraumatic Stress Symptoms and Pain Over the First 14 Days After Injury: An Experience Sampling Study. Acad Emerg Med. 2018 Aug;25(8):844-855. doi: 10.1111/acem.13406.

  PMID: 29513381 BACKGROUND

• Skjaervo I, Marciuch A, Digranes LW, Folleras LM, Mordal J, Solli KK, Abel EKF, Amundsen K, Egeland K, Haugen BK, Holmoy B, Skoftedalen JG, Weimand BM, Tanum L. Chronic Pain and Posttraumatic Stress Among Patients in Substance Use Treatment: Protocol for NOR-APT, a Longitudinal Cohort Study. JMIR Res Protoc. 2025 Dec 24;14:e67663. doi: 10.2196/67663.

  PMID: 41442162 DERIVED

MeSH Terms

Conditions

Chronic Pain; Stress Disorders, Post-Traumatic; Substance-Related Disorders; Marijuana Abuse

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Chemically-Induced Disorders

Study Officials

• Ingeborg Skjærvø, PhD

  Ingeborg Skjærvø

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: June 1, 2021
• Study Start: March 23, 2021
• Primary Completion: June 2, 2024
• Study Completion (Estimated): December 31, 2030
• Last Updated: December 27, 2024

Record last verified: 2024-12

Locations

NO (4)