Clinical trial NCT03444974: Addiction in Adolescence - Pathomechanisms and Treatment Evaluation
Official title: Addiction and Substance Dependence in Adolescence - Neurobiological Pathomechanisms and Treatment Evaluation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Substance Use Disorders
Adolescent Behavior
Keywords: drugs
youth
adolescence
abuse
dependence
Tetrahydrocannabinol (THC)
Methamphetamine (Crystal Meth)
Marihuana
comorbidity
treatment
etiopathology
sociodemographics
Saxony
MATRIX
Psychotherapy
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2018-02-26
Enrollment: 450
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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 parental stress levels and parenting skills in the treatment group parents in comparison to waiting-list parents.
Primary purpose: TREATMENT

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.

Eligibility criteria: Adolescents:

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

Parents:

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 substance abuse

Primary outcomes:
measure: Aim 1: Sociodemographic background
timeFrame: T0
measure: Aim 2: Psychiatric comorbidities - MINI-KID
timeFrame: T0, T1, T2
measure: Aim 2: Change in substance use
timeFrame: T0, T1, T2
measure: Aim 3: Changes in biomarkers related to substance use disorders
timeFrame: T0, T1, T2
measure: Aim 4: Subjective therapy outcomes
timeFrame: T0, T1, T2
measure: Aim 4: Objective therapy outcomes
timeFrame: between T0 and T1
measure: Aim 5: Change in baseline parenting skills
timeFrame: T0, T1
measure: Aim 5: Change in baseline parental stress reports - ESF
timeFrame: T0, T1, T2
Secondary outcomes:
measure: Emotional, behavioral and social problems of adolescents - Self-Rating (YSR)
timeFrame: Baseline data collection
measure: Emotional, behavioral and social problems of adolescents - Parental Rating (CBCL)
timeFrame: T0, T1, T2
measure: Adolescent depressivity - BDI-II
timeFrame: T0, T1, T2
measure: Mental distress - Brief Symptom Checklist
timeFrame: T0, T1, T2
measure: Adolescent satisfaction with life
timeFrame: T0, T1, T2
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Department of Child and Adolescent Psychiatry and Psychotherapy, University Hospital C.G.Carus
state: Saxony
Study officials:
affiliation: Technische Universität Dresden, Universitätsklinikum C.G.C. Dresden
name: Veit Roessner, Prof. Dr.
role: STUDY_DIRECTOR
References:
citation: Zweben JE, Cohen JB, Christian D, Galloway GP, Salinardi M, Parent D, Iguchi M; Methamphetamine Treatment Project. Psychiatric symptoms in methamphetamine users. Am J Addict. 2004 Mar-Apr;13(2):181-90. doi: 10.1080/10550490490436055.
citation: Warden D, Sanchez K, Greer T, Carmody T, Walker R, Dela Cruz A, Toups M, Rethorst C, Trivedi MH. Demographic and clinical characteristics of current comorbid psychiatric disorders in a randomized clinical trial for adults with stimulant use disorders. Psychiatry Res. 2016 Dec 30;246:136-141. doi: 10.1016/j.psychres.2016.09.007. Epub 2016 Sep 15.
citation: Rawson RA, Marinelli-Casey P, Anglin MD, Dickow A, Frazier Y, Gallagher C, Galloway GP, Herrell J, Huber A, McCann MJ, Obert J, Pennell S, Reiber C, Vandersloot D, Zweben J; Methamphetamine Treatment Project Corporate Authors. A multi-site comparison of psychosocial approaches for the treatment of methamphetamine dependence. Addiction. 2004 Jun;99(6):708-17. doi: 10.1111/j.1360-0443.2004.00707.x.