Substance Use DisorderNCT02835144
Substance Use in Elderly Individuals: Brain and Cognitive Correlates and the Effect of Psychotherapy
A study testing TIQAAM_therapy and Psychoeducation in people with Substance Use Disorder, run by Prof. Dr. med. Egemen Savaskan at 1 site in Switzerland.
Trial summary
The prevalence of addictive disorders in old age is increasing. Age specific and appropriate therapeutic concepts tailored to in-patients thus represent a promising approach for the future. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Substance Use Disorder
- What is being tested?
- TIQAAM_therapy and Psychoeducation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSwitzerland
- Study dates
- 2 Feb 2017to 15 Nov 2017
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Subjects aged 65 or above with, according to WHO-ASSIST V3.0, a hazardous consumption of alcoholic beverages and / or benzodiazepines and / or non-benzodiazepine hypnotics (zolpidem, zopiclone, zaleplon)
- The subjects must be able to understand verbal and written information about the study flow and content and to give their written consent.
- The subjects must be able to understand and perform verbal and written tasks (cognitive tests / questionnaires)
Who cannot join
- Taking medication that could affect cognition outside of benzodiazepines and / or non-benzodiazepine hypnotics (zolpidem, zopiclone, zaleplon).
- Drug treatments with anxiolytics (benzodiazepines) as part of an ongoing drug-assisted detoxification
- Taking antidepressant medication
- Taking sleep-inducing substances (for example Dipiperon®, Trittico®, Valverde Sleep® or Valverde Entspannung®)
- Taking other anxiolytic active substances (for example, pregabalin, Opipramol). The use of medication is allowed to treat somatic diseases.
- Use of drugs or substance dependence. Except for alcohol, benzodiazepines and non-benzodiazepine hypnotics (zolpidem, zopiclone, zaleplon)
Show all 15Show fewer
- Diseases which prevent the subject from giving consent for this study or which impair cooperation in the investigation.
- Severe and / or unstable physical illness: severe depression, severe mania, delirium, severe cognitive impairment (mini-mental status test < 20/30 points), dementia of the Alzheimer type or other dementias, multiple sclerosis, clinically manifest structural brain damage (eg cerebral hemorrhage, brain tumors, MRI findings by Schulthess clinic)
- Heavily impaired vision and eye diseases
- Additional exclusion criteria for part 2 of the study:
- Pacemaker, implantable cardioverter defibrillator (ICD), neurostimulator, aneurysm clip, prosthetic heart valve, valve prosthesis, metal prosthesis
- Clips after surgery, metallic bone plates, artificial joints, metal fragments in the body, professional in the metal processing industry, non-removable piercing, ferruginous tattoo ink
- Pregnancy
- Claustrophobia
- Use of alcohol or other consciousness-altering substances within 24 hours prior to the MRI scan (exceptions: see "exclusion criteria")
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised Monocentric Clinical Study for the Identification of Cognitive and Neuroanatomical Alterations and for the Evaluation of the Efficacy of a Psychotherapeutic Intervention in Individuals With Risky Consumption of Alcohol and/or Sedative Drugs Aged ≥ 65 Years
The prevalence of addictive disorders in old age is increasing. Age specific and appropriate therapeutic concepts tailored to in-patients thus represent a promising approach for the future. The investigated therapeutic intervention is a "therapy program for integrated qualified acute treatment of alcohol and drug problems" (TIQAAM).
Read the detailed description
The prevalence of addictive disorders in old age is increasing. Age specific and appropriate therapeutic concepts tailored to inpatients thus represent a promising approach for the future. The investigated therapeutic intervention is a "therapy program for integrated qualified acute treatment of alcohol and drug problems" (TIQAAM).
Subjects ≥ 65 years, in which according to the WHO ASSIST V3.0 a risky consumption of alcoholic beverages, or benzodiazepines / non-benzodiazepine hypnotics (zolpidem, zopiclone, zaleplon), or both, are examined before and after a psychotherapeutic intervention during their inpatient stay exists. The data collected in part 1 of the study pertain to social integration, the motivation to change, quality of life in old age, general psychiatric symptoms. The data collected in part 2 of the study pertain to brain structure and functions. Data from standard procedures will be correlated to the data above.These relate to psychiatric symptoms, past consumption behavior, cognitive abilities, perceived social support and risk appetite.
- Conditions
- Substance Use Disorder
- Being tested
- TIQAAM_therapy, Psychoeducation
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TIQAAM_therapyOther
The treatment program consists of TIQAAM therapy blocks to three priority areas: promoting change and motivation, relapse prevention and relapse management, and promote resource and euthymic activities to increase the abstinence motivation. The TIQAAM is based on behavioral approaches as well as motivational interviewing of Miller and Rollnick.
PsychoeducationOther
This intervention is a psychoeducation module pertaining to substance use disorders.
| Study group | Role | What they receive |
|---|---|---|
| TIQAAM_therapy | Experimental | Individuals in this group will receive units from the TIQAAM treatment program Receives: Other: TIQAAM_therapy |
| active_control | Active comparator | Individuals in this group will receive units of psychoeducation Receives: Other: Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in the total score of the Hospital Anxiety and Depression Scale - German version (HADS-D)
Measured: 210 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2016 (estimated)
- Study start2 Feb 2017
- Primary completion15 Nov 2017
- Study completion15 Nov 2017
Why it stopped: Personnel changes; insufficient resources to continue
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisorderStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. med. Egemen Savaskan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Dr. med. Egemen Savaskan, Psychiatric University Hospital, Zurich
- Investigators
- Egemen Savaskan, Prof. Dr. med., Principal investigator, Klinik für Alterspsychiatrie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02835144
- Sponsor's protocol ID
- KNVRKAS - 2016-00210
- Status last verified
- Nov 2017
- First submitted
- 13 Jul 2016
- Last updated
- 21 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Monocentric Clinical Study for the Identification of Cognitive and Neuroanatomical Alterations and for the Evaluation of the Efficacy of a Psychotherapeutic Intervention in Individuals With Risky Consumption of Alcohol and/or Sedative Drugs Aged ≥ 65 Years
- ClinicalTrials.gov ID
- NCT02835144
- Acronym / sponsor ID
- KNVRKAS - 2016-00210
- Conditions
- Substance Use Disorder
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Personnel changes; insufficient resources to continue
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Prof. Dr. med. Egemen SavaskanUniversity, hospital or other
- Study start
- 2 Feb 2017 (actual)
- Primary completion
- 15 Nov 2017 (actual)
- Study completion
- 15 Nov 2017 (actual)
- First posted
- 15 Jul 2016 (estimated)
- 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 prevalence of addictive disorders in old age is increasing. Age specific and appropriate therapeutic concepts tailored to in-patients thus represent a promising approach for the future. The investigated therapeutic intervention is a "therapy program for integrated qualified acute treatment of alcohol and drug problems" (TIQAAM).
Detailed description
The prevalence of addictive disorders in old age is increasing. Age specific and appropriate therapeutic concepts tailored to inpatients thus represent a promising approach for the future. The investigated therapeutic intervention is a "therapy program for integrated qualified acute treatment of alcohol and drug problems" (TIQAAM).
Subjects ≥ 65 years, in which according to the WHO ASSIST V3.0 a risky consumption of alcoholic beverages, or benzodiazepines / non-benzodiazepine hypnotics (zolpidem, zopiclone, zaleplon), or both, are examined before and after a psychotherapeutic intervention during their inpatient stay exists. The data collected in part 1 of the study pertain to social integration, the motivation to change, quality of life in old age, general psychiatric symptoms. The data collected in part 2 of the study pertain to brain structure and functions. Data from standard procedures will be correlated to the data above.These relate to psychiatric symptoms, past consumption behavior, cognitive abilities, perceived social support and risk appetite.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TIQAAM_therapy | Experimental | Other: TIQAAM_therapyIndividuals in this group will receive units from the TIQAAM treatment program |
| active_control | Active comparator | Other: PsychoeducationIndividuals in this group will receive units of psychoeducation |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Subjects aged 65 or above with, according to WHO-ASSIST V3.0, a hazardous consumption of alcoholic beverages and / or benzodiazepines and / or non-benzodiazepine hypnotics (zolpidem, zopiclone, zaleplon)
- The subjects must be able to understand verbal and written information about the study flow and content and to give their written consent.
- The subjects must be able to understand and perform verbal and written tasks (cognitive tests / questionnaires)
Key exclusion criteria (15 listed)
- Taking medication that could affect cognition outside of benzodiazepines and / or non-benzodiazepine hypnotics (zolpidem, zopiclone, zaleplon).
- Drug treatments with anxiolytics (benzodiazepines) as part of an ongoing drug-assisted detoxification
- Taking antidepressant medication
- Taking sleep-inducing substances (for example Dipiperon®, Trittico®, Valverde Sleep® or Valverde Entspannung®)
- Taking other anxiolytic active substances (for example, pregabalin, Opipramol). The use of medication is allowed to treat somatic diseases.
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 |
|---|---|---|
| TIQAAM_therapyThe treatment program consists of TIQAAM therapy blocks to three priority areas: promoting change and motivation, relapse prevention and relapse management, and promote resource and euthymic activities to increase the abstinence motivation. The TIQAAM is based on behavioral approaches as well as motivational interviewing of Miller and Rollnick. | Other | TIQAAM_therapy |
| PsychoeducationThis intervention is a psychoeducation module pertaining to substance use disorders. | Other | active_control |
Primary outcome
change in the total score of the Hospital Anxiety and Depression Scale - German version (HADS-D)
Time frame: 210 days
Results and safety
The study was stopped early (reason given: Personnel changes; insufficient resources to continue). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2017.
- Individual participant dataSharing planned: Undecided
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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.
Egemen Savaskan, Prof. Dr. med. principal investigator
Klinik für Alterspsychiatrie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TIQAAM_therapy and Psychoeducation in people with Substance Use Disorder, run by Prof. Dr. med. Egemen Savaskan at 1 site in Switzerland.
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 3 inclusion and 15 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: stopped early, as of the sponsor's last update on 21 Nov 2017. 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 Switzerland. 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?
The study was stopped early (reason given: Personnel changes; insufficient resources to continue). 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?
change in the total score of the Hospital Anxiety and Depression Scale - German version (HADS-D) (time frame: 210 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Nov 2017.