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Addiction Disorders in Adolescence- Underlying Pathomechanisms and Treatment Evaluation

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ClinicalTrials.gov Identifier: NCT03444974
Recruitment Status : Not yet recruiting
First Posted : February 26, 2018
Last Update Posted : August 15, 2018
Sponsor:
Information provided by (Responsible Party):
Technische Universität Dresden

Brief Summary:

This study aims to investigate sociodemographic background of youth drug abuse, as well as psychiatric comorbidities with the help of self-report questionnaires and structured diagnostic interviews. The study simultaneously intends to evaluate long term cortisol levels in a single hair sample. Furthermore, three intravenous blood samples will be obtained from each participant in the course of the treatment in order to investigate substance related changes in immune and stress Systems, as well as methylation based changes associated with vulnerability and dependency.

As the efficacy of currently available treatment options for addiction disorders is still unacceptably low, our study also aims to adapt, apply and evaluate new methods of treatment, such as a an adapted short term Matrix therapy for adolescents suffering from addiction disorders and their parents. Therapy outcomes, parental stress levels and learned skills will be evaluated.


Condition or disease Intervention/treatment Phase
Drug Abuse and Dependency Adolescent Behavior Other: adapted treatment according to the Matrix therapy Not Applicable

Detailed Description:

As numbers of youth drug abuse have grown rapidly within the last couple of years, research on youth drug abuse and dependency has taken a new and vital role within the public healthcare system. For this reason, it is crucial to find new ways to effectively integrate adolescent patients into the health care system, as well as assign them to treatment options tailor made for the specific challenges and needs of this population. This study aims to investigate (a) sociodemographic background and psychiatric comorbidities in connection with youth drug abuse and dependency to enhance understanding of epidemiologic risk factors for developing drug dependency in adolescence, as well as benefit future treatment options. It further aims to investigate (b) molecular and epigenetic mechanisms of addiction disorders in adolescents by analyzing methylation pattern, as well as proteome analysis of peripheral immune markers. The investigator's aim is a better understanding of the multimodal biological underpinnings of risk/resilience for addiction in youth on the molecular, cellular and circuit levels with a special focus on the changes within the stress and immune system in patients with addiction disorders and their family members.

Another research interest of this study concerns (c) adapting and evaluating new treatment options, tailor made for the adolescent population. For this reason the investigators aim to adapt, implement and evaluate a therapeutic program according to the Matrix model for the treatment of substance abuse, which consists of two group therapies for patients, as well as their parents (Evaluation time points: T0, T1, T2 and T3). Last, this study aims to (d) evaluate parental stress levels, parental communication skills and knowledge in connection with youth drug abuse.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Symptom reduction in the treatment group (adolescent patients with substance abuse and dependency) in comparison to age and gender matched waiting-list and healthy controls. Changes in stress levels, problem solving and communication skills of parents in the treatment group in comparison to waiting-list parents.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Addiction Disorders in Adolescence- Underlying Pathomechanisms and Treatment Evaluation
Estimated Study Start Date : August 2018
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2021

Arm Intervention/treatment
Active Comparator: Patient therapy group
  • Adolescents with drug abuse and dependency problems
  • Receiving an adapted treatment according to the Matrix therapy
Other: adapted treatment according to the Matrix therapy
cognitive and behavioral treatment of drug abuse/dependency issues, as well as connected parameters

Active Comparator: Parental therapy group
  • Parents of adolescents with drug abuse problems
  • Receiving an adapted treatment according to the Matrix therapy
Other: adapted treatment according to the Matrix therapy
cognitive and behavioral treatment of drug abuse/dependency issues, as well as connected parameters

No Intervention: Patient waiting list group
  • Adolescents with drug abuse and dependency problems
  • On the waiting list for receiving a Matrix therapy treatment
No Intervention: Parental waiting list group
  • Parents of adolescents with drug abuse problems
  • On the waiting list for receiving a Matrix therapy treatment
No Intervention: control group
  • Adolescents with no history of or current drug abuse or dependency
  • no other intake of psychotropic substances such as psychotropic medication



Primary Outcome Measures :
  1. Sociodemographic data- Highest Education [ Time Frame: Single baseline data collection ]
    Sociodemographic background of adolescents with substance abuse and dependency: Collection of data about highest education. Measured in options primary school/ currently in high school/ dropped out of school/ finished compulsory school/ finished apprenticeship/ currently doing apprenticeship

  2. Sociodemographic data- Gender [ Time Frame: Single baseline data collection ]
    Sociodemographic background of adolescents with substance abuse and dependency: Collection of data about gender. Measured in options female/ male /other (asks for specification)

  3. Sociodemographic data- Migration background [ Time Frame: Single baseline data collection ]
    Sociodemographic background of adolescents with substance abuse and dependency: Collection of data about migration background. Measured in options no/ yes (asks for specification)

  4. Sociodemographic data- Civil status [ Time Frame: Single baseline data collection ]
    Sociodemographic background of adolescents with substance abuse and dependency: Collection of data about the relationship status. Measured in options single/ married/ separated/ divorced/ widowed/ civil union/ domestic partnership/ other (asks for specification)

  5. Sociodemographic data- Nationality [ Time Frame: Single baseline data collection ]
    Sociodemographic background of adolescents with substance abuse and dependency: Collection of data about nationality. Measured in options German/ other (asks for specification)

  6. Sociodemographic data- Age [ Time Frame: Single baseline data collection ]
    Sociodemographic background of adolescents with substance abuse and dependency: Collection of data about age. Measured in years.

  7. Parental report of emotional, behavioral and social problems- Child Behavior Checklist [ Time Frame: Baseline data collection ]
    Emotional, behavioral and social problems associated with adolescents with substance abuse and dependency: Data collection of existence of emotional/behavioral/social problems with help of the Child Behavior Checklist (CBCL). Measured in a person's scoring on 8 different scales (anxious/depressed, withdrawn/depressed, somatic complaints, social problems, thought problems, attention problems, rule-breaking behavior, aggressive behavior) as well as a total score.

  8. Self-report of emotional, behavioral and social problems- Youth Self-Report [ Time Frame: Baseline data collection ]
    Emotional, behavioral and social problems associated with adolescents with substance abuse and dependency: Data collection of existence of emotional/behavioral/social problems with help of the Youth Self-Report (YSR). Measured in a person's scoring on 8 different scales (anxious/depressed, withdrawn/depressed, somatic complaints, social problems, thought problems, attention problems, rule-breaking behavior, aggressive behavior) as well as a total score.

  9. Psychiatric comorbidities- Satisfaction With Life Scale [ Time Frame: Baseline data collection ]
    Psychiatric comorbidities associated with adolescents with substance abuse and dependency: Data collection with help of the Satisfaction With Life Scale (SWLS). The scale is designed to measure global cognitive judgments of one's life satisfaction with help of 5 items using a 7-point scale that ranges from 7 strongly agree to 1 strongly disagree. Scoring benchmarks: extremely dissatisfied (5-9), dissatisfied (10-14), slightly dissatisfied (15-19), neutral (20), slightly satisfied (21-25), satisfied (26-30), extremely satisfied (31-35).

  10. Psychiatric comorbidities- Beck Depression Inventory [ Time Frame: Baseline data collection ]
    Psychiatric comorbidities associated with adolescents with substance abuse and dependency: Data collection with help of the Beck Depression Inventory (BDI-II). Measured in a test persons's scoring number on the scale.

  11. Mental distress- Brief Symptom Checklist [ Time Frame: Baseline data collection ]
    Psychiatric comorbidities associated with adolescents with substance abuse and dependency: Data collection with help of the Brief Symptom Checklist (BSCL). Current amount of mental distress is measured in a person's numerical global severity index.

  12. Psychiatric comorbidities- MINI-Kid [ Time Frame: Baseline data collection ]
    Psychiatric comorbidities associated with adolescents with substance abuse and dependency: Data collection with help of the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI Kid), a structured diagnostic interview. Measured in positive or negative answers.

  13. Molecular and epigenetic changes visible in cortisol [ Time Frame: Baseline data collection- Measured at one single point right when a person enters the study. ]
    Measuring cortisol in a single hair sample. Measured in ng/ml.

  14. Molecular and epigenetic changes visible in methylation pattern [ Time Frame: Baseline data collection- Measured at one single point right when a person enters the study. ]
    Measuring methylation pattern in a single blood sample. Measured in %.

  15. Molecular and epigenetic changes visible in immune markers [ Time Frame: Baseline data collection- Measured at one single point right when a person enters the study. ]
    Investigating immune marker Interleukin-6 in a single blood sample. Measured in ng/ml.

  16. Short term therapy efficacy [ Time Frame: Data collection at 2 points, baseline prior therapy and 3 months after a test person has completed therapy ]
    Evaluation of therapy efficiency based on existing/non-existing relapse until 3 months after therapy with help of either positive/negative drug screenings.

  17. Long term therapy efficacy [ Time Frame: Data collection at 2 points, baseline prior therapy and 6 months after a test person has completed therapy ]
    Evaluation of therapy efficiency based on existing/non-existing relapse until 6 months after therapy with help of either positive/negative drug screenings.

  18. Change from baseline DUDIT score at 3 months after therapy [ Time Frame: Data collection at 2 points, baseline prior therapy and 3 months after a test person has completed therapy ]
    Evaluation of therapy efficiency via Drug Use Disorders Identification Test (DUDIT). Change from baseline DUDIT score at 3 months after therapy is being assessed. Measured in a test persons's scoring number on the DUDIT scale.

  19. Change from baseline DUDIT addiction score at 6 months after therapy [ Time Frame: Data collection at 3 points, baseline prior therapy and 6 months after a test person has completed therapy ]
    Evaluation of therapy efficiency via DUDIT. Change from baseline DUDIT score at 6 months after therapy is being assessed. Measured in a test persons's scoring number on the DUDIT scale.

  20. Change from baseline parenting skills at 3 months after therapy [ Time Frame: Data collection at 2 points, baseline prior therapy and 3 months after a parental test person has completed therapy ]
    Data collection of parenting skills (communication skills) via descriptive self-reports. Change from baseline parenting skills at 3 months after therapy is being assessed. Measured in self-reported description of change.

  21. Change from baseline parenting skills at 6 months after therapy [ Time Frame: Data collection at 2 points, baseline prior therapy and 6 months after a parental test person has completed therapy ]
    Data collection of parenting skills (communication skills) via descriptive self-reports. Change from from baseline parenting skills at 6 months after therapy is being assessed. Measured in self-reported description of change.

  22. Change from baseline parental stress level at 3 months after therapy- Parent Stress Scale [ Time Frame: Data collections at 2 points, baseline prior therapy and 3 months after a test person has completed therapy ]
    Data collection of change from baseline parent stress level at 3 months is being assessed via a German questionnaire assessing the amount of parental stress (ESF). Stress factors within everyday parent life are being measured with help of 38 items, which are being scored on a 4-point scale that ranges from 0(disagree) to 3 (completely agree). All items can be assigned to 4 different areas of stress, being social support (7 items, total score 0-21 points), workload and restrictions (7 items, total score 0-21 points), social support (7 items, total score 0-21 points) and cooperative partnership (7 items, total score 0-21). High scores report high stress levels.

  23. Change from baseline parental stress level at 6 months after therapy- Parent Stress Scale [ Time Frame: Data collections at 2 points, baseline prior therapy and 6 months after a test person has completed therapy ]
    Data collection of change from baseline parent stress level at 6 months is being assessed via a German questionnaire assessing the amount of parental stress (ESF). Stress factors within everyday parent life are being measured with help of 38 items, which are being scored on a 4-point scale that ranges from 0(disagree) to 3 (completely agree). All items can be assigned to 4 different areas of stress, being social support (7 items, total score 0-21 points), workload and restrictions (7 items, total score 0-21 points), social support (7 items, total score 0-21 points) and cooperative partnership (7 items, total score 0-21). High scores report high stress levels.



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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Matrix therapy group and waiting list patients:

Inclusion Criteria:

  • continuous substance abuse for at least 6 months or more (at one point in life)
  • Age 12,00-17,11

Exclusion Criteria:

  • Preexisting neurological diseases
  • Diseases of or with involvement of the central nervous system
  • Intelligence quotient (IQ) < 70
  • Diseases concerning the adrenal gland, pituitary gland or hypothalamus
  • Acute viral diseases during T0, T1, T2, T3

Control group:

Inclusion Criteria:

  • Age 12,00-17,11
  • No history of substance abuse

Exclusion Criteria:

  • Preexisting neurological diseases
  • Psychiatric disorders
  • Diseases of or with involvement of the central nervous system (CNS)
  • CNS modulating drug intake
  • IQ < 70
  • Substance abuse
  • Diseases concerning the adrenal gland, pituitary gland or hypothalamus
  • Acute viral diseases during T0, T1, T2, T3
  • psychotropic drug intake

Parental therapy group and waiting list group:

Inclusion Criteria:

  • At least one child/protégé with problematic substance abuse
  • No current substance abuse on their own
  • at least one parent must be eligible to participate in the group

Exclusion Criteria:

  • current drug abuse

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03444974


Contacts
Contact: Lisa Klamert, MSc. +49 (0)351 458-7601 lisa.klamert@uniklinikum-dresden.de
Contact: Yulia Golub, Dr.rer.nat. +49 (0)351 458-7601 yulia.golub@uniklinikum-dresden.de

Locations
Germany
Youth Drug Outpatient Department of the C.G.C. University Hospital Dresden Not yet recruiting
Dresden, Saxony, Germany, 01307
Sponsors and Collaborators
Technische Universität Dresden
Investigators
Study Director: Veit Roessner, Prof.Dr.med. Technische Universität Dresden, Universitätsklinikum C.G.C. Dresden

Publications:

Responsible Party: Technische Universität Dresden
ClinicalTrials.gov Identifier: NCT03444974     History of Changes
Other Study ID Numbers: Matrix_UKD
First Posted: February 26, 2018    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Technische Universität Dresden:
drugs
youth
adolescence
abuse
dependency
Tetrahydrocannabinol (THC)
Methamphetamine (Crystal Meth)
Marihuana
comorbidity
treatment
etiopathology
sociodemographics
Saxony

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders