Mild Cognitive ImpairmentNCT03162081
Medication Misuse and Dependence Among Elderly
An observational study of Mild Cognitive Impairment and Elderly, run by University Hospital, Akershus at 1 site in Norway.
Trial summary
The project focuses on investigating problematic medication use, especially overuse of potentially addictive drugs among the elderly. The investigators aim firstly to develop and validate instruments for detecting and describing behavioral aspects and consequences of dependence on, and misuse of, prescription… Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Mild Cognitive Impairment, Elderly, Substance-Related Disorders
- What is being tested?
- Substance misuse screening, EQ-5D and Impulsivity screening
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 500 participants
- Where
- 1 siteNorway
- Study dates
- 3 May 2017to 31 Dec 2024
- How long will I take part?
- 2 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 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Study population: All admitted elderly 65-90 years of age are screened, for case-control age and gender-matched pairs of Users and non-users will in addition be examined in depth with neuropsychological tests
Who may be able to join
- Admitted to geriatric or Neurology dept of hospital during inclusion time
Who cannot join
- MMSE < 21,
- diagnosis of pre-existing severe depression or psychotic disease,
- pre-existing dementia diagnosis,
- new pain requiring start-up of central pain killers not previously used,
- Palliative treatment.
- Insufficient Norwegian language
- Serious visual disturbance and hearing impairment
- Strongly reduced general health precluding partcipation in interview and questionnaires
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Medication Misuse and Dependence in Elderly Patients
The project focuses on investigating problematic medication use, especially overuse of potentially addictive drugs among the elderly.
The investigators aim firstly to develop and validate instruments for detecting and describing behavioral aspects and consequences of dependence on, and misuse of, prescription medication among elderly.
In addition to evaluating diagnostic utility of screening instruments, the investigators aim to identify and report characteristics, risk factors and consequences of medication misuse and dependence among the elderly.
Read the detailed description
Elderly represent a particularly vulnerable group with many contributing factors including age-related multifactorial morbidity, cognitive function, polypharmacy, dependence and multiple prescribers with suboptimal communication. Centrally active pain killers and sedative/hypnotic medications give increased risk of addiction, adverse drug events, reduced physical and/or cognitive function.
The project comprises diagnostic accuracy, descriptive screening, cross-sectional and case-control studies, with aims to: i) assess diagnostic utility of instruments for elderly patients; ii) describe risk factors for medication misuse and dependence; iii) describe consequences of the use of centrally active medications among elderly compared to a control population.
Moreover, the investigators aim to examine the association between medication misuse and changes in cognitive function, focusing on deficits in specific domains of cognition. An additional aim is to explore the possibility of dissociating such cognitive changes from other causes of mild cognitive impairment (MCI) associated with development of dementia.
- Being tested
- Substance misuse screening, EQ-5D, Impulsivity screening, Cognitive screening, Functional tests
- Keywords
- addiction, cognition, impulsivity, neuropsychology, prescription drug misuse, dependence
- Medical subject headings
- Cognitive Dysfunction, Substance-Related Disorders, Behavior, Addictive, Impulsive Behavior, Prescription Drug Misuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Substance misuse screeningDiagnostic test
Diagnostic and Statistical manual of mental disorders, version 4 (DSM-IV)/MINI-international Neuropsychiatric interview (MINI interview) for Diagnostics of dependence, additional questions for DSM-V classification, severity of dependence scale (SDS)
EQ-5DDiagnostic test
Health related Quality of life
Impulsivity screeningDiagnostic test
Barratts impulsivity test v. 11, Behavioural inhibition/behavioural activation test
Cognitive screeningDiagnostic test
Minimental state examination (MMSE), Hospital anxiety and depression scale (HADS), Trail-making test, clock drawing test
Functional testsDiagnostic test
Timed up and go (TUG), Single leg balancing test (SLB)
CognistatDiagnostic test
Assessment of cognitive domains
Neuropsychological profilingDiagnostic test
Controlled Oral Word Association Test, Categorical fluency tests, Wechsler Adult Intelligence Scale, Color-Word Interference Test (CWIT) from the Delis-Kaplan Executive Function test
Clinical interviewOther
Interview for sociodemographics, utilisation of health care, economic varables, The De Jong Gierveld Loneliness Scale
Medication useOther
Detailed screen of used medications, interactions, side effects in electronic patient registry
ComorbidityOther
Charlson comorbidity index and Cumulated illness rating scale (CIRS) based on electronic patient registry
| Study group | Role | What they receive |
|---|---|---|
| Users | Elderly patients who use prescription benzodiazepines/Z-hypnotics or opiates
Clinical interview, Substance misuse screening, EuroQol five dimensional health-related quality of life questionnaires (EQ-5D), Impulsivity screening, Cognitive screening, Functional tests, Cognistat Neurobehavioural cognitive status examination (Cognistat), Neuropsychological profiling, Medication use, Comorbidity Receives: Diagnostic Test: Substance misuse screening; Diagnostic Test: EQ-5D; Diagnostic Test: Impulsivity screening; Diagnostic Test: Cognitive screening; Diagnostic Test: Functional tests; Diagnostic Test: Cognistat; Diagnostic Test: Neuropsychological profiling; Other: Clinical interview; Other: Medication use; Other: Comorbidity | |
| Non-users | Age and gender matched controls not using the above
Clinical interview, Substance misuse screening, EuroQol five dimensional health-related quality of life questionnaires (EQ-5D), Impulsivity screening, Cognitive screening, Functional tests, Cognistat Neurobehavioural cognitive status examination (Cognistat), Neuropsychological profiling, Medication use, Comorbidity Receives: Diagnostic Test: Substance misuse screening; Diagnostic Test: EQ-5D; Diagnostic Test: Impulsivity screening; Diagnostic Test: Cognitive screening; Diagnostic Test: Functional tests; Diagnostic Test: Cognistat; Diagnostic Test: Neuropsychological profiling; Other: Clinical interview; Other: Medication use; Other: Comorbidity | |
| Screening group | Patients over 65 admitted to hospital as in-patients
Clinical interview, Substance misuse screening, EuroQol five dimensional health-related quality of life questionnaires (EQ-5D), Impulsivity screening, Cognitive screening, Functional tests, Medication use, Comorbidity Receives: Diagnostic Test: Substance misuse screening; Diagnostic Test: EQ-5D; Diagnostic Test: Impulsivity screening; Diagnostic Test: Cognitive screening; Diagnostic Test: Functional tests; Other: Clinical interview; Other: Medication use; Other: Comorbidity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dependence y/n
DSM-IV defined substance dependence assessed by MINI interview
Measured: Within 2 weeks of admission
Medication misuse y/n
Use of any of: opiates/benzodiazepine/Z-hypnotics >5 days per week for >3 months
Measured: Past year prior to in-hospital stay (data collected within 2 weeks of admission)
Secondary outcomes (20)
MCI - Mild cognitive impairment
Defined by MMSE < 26
Measured: Within 2 weeks of admission
MMSE
Numerical score of cognitive function
Measured: Within 2 weeks of admission
COGNISTAT
Cognitive profile
Measured: Within 2 weeks of admission
EQ-5D
Quality of life
Measured: Within 2 weeks of admission
BIS-11
Impulsivity score
Measured: Within 2 weeks of admission
BIS/BAS score
Behavioura inhibition/activation score
Measured: Within 2 weeks of admission
TUG
Functional test score (time in secs)
Measured: Within 2 weeks of admission
SLB
Functional test score (time in secs)
Measured: Within 2 weeks of admission
Neuropsychological profiles
Tests as listed
Measured: Within 2 weeks of admission
Use of addictive medication y/n
Prescription use of any of the following: opiates, benzodiazepines, Z-hypnotics
Measured: Within 2 weeks of admission
No of days of use of defined addictive medications/month
No. days of use of any of the following: opiates, benzodiazepines, Z-hypnotics
Measured: Within 2 weeks of admission
No. of possible side effects
No. possible side effects of any of the following: opiates, benzodiazepines, Z-hypnotics
Measured: Within 2 weeks of admission
No. of possible serious interactions
No. possible serious interactions of any of the following: opiates, benzodiazepines, Z-hypnotics
Measured: Within 2 weeks of admission
No.of inappropriate medications for elderly at admission
No.of inappropriate medications as defined by NORGEP criteria (Norwegian general practice criteria)
Measured: Within 2 weeks of admission
No.of inappropriate medications for elderly during in-hospital stay
No.of inappropriate medications as defined by NORGEP criteria
Measured: Within 2 weeks of admission
No.of inappropriate medications for elderly at discharge
No.of inappropriate medications as defined by NORGEP criteria
Measured: Within 2 weeks of admission
No.of inappropriate medications for elderly at admission
No.of inappropriate medications as defined by STOPP criteria (Screening tool of older patients prescriptions)
Measured: Within 2 weeks of admission
No.of inappropriate medications for elderly during in-hospital stay
No.of inappropriate medications as defined by STOPP criteria
Measured: Within 2 weeks of admission
No.of inappropriate medications for elderly at discharge
No.of inappropriate medications as defined by STOPP criteria
Measured: Within 2 weeks (index stay may in some cases be somewhat longer)
Substance use disorder
DSM-IV criteria assessed through additional questions to MINI interview
Measured: Within 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study start3 May 2017
- Primary completion1 Feb 2021
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- University Hospital, Akershus
- Sponsor type
- University, hospital or other
- Collaborators
- King's College London, University of Oslo
- Responsible party
- Principal investigator, Christofer Lundqvist, University Hospital, Akershus
- Investigators
- Jorunn Rugkåsa, PhD, Study director, Coordinator of overall research program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03162081
- Sponsor's protocol ID
- NRC256431WP2
- Status last verified
- Aug 2024
- First submitted
- 3 May 2017
- Last updated
- 4 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bjelkaroy MT, Simonsen TB, Siddiqui TG, Cheng S, Grambaite R, Benth JS, Lundqvist C. Mortality and health-related quality of life in older adults with long-term use of opioids, z-hypnotics or benzodiazepines: a prospective observational study at 5 years follow-up. BMJ Open. 2024 Feb 21;14(2):e079347. doi: 10.1136/bmjopen-2023-079347.
PubMed 38387984Bjelkaroy MT, Simonsen TB, Siddiqui TG, Halset S, Cheng S, Grambaite R, Benth JS, Gerwing J, Kristoffersen ES, Lundqvist C. Brief Intervention as a Method to Reduce Z-Hypnotic Use by Older Adults: Feasibility Case Series. JMIR Form Res. 2024 Feb 8;8:e51862. doi: 10.2196/51862.
PubMed 38329779Bjelkaroy MT, Benth JS, Simonsen TB, Siddiqui TG, Cheng S, Kristoffersen ES, Lundqvist C. Measuring pain intensity in older adults. Can the visual analogue scale and the numeric rating scale be used interchangeably? Prog Neuropsychopharmacol Biol Psychiatry. 2024 Mar 2;130:110925. doi: 10.1016/j.pnpbp.2023.110925. Epub 2023 Dec 22.
PubMed 38143014Siddiqui TG, Bjelkaroy MT, Cheng S, Kristoffersen ES, Grambaite R, Lundqvist C. The effect of cognitive function and central nervous system depressant use on mortality-A prospective observational study of previously hospitalised older patients. PLoS One. 2022 Mar 3;17(3):e0263024. doi: 10.1371/journal.pone.0263024. eCollection 2022.
PubMed 35239678Bjelkaroy MT, Cheng S, Siddiqui TG, Benth JS, Grambaite R, Kristoffersen ES, Lundqvist C. The association between pain and central nervous system depressing medication among hospitalised Norwegian older adults. Scand J Pain. 2021 Dec 16;22(3):483-493. doi: 10.1515/sjpain-2021-0120. Print 2022 Jul 26.
PubMed 34913326Siddiqui TG, Cheng S, Gossop M, Kristoffersen ES, Grambaite R, Lundqvist C. Association between prescribed central nervous system depressant drugs, comorbidity and cognition among hospitalised older patients: a cross-sectional study. BMJ Open. 2020 Jul 27;10(7):e038432. doi: 10.1136/bmjopen-2020-038432.
PubMed 32718926Cheng S, Siddiqui TG, Gossop M, Kristoffersen ES, Lundqvist C. Sociodemographic, clinical and pharmacological profiles of medication misuse and dependence in hospitalised older patients in Norway: a prospective cross-sectional study. BMJ Open. 2019 Sep 5;9(9):e031483. doi: 10.1136/bmjopen-2019-031483.
PubMed 31492795Cheng S, Siddiqui TG, Gossop M, Kristoffersen ES, Lundqvist C. The Severity of Dependence Scale detects medication misuse and dependence among hospitalized older patients. BMC Geriatr. 2019 Jun 24;19(1):174. doi: 10.1186/s12877-019-1182-3.
PubMed 31234786
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medication Misuse and Dependence in Elderly Patients
- ClinicalTrials.gov ID
- NCT03162081
- Acronym / sponsor ID
- NRC256431WP2
- Keywords
- addiction, cognition, impulsivity, neuropsychology, prescription drug misuse, dependence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Hospital, AkershusUniversity, hospital or other
- Collaborators
- King's College London, University of Oslo
- Study start
- 3 May 2017 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 22 May 2017 (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.
The project focuses on investigating problematic medication use, especially overuse of potentially addictive drugs among the elderly.
The investigators aim firstly to develop and validate instruments for detecting and describing behavioral aspects and consequences of dependence on, and misuse of, prescription medication among elderly.
In addition to evaluating diagnostic utility of screening instruments, the investigators aim to identify and report characteristics, risk factors and consequences of medication misuse and dependence among the elderly.
Detailed description
Elderly represent a particularly vulnerable group with many contributing factors including age-related multifactorial morbidity, cognitive function, polypharmacy, dependence and multiple prescribers with suboptimal communication. Centrally active pain killers and sedative/hypnotic medications give increased risk of addiction, adverse drug events, reduced physical and/or cognitive function.
The project comprises diagnostic accuracy, descriptive screening, cross-sectional and case-control studies, with aims to: i) assess diagnostic utility of instruments for elderly patients; ii) describe risk factors for medication misuse and dependence; iii) describe consequences of the use of centrally active medications among elderly compared to a control population.
Moreover, the investigators aim to examine the association between medication misuse and changes in cognitive function, focusing on deficits in specific domains of cognition. An additional aim is to explore the possibility of dissociating such cognitive changes from other causes of mild cognitive impairment (MCI) associated with development of dementia.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Users | – | Diagnostic Test: Substance misuse screening, Diagnostic Test: EQ-5D, Diagnostic Test: Impulsivity screening, Diagnostic Test: Cognitive screening, Diagnostic Test: Functional tests, Diagnostic Test: Cognistat, Diagnostic Test: Neuropsychological profiling, Other: Clinical interview, Other: Medication use, Other: ComorbidityElderly patients who use prescription benzodiazepines/Z-hypnotics or opiates Clinical interview, Substance misuse screening, EuroQol five dimensional health-related quality of life questionnaires (EQ-5D), Impulsivity screening, Cognitive screening, Functional tests, Cognistat Neurobehavioural cognitive status examination (Cognistat), Neuropsychological profiling, Medication use, Comorbidity |
| Non-users | – | Diagnostic Test: Substance misuse screening, Diagnostic Test: EQ-5D, Diagnostic Test: Impulsivity screening, Diagnostic Test: Cognitive screening, Diagnostic Test: Functional tests, Diagnostic Test: Cognistat, Diagnostic Test: Neuropsychological profiling, Other: Clinical interview, Other: Medication use, Other: ComorbidityAge and gender matched controls not using the above Clinical interview, Substance misuse screening, EuroQol five dimensional health-related quality of life questionnaires (EQ-5D), Impulsivity screening, Cognitive screening, Functional tests, Cognistat Neurobehavioural cognitive status examination (Cognistat), Neuropsychological profiling, Medication use, Comorbidity |
| Screening group | – | Diagnostic Test: Substance misuse screening, Diagnostic Test: EQ-5D, Diagnostic Test: Impulsivity screening, Diagnostic Test: Cognitive screening, Diagnostic Test: Functional tests, Other: Clinical interview, Other: Medication use, Other: ComorbidityPatients over 65 admitted to hospital as in-patients Clinical interview, Substance misuse screening, EuroQol five dimensional health-related quality of life questionnaires (EQ-5D), Impulsivity screening, Cognitive screening, Functional tests, Medication use, Comorbidity |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- All admitted elderly 65-90 years of age are screened, for case-control age and gender-matched pairs of Users and non-users will in addition be examined in depth with neuropsychological tests
Key inclusion criteria (1 listed)
- Admitted to geriatric or Neurology dept of hospital during inclusion time
Key exclusion criteria (8 listed)
- MMSE < 21,
- diagnosis of pre-existing severe depression or psychotic disease,
- pre-existing dementia diagnosis,
- new pain requiring start-up of central pain killers not previously used,
- Palliative treatment.
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 |
|---|---|---|
| Substance misuse screeningDiagnostic and Statistical manual of mental disorders, version 4 (DSM-IV)/MINI-international Neuropsychiatric interview (MINI interview) for Diagnostics of dependence, additional questions for DSM-V classification, severity of dependence scale (SDS) | Diagnostic test | Non-users, Screening group, Users |
| EQ-5DHealth related Quality of life | Diagnostic test | Non-users, Screening group, Users |
| Impulsivity screeningBarratts impulsivity test v. 11, Behavioural inhibition/behavioural activation test | Diagnostic test | Non-users, Screening group, Users |
| Cognitive screeningMinimental state examination (MMSE), Hospital anxiety and depression scale (HADS), Trail-making test, clock drawing test | Diagnostic test | Non-users, Screening group, Users |
| Functional testsTimed up and go (TUG), Single leg balancing test (SLB) | Diagnostic test | Non-users, Screening group, Users |
| CognistatAssessment of cognitive domains | Diagnostic test | Non-users, Users |
| Neuropsychological profilingControlled Oral Word Association Test, Categorical fluency tests, Wechsler Adult Intelligence Scale, Color-Word Interference Test (CWIT) from the Delis-Kaplan Executive Function test | Diagnostic test | Non-users, Users |
| Clinical interviewInterview for sociodemographics, utilisation of health care, economic varables, The De Jong Gierveld Loneliness Scale | Other | Non-users, Screening group, Users |
| Medication useDetailed screen of used medications, interactions, side effects in electronic patient registry | Other | Non-users, Screening group, Users |
| ComorbidityCharlson comorbidity index and Cumulated illness rating scale (CIRS) based on electronic patient registry | Other | Non-users, Screening group, Users |
Primary outcome
Dependence y/n
Time frame: Within 2 weeks of admission
DSM-IV defined substance dependence assessed by MINI interview
Medication misuse y/n
Time frame: Past year prior to in-hospital stay (data collected within 2 weeks of admission)
Use of any of: opiates/benzodiazepine/Z-hypnotics >5 days per week for >3 months
20 secondary outcomes
MCI - Mild cognitive impairment
Time frame: Within 2 weeks of admission
MMSE
Time frame: Within 2 weeks of admission
COGNISTAT
Time frame: Within 2 weeks of admission
EQ-5D
Time frame: Within 2 weeks of admission
BIS-11
Time frame: Within 2 weeks of admission
BIS/BAS score
Time frame: Within 2 weeks of admission
TUG
Time frame: Within 2 weeks of admission
SLB
Time frame: Within 2 weeks of admission
Neuropsychological profiles
Time frame: Within 2 weeks of admission
Use of addictive medication y/n
Time frame: Within 2 weeks of admission
No of days of use of defined addictive medications/month
Time frame: Within 2 weeks of admission
No. of possible side effects
Time frame: Within 2 weeks of admission
No. of possible serious interactions
Time frame: Within 2 weeks of admission
No.of inappropriate medications for elderly at admission
Time frame: Within 2 weeks of admission
No.of inappropriate medications for elderly during in-hospital stay
Time frame: Within 2 weeks of admission
No.of inappropriate medications for elderly at discharge
Time frame: Within 2 weeks of admission
No.of inappropriate medications for elderly at admission
Time frame: Within 2 weeks of admission
No.of inappropriate medications for elderly during in-hospital stay
Time frame: Within 2 weeks of admission
No.of inappropriate medications for elderly at discharge
Time frame: Within 2 weeks (index stay may in some cases be somewhat longer)
Substance use disorder
Time frame: Within 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2024.
- Derived from this study: PubMed 38387984Bjelkaroy MT, Simonsen TB, Siddiqui TG, Cheng S, Grambaite R, Benth JS, Lundqvist C. Mortality and health-related quality of life in older adults with long-term use of opioids, z-hypnotics or benzodiazepines: a prospective observational study at 5 years follow-up. BMJ Open. 2024 Feb 21;14(2):e079347. doi: 10.1136/bmjopen-2023-079347.
- Derived from this study: PubMed 38329779Bjelkaroy MT, Simonsen TB, Siddiqui TG, Halset S, Cheng S, Grambaite R, Benth JS, Gerwing J, Kristoffersen ES, Lundqvist C. Brief Intervention as a Method to Reduce Z-Hypnotic Use by Older Adults: Feasibility Case Series. JMIR Form Res. 2024 Feb 8;8:e51862. doi: 10.2196/51862.
- Derived from this study: PubMed 38143014Bjelkaroy MT, Benth JS, Simonsen TB, Siddiqui TG, Cheng S, Kristoffersen ES, Lundqvist C. Measuring pain intensity in older adults. Can the visual analogue scale and the numeric rating scale be used interchangeably? Prog Neuropsychopharmacol Biol Psychiatry. 2024 Mar 2;130:110925. doi: 10.1016/j.pnpbp.2023.110925. Epub 2023 Dec 22.
- Derived from this study: PubMed 35239678Siddiqui TG, Bjelkaroy MT, Cheng S, Kristoffersen ES, Grambaite R, Lundqvist C. The effect of cognitive function and central nervous system depressant use on mortality-A prospective observational study of previously hospitalised older patients. PLoS One. 2022 Mar 3;17(3):e0263024. doi: 10.1371/journal.pone.0263024. eCollection 2022.
- Derived from this study: PubMed 34913326Bjelkaroy MT, Cheng S, Siddiqui TG, Benth JS, Grambaite R, Kristoffersen ES, Lundqvist C. The association between pain and central nervous system depressing medication among hospitalised Norwegian older adults. Scand J Pain. 2021 Dec 16;22(3):483-493. doi: 10.1515/sjpain-2021-0120. Print 2022 Jul 26.
- Derived from this study: PubMed 32718926Siddiqui TG, Cheng S, Gossop M, Kristoffersen ES, Grambaite R, Lundqvist C. Association between prescribed central nervous system depressant drugs, comorbidity and cognition among hospitalised older patients: a cross-sectional study. BMJ Open. 2020 Jul 27;10(7):e038432. doi: 10.1136/bmjopen-2020-038432.
- Derived from this study: PubMed 31492795Cheng S, Siddiqui TG, Gossop M, Kristoffersen ES, Lundqvist C. Sociodemographic, clinical and pharmacological profiles of medication misuse and dependence in hospitalised older patients in Norway: a prospective cross-sectional study. BMJ Open. 2019 Sep 5;9(9):e031483. doi: 10.1136/bmjopen-2019-031483.
- Derived from this study: PubMed 31234786Cheng S, Siddiqui TG, Gossop M, Kristoffersen ES, Lundqvist C. The Severity of Dependence Scale detects medication misuse and dependence among hospitalized older patients. BMC Geriatr. 2019 Jun 24;19(1):174. doi: 10.1186/s12877-019-1182-3.
- Individual participant dataSharing planned: No
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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.
Jorunn Rugkåsa, PhD study director
Coordinator of overall research program
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 Mild Cognitive Impairment and Elderly, run by University Hospital, Akershus 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 8 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 4 Sep 2024. 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?
Dependence y/n (time frame: Within 2 weeks of admission). 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 NCT03162081, which also lists 8 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 4 Sep 2024; AzTrials last refreshed its copy on 27 Oct 2026.