Killing Pain - Use of Analgesic, Sedative and Anxiolytic Medication and the Development of Psychiatric Illness in Adolescents

NCT04336605 | Unknown

• 2 other identifiers: Killing PainA pill for the pain
• Study Type: observational
• Target: 25,000
• Locations: 1 country
• Sites: 1

Brief Summary

Prescription of analgesic, sedative, and anxiolytic medication for children and adolescents is increasing in Western countries. In recent decades, rates have also increased in Norway, despite a relatively restrictive prescription practice. Analgesics, sedatives, and anxiolytics are among the medications most commonly prescribed to young people by general practitioners and others. Overuse of such medication adversely impacts individual and societal health, social and economic measures. For example, the risk of chronification of pain, development of addiction, and dropout from school and the workforce is high. Epidemiological research has largely failed to integrate vulnerable, young service users' perspectives in planning, interpretation and dissemination of results. This has resulted in limited identification of potential causes for the increasing exposure to prescription and overuse of analgesics and other addictive drugs among of children and adolescents, and the long-term consequences this may have for morbidity and addiction in early adulthood. Knowledge of early risk factors and plausible causal mechanisms is crucial for the development of timely and effective interventions to prevent inappropriate prescriptions in clinical practice. This prospective, longitudinal cohort study examines the use of analgesic, sedative, and anxiolytic medication among about 25,000 children throughout adolescence and young adulthood (1995 to 2020), specifically addressing changes in prescription over time, and early risk factors for the prescription of addictive drugs in adolescence and young adulthood and the subsequent development of mental health disorders.

Conditions

PTSD; Prescription Drug Dependence; Addiction; Psychiatric Illness

Keywords

PTSD; Psychiatric Illness; Prescription drugs; Addiction; Adolescents

Outcome Measures

Primary Outcomes (2)

• Prescription drugs

  Analgetic, sedative \& anxiolytic medication

  2006-2020

• Psychiatric Illness

  Medically treated severe mental illness, i.e. depression, psychosis, dependency or addiction disorders

  2006-2020

Study Arms (1)

Young-HUNT

The young-HUNT study is a renowned, representative, population-based study where all adolescents living in the Nord-Trøndelag county have been invited to participate in four subsequent waves, from 1995 to 2019. Information about the study can be found here: https://www.ntnu.edu/hunt/young-hunt. In this study data from the Young-HUNT1-4 studies (1995-2019) will be linked to longitudinal, individual data from the Norwegian prescription Database (NorPD) (2004-2020), providing a unique, longitudinal dataset in which research questions will be explored. To obtain good, reliable follow-up data and outcome measures for the young-HUNT3 participants (2006-2008) the investigators will additionally include longitudinal data from the HUNT4 study of young adults (2017-2019); applicable for those participating in both the YoungHUNT3 and the YoungHUNT4.

Other: Age & Development; Other: Socioeconomy; Other: Traumatic Events; Other: Psychosocial conditions; Other: Lifestyle; Other: Chronic conditions; Other: Somatic symptoms; Other: Psychological symptoms; Other: Non-prescription analgesics; Other: Prescription drugs

Interventions

Age & Development OTHER

Age, sex, pubertal onset and development

Young-HUNT

Socioeconomy OTHER

Family structure and economy

Young-HUNT

Traumatic Events OTHER

Violence and other traumatic events

Young-HUNT

Psychosocial conditions OTHER

Family/social support

Young-HUNT

Lifestyle OTHER

Physical activity, BMI, nutrition, smoking …

Young-HUNT

Chronic conditions OTHER

I.e. Epilepsy or juvenile rheumatoid arthritis ...

Young-HUNT

Somatic symptoms OTHER

Headache, pain, sleep disturbances ...

Young-HUNT

Psychological symptoms OTHER

PTSS, anxiety, depressive symptoms \& loneliness ...

Young-HUNT

Non-prescription analgesics OTHER

Non-prescription analgesics

Young-HUNT

Prescription drugs OTHER

Analgetic, sedative \& anxiolytic medication

Young-HUNT

Eligibility Criteria

• Age: 13 Years - 32 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

All youth in Nord-Trøndelag county in Norway between 13-19 years were invited to participate in the four Young-HUNT study waves (1995-2019), and followed up after approximately 10 years between 2017-2020. In this study data from the Young-HUNT1-4 studies (1995-2019) will be linked to longitudinal, individual data from the Norwegian prescription Database (NorPD) (2004-2020), providing a unique, longitudinal dataset. To obtain good, reliable followup data for the young-HUNT3 participants (2006-2008) the investigators will additionally include longitudinal data of for those participating in both the YoungHUNT3 and the YoungHUNT4 (2017-2019).

You may qualify if:

• All youth in Nord-Trøndelag county were invited to participate in four subsequent Young-HUNT study waves (1995-2019), https://www.ntnu.edu/hunt/young-hunt

You may not qualify if:

• None

Sponsors & Collaborators

• Norwegian Center for Violence and Traumatic Stress Studies: lead
• Oslo University Hospital: collaborator
• The Change Factory: collaborator
• Norwegian Council for Mental Health: collaborator
• The Dam Foundation: collaborator
• Norwegian Institute of Public Health: collaborator

Study Sites (1)

Norwegian Centre for Violence and Traumatic Stress Studies

Oslo, 0409, Norway

Location

Related Publications (2)

• Baumann-Larsen M, Zwart JA, Dyb G, Wentzel-Larsen T, Stangeland H, Storheim K, Stensland SO. Killing pain? A prospective population-based study on trauma exposure in childhood as predictor for frequent use of over-the-counter analgesics in young adulthood. The HUNT study. Psychiatry Res. 2023 Sep;327:115400. doi: 10.1016/j.psychres.2023.115400. Epub 2023 Aug 1.

  PMID: 37574601 DERIVED

• Stangeland H, Handal M, Skurtveit SO, Aakvaag HF, Dyb G, Wentzel-Larsen T, Baumann-Larsen M, Zwart JA, Storheim K, Stensland SO. Killing pain?: a population-based registry study of the use of prescription analgesics, anxiolytics, and hypnotics among all children, adolescents and young adults in Norway from 2004 to 2019. Eur Child Adolesc Psychiatry. 2023 Nov;32(11):2259-2270. doi: 10.1007/s00787-022-02066-8. Epub 2022 Aug 27.

  PMID: 36030342 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Mental Disorders; Behavior, Addictive

Interventions

Aging; Growth and Development; Prescription Drugs

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Intervention Hierarchy (Ancestors)

Physiological Phenomena; Pharmaceutical Preparations

Study Officials

• Synne O Stensland, MD PhD

  Norwegian Centre for Violence and Traumatic Stress Studies

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 25 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator (MD, PhD)

Study Record Dates

• First Submitted: April 3, 2020
• First Posted: April 7, 2020
• Study Start: February 1, 2020
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2025
• Last Updated: April 9, 2020

Record last verified: 2020-04

Locations

NO (1)