Addiction in Adolescence - Pathomechanisms and Treatment Evaluation

Substance Use Disorders Clinical Trial

— MATRIX-A  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03444974
• Other study ID #: MATRIX-A
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2019
• Source: Technische Universität Dresden
• Contact: Sören Kuitunen-Paul, Dipl.-Psych.
• Phone: +49 (0)351 458-7601
• Email: soeren.kuitunen-paul[@]ukdd.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: December 31, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Behavior
• Substance Use Disorders
• Substance-Related Disorders

Intervention

Other:
• adapted treatment according to the MATRIX-A therapy
cognitive and behavioral treatment of drug abuse/dependency issues, as well as connected parameters

Locations

Country	Name	City	State
Germany	Department of Child and Adolescent Psychiatry and Psychotherapy, University Hospital C.G.Carus	Dresden	Saxony

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aim 1: Sociodemographic background	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)	T0
Primary	Aim 2: Psychiatric comorbidities - MINI-KID	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.	T0, T1, T2
Primary	Aim 2: Change in substance use	Changes in self-reported substance use between T0, T1, T2. Assessed via quantity and frequency questions for different substance categories.	T0, T1, T2
Primary	Aim 3: Changes in biomarkers related to substance use disorders	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.	T0, T1, T2
Primary	Aim 4: Subjective therapy outcomes	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.	T0, T1, T2
Primary	Aim 4: Objective therapy outcomes	- objective: Abstinence / relapse based on random drug urine tests for illicit substance use during therapy sessions.	between T0 and T1
Primary	Aim 5: Change in baseline parenting skills	Assessment of parenting skills (communication skills) via descriptive self-reports. Change from T0 to T1. Measured in self-reported description of change.	T0, T1
Primary	Aim 5: Change in baseline parental stress reports - ESF	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.	T0, T1, T2
Secondary	Emotional, behavioral and social problems of adolescents - Self-Rating (YSR)	Emotional, behavioral and social problems associated with adolescents with substance use disorders: 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.	Baseline data collection
Secondary	Emotional, behavioral and social problems of adolescents - Parental Rating (CBCL)	Emotional, behavioral and social problems associated with adolescents with substance use disorders: 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.	T0, T1, T2
Secondary	Adolescent depressivity - BDI-II	Psychiatric comorbidities associated with adolescents with substance use disorders: Data collection with help of the Beck Depression Inventory (BDI-II). Measured in a test persons's scoring number on the scale.	T0, T1, T2
Secondary	Mental distress - Brief Symptom Checklist	Psychiatric comorbidities associated with adolescents with substance use disorders: 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.	T0, T1, T2
Secondary	Adolescent satisfaction with life	Psychiatric comorbidities associated with adolescents with substance use disorders: 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).	T0, T1, T2

External Links

•   Department's main web site (German)