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Substance Use in Elderly Individuals: Brain and Cognitive Correlates and the Effect of Psychotherapy

Primary Purpose

Substance Use Disorder

Status

Terminated

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

TIQAAM_therapy

Psychoeducation

About this trial

This is an interventional treatment trial for Substance Use Disorder

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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)

Exclusion Criteria:

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)
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")

Sites / Locations

Gerontopsychiatrisches Zentrum Hegibach

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TIQAAM_therapy

active_control

Arm Description

Individuals in this group will receive units from the TIQAAM treatment program

Individuals in this group will receive units of psychoeducation

Outcomes

Primary Outcome Measures

change in the total score of the Hospital Anxiety and Depression Scale - German version (HADS-D)

Secondary Outcome Measures

Full Information

NCT ID

NCT02835144

First Posted

July 13, 2016

Last Updated

November 20, 2017

Sponsor

Prof. Dr. med. Egemen Savaskan

1. Study Identification

Unique Protocol Identification Number

NCT02835144

Brief Title

Substance Use in Elderly Individuals: Brain and Cognitive Correlates and the Effect of Psychotherapy

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Terminated

Why Stopped

Personnel changes; insufficient resources to continue

Study Start Date

February 2, 2017 (Actual)

Primary Completion Date

November 15, 2017 (Actual)

Study Completion Date

November 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Prof. Dr. med. Egemen Savaskan

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Substance Use Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TIQAAM_therapy

Arm Type

Experimental

Arm Description

Individuals in this group will receive units from the TIQAAM treatment program

Arm Title

active_control

Arm Type

Active Comparator

Arm Description

Individuals in this group will receive units of psychoeducation

Intervention Type

Other

Intervention Name(s)

TIQAAM_therapy

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Psychoeducation

Intervention Description

This intervention is a psychoeducation module pertaining to substance use disorders.

Primary Outcome Measure Information:

Title

change in the total score of the Hospital Anxiety and Depression Scale - German version (HADS-D)

Time Frame

210 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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) Exclusion Criteria: 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) 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")

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Egemen Savaskan, Prof. Dr. med.

Organizational Affiliation

Klinik für Alterspsychiatrie

Official's Role

Principal Investigator

Facility Information:

Facility Name

Gerontopsychiatrisches Zentrum Hegibach

City

Zürich

ZIP/Postal Code

8032

Country

Switzerland

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Substance Use in Elderly Individuals: Brain and Cognitive Correlates and the Effect of Psychotherapy

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