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Clinical Trials/NCT03444974
NCT03444974
Unknown
Not Applicable

Addiction and Substance Dependence in Adolescence - Neurobiological Pathomechanisms and Treatment Evaluation

Technische Universität Dresden1 site in 1 country450 target enrollmentAugust 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Substance Use Disorders
Sponsor
Technische Universität Dresden
Enrollment
450
Locations
1
Primary Endpoint
Aim 1: Sociodemographic background
Last Updated
7 years ago

Overview

Brief Summary

This study aims to investigate the sociodemographic background as well as psychiatric comorbidities of adolescent substance users with substance use disorders. The study simultaneously evaluates biomarkers of stress and addiction, including long-term cortisol levels from hair samples and gene methylation in blood samples associated with substance use.

Our study also adapts, rolls out, and evaluates an evaluated multimodal treatment manual wich was originally intended for stimulant drug users (MATRIX). We adopt this manual to the needs and specifics of adolescents (MATRIX-A, A=adolescents) with substance use disorders of any substance, including cannabis, methamphetamine, and alcohol. Adolescents will receive group therapy sessions, individual therapy sessions, and medication if needed, while parents or professional caretaker will receive group sessions. Therapy outcomes will be examined in addition to parental distress and parenting skills.

Detailed Description

As numbers of adolescent 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 adolescent substance abuse and dependence 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 manual for the treatment of substance abuse, which consists of two group therapies for patients, as well as their parents (Evaluation time points: T0, T1, and T2). Last, this study aims to (d) evaluate parental stress levels, parental communication skills and knowledge in connection with adolescent substance abuse.

Registry
clinicaltrials.gov
Start Date
August 1, 2018
End Date
December 31, 2021
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age 12.00-17.99
  • Therapy / wait list group: current substance use disorder
  • Controls: no history of substance use disorders

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
  • Controls:
  • Drug intake modulating the central nervous system
  • Main psychiatric disorders
  • Current substance use
  • Inclusion Criteria:

Outcomes

Primary Outcomes

Aim 1: Sociodemographic background

Time Frame: T0

Sociodemographic background of adolescents with substance use disorders via self-constructed items: * age (in years) * gender (male/female) * highest education (primary school/ currently in high school/ dropped out of school/ finished compulsory school/ finished apprenticeship/ currently doing apprenticeship) * migration background (no/ yes \> asks for specification) * nationality (German/ other \> asks for specification) * relationship status (single/ married/ separated/ divorced/ widowed/ civil union/ domestic partnership/ other \> asks for specification)

Aim 2: Psychiatric comorbidities - MINI-KID

Time Frame: T0, T1, T2

Current psychiatric comorbidities according to Diagnostic and Statistic Manual of Mental Disorders, 5th Ed. (DSM-5) assessed via Mini International Neuropsychiatric Interview for Children and Adolescents (MINI KID), a structured diagnostic interview. Single interview questions rated (yes / no). DSM-5 diagnoses for past month (or other if specified) in accordance with MINI-KID scoring algorithms.

Aim 2: Change in substance use

Time Frame: T0, T1, T2

Changes in self-reported substance use between T0, T1, T2. Assessed via quantity and frequency questions for different substance categories.

Aim 3: Changes in biomarkers related to substance use disorders

Time Frame: T0, T1, T2

* cumulative stress: hair cortisol levels in a single hair sample. Measured in ng/ml. * epigenetic changes: methylation pattern in a single blood sample. Measured in %. * immunological changes: immune marker Interleukin-6 in a single blood sample. Measured in ng/ml.

Aim 4: Subjective therapy outcomes

Time Frame: T0, T1, T2

* Evaluation of possible therapy effects (e.g. knowledge, relapse prevention skills, emotions/affects, maintenance self-efficacy, motivation, stress tolerance) with 5-point Likert options (not at T0). * Substance use disorder severity assessed via Drug Use Disorders Identification Test (DUDIT). Measured in a test persons's scoring number on the DUDIT scale. Change from baseline DUDIT score to T1 and T2 DUDIT scores.

Aim 4: Objective therapy outcomes

Time Frame: between T0 and T1

- objective: Abstinence / relapse based on random drug urine tests for illicit substance use during therapy sessions.

Aim 5: Change in baseline parenting skills

Time Frame: T0, T1

Assessment of parenting skills (communication skills) via descriptive self-reports. Change from T0 to T1. Measured in self-reported description of change.

Aim 5: Change in baseline parental stress reports - ESF

Time Frame: T0, T1, T2

Change from self-reported baseline parent stress level to T1 anjd T2 parental stress levels. 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.

Secondary Outcomes

  • Emotional, behavioral and social problems of adolescents - Self-Rating (YSR)(Baseline data collection)
  • Emotional, behavioral and social problems of adolescents - Parental Rating (CBCL)(T0, T1, T2)
  • Adolescent depressivity - BDI-II(T0, T1, T2)
  • Mental distress - Brief Symptom Checklist(T0, T1, T2)
  • Adolescent satisfaction with life(T0, T1, T2)

Study Sites (1)

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