PTSDNCT04336605
Killing Pain - Use of Analgesic, Sedative and Anxiolytic Medication and the Development of Psychiatric Illness in Adolescents
An observational study of PTSD and Psychiatric Illness, run by Norwegian Center for Violence and Traumatic Stress Studies at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 32 yearsHealthy volunteers can take part
- Conditions the study is for
- PTSD, Psychiatric Illness, Prescription Drug Dependence
- What is being tested?
- Age & Development, Socioeconomy and Traumatic Events
- How many people
- 25,000 participants
- Where
- 1 siteNorway
- Study dates
- 1 Feb 2020to 31 Jan 2025
- How long will I take part?
- 25 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 32 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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).
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Norway1 site
Norwegian Centre for Violence and Traumatic Stress Studies
Oslo, 0409
About this study
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.
Read the detailed description
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:
- Prevalence and comorbidity of migraine, other headache, chronic widespread pain, fatigue, insomnia and posttraumatic stress reactions and related risk profiles among adolescents.
- How do discrepancies in risk \& comorbidity profiles differentially affect young peoples' risk of analgesic, sedative, and anxiolytic medication overuse over time?
- Do early somatic and psychological symptoms and self-medication in adolescence mediate risk of prescription drugs overuse in young people?
- The role of early symptomatology and prescription drug overuse as predictive factors for development of severe psychiatric illness by young adulthood (age 29).
- Conditions
- PTSD, Psychiatric Illness, Prescription Drug Dependence, Addiction
- Being tested
- Age & Development, Socioeconomy, Traumatic Events, Psychosocial conditions, Lifestyle
- Keywords
- PTSD, Psychiatric Illness, Prescription drugs, Addiction, Adolescents
- Medical subject headings
- Stress Disorders, Post-Traumatic, Mental Disorders, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Age & DevelopmentOther
Age, sex, pubertal onset and development
SocioeconomyOther
Family structure and economy
Traumatic EventsOther
Violence and other traumatic events
Psychosocial conditionsOther
Family/social support
LifestyleOther
Physical activity, BMI, nutrition, smoking …
Chronic conditionsOther
I.e. Epilepsy or juvenile rheumatoid arthritis ...
Somatic symptomsOther
Headache, pain, sleep disturbances ...
Psychological symptomsOther
PTSS, anxiety, depressive symptoms \& loneliness ...
Non-prescription analgesicsOther
Non-prescription analgesics
Prescription drugsOther
Analgetic, sedative \& anxiolytic medication
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prescription drugs
Analgetic, sedative \& anxiolytic medication
Measured: 2006-2020
Psychiatric Illness
Medically treated severe mental illness, i.e. depression, psychosis, dependency or addiction disorders
Measured: 2006-2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2020
- Study start1 Feb 2020
- Primary completion31 Jan 2023 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PTSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25,000 participants (actual)
- Target duration
- 25 Years
Sponsor and investigators
- Lead sponsor
- Norwegian Center for Violence and Traumatic Stress Studies
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital, The Change Factory, Norwegian Council for Mental Health, The Dam Foundation, Norwegian Institute of Public Health
- Responsible party
- Principal investigator, Synne O. B. Stensland, Norwegian Center for Violence and Traumatic Stress Studies
- Investigators
- Synne O Stensland, MD PhD, Principal investigator, Norwegian Centre for Violence and Traumatic Stress Studies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04336605
- Sponsor's protocol ID
- Killing Pain
- Other IDs
- A pill for the pain
- Status last verified
- Apr 2020
- First submitted
- 3 Apr 2020
- Last updated
- 9 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37574601Stangeland 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.
PubMed 36030342
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Killing Pain - Use of Analgesic, Sedative and Anxiolytic Medication and the Development of Psychiatric Illness in Adolescents
- ClinicalTrials.gov ID
- NCT04336605
- Acronym / sponsor ID
- Killing Pain
- Conditions
- PTSD, Psychiatric Illness, Prescription Drug Dependence, Addiction
- Keywords
- PTSD, Psychiatric Illness, Prescription drugs, Addiction, Adolescents
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25,000 participants (actual)
- Lead sponsor
- Norwegian Center for Violence and Traumatic Stress StudiesUniversity, hospital or other
- Collaborators
- Oslo University Hospital, The Change Factory, Norwegian Council for Mental Health, The Dam Foundation, Norwegian Institute of Public Health
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 31 Jan 2023 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 7 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Prevalence and comorbidity of migraine, other headache, chronic widespread pain, fatigue, insomnia and posttraumatic stress reactions and related risk profiles among adolescents.
- How do discrepancies in risk \& comorbidity profiles differentially affect young peoples' risk of analgesic, sedative, and anxiolytic medication overuse over time?
- Do early somatic and psychological symptoms and self-medication in adolescence mediate risk of prescription drugs overuse in young people?
- The role of early symptomatology and prescription drug overuse as predictive factors for development of severe psychiatric illness by young adulthood (age 29).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 25 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Young-HUNT | – | 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 drugsThe 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. |
Who may qualify
- Ages
- 13 to 32 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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).
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Age & DevelopmentAge, sex, pubertal onset and development | Other | Young-HUNT |
| SocioeconomyFamily structure and economy | Other | Young-HUNT |
| Traumatic EventsViolence and other traumatic events | Other | Young-HUNT |
| Psychosocial conditionsFamily/social support | Other | Young-HUNT |
| LifestylePhysical activity, BMI, nutrition, smoking … | Other | Young-HUNT |
| Chronic conditionsI.e. Epilepsy or juvenile rheumatoid arthritis ... | Other | Young-HUNT |
| Somatic symptomsHeadache, pain, sleep disturbances ... | Other | Young-HUNT |
| Psychological symptomsPTSS, anxiety, depressive symptoms \& loneliness ... | Other | Young-HUNT |
| Non-prescription analgesicsNon-prescription analgesics | Other | Young-HUNT |
| Prescription drugsAnalgetic, sedative \& anxiolytic medication | Other | Young-HUNT |
Primary outcome
Prescription drugs
Time frame: 2006-2020
Analgetic, sedative \& anxiolytic medication
Psychiatric Illness
Time frame: 2006-2020
Medically treated severe mental illness, i.e. depression, psychosis, dependency or addiction disorders
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2020.
- Derived from this study: PubMed 37574601Baumann-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.
- Derived from this study: PubMed 36030342Stangeland 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Synne O Stensland, MD PhD principal investigator
Norwegian Centre for Violence and Traumatic Stress Studies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PTSD and Psychiatric Illness, run by Norwegian Center for Violence and Traumatic Stress Studies at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prescription drugs (time frame: 2006-2020). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04336605, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2020.