PTSD Clinical Trial
Official title:
Killing Pain - Use of Analgesic, Sedative and Anxiolytic Medication and the Development of Psychiatric Illness in Adolescents
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.
Linking data from the renowned, representative, population-based Nord-Trøndelag Health
studies of adolescents (Young-HUNT, 1995-2019) to longitudinal, individual data from the
Norwegian prescription Database (NorPD) (2004-2020) provides a unique, longitudinal dataset
which will be examined in this study. Thus, the study design allows for examination of early
predictors, risk factors, and potential causal mechanisms of prescription drug (analgesic,
sedative, and anxiolytic medication) overuse, and development of severe mental illness in
young people.
The Young-HUNT3 (2006-2008) study is among the world's first representative health surveys of
youth encompassing questions about violence and other traumatic events, self-reported somatic
and psychological health measures, a clinical examination, and consent to linkage to
longitudinal health registries. The Young-HUNT4 (2017-2019) additionally includes validated
actigraphy measures of activity and sleep. The full cohort of adolescents living in
Nord-Trøndelag county were invited to participate in each of the study waves (HUNT1-4).
Participation rates have been exceptionally high ranging from 78-90%. During school hours,
the youth answered a number of health-related questions, including items on: physical
violence, sexual abuse, bullying, and a range of other traumatic events (in the youngHUNT3
and 4); diagnosed chronic disease such as epilepsy, migraine, or juvenile rheumatoid
arthritis; somatic and psychological symptoms, including recurrent headaches, abdominal pain,
other musculoskeletal pain, autonomic somatic symptoms, sleep difficulties, post-traumatic
stress reactions, psychological distress (anxiety/depression), and loneliness; use of
non-prescription analgesics; pubertal onset and developmental stage; lifestyle, such as
physical activity and nutrition; socio-economic and psychosocial factors. The study
additionally comprised a validated headache interview, and clinical anthropometric measures.
The HUNT4 included a week's measure of activity and sleep by the use of actigraphs.
Information on age and gender was obtained from the Norwegian National Population Registry.
Each Young-HUNT participant's 11-digit social security number will be linked to individual
data in the NorPD at the Norwegian Institute of Public Health. The NorPD registers all
prescription drugs dispensed from pharmacies in Norway, and the database therefore contains a
complete overview of all prescription drugs dispensed to individual patients outside
hospitals, since 2004. Non-prescription drugs and medicines purchased abroad are not
registered. Registered drugs are classified according to the International Anatomical
Therapeutic Chemical Classification System (ATC). In this study, the investigators include
information on the number of dispensed prescriptions of drugs classified within the following
ATC codes: M01 (anti-inflammatory and anti-rheumatic agents), N01A (anesthetics, general),
N02 (analgesics; opioids, other analgesics, and antipyretics and migraine agents), N05
(psycholeptics; antipsychotics, anxiolytics, hypnotics and anxiolytics), N06
(psychoanaleptics; antidepressants, ADHD and nootropics, and psycholeptics in combinations)
and N07B (drugs for addiction disorders) from 2004 up to time of linkage (2019/2020).
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.
The data material provides a unique opportunity to study the following research questions:
1. Prevalence and comorbidity of migraine, other headache, chronic widespread pain,
fatigue, insomnia and posttraumatic stress reactions and related risk profiles among
adolescents.
2. How do discrepancies in risk & comorbidity profiles differentially affect young peoples'
risk of analgesic, sedative, and anxiolytic medication overuse over time?
3. Do early somatic and psychological symptoms and self-medication in adolescence mediate
risk of prescription drugs overuse in young people?
4. The role of early symptomatology and prescription drug overuse as predictive factors for
development of severe psychiatric illness by young adulthood (age 29).
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