Addiction in Adolescence - Pathomechanisms and Treatment Evaluation

NCT ID: NCT03444974

Last Updated: 2019-04-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 450 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-01
• Study Completion Date: 2021-12-31

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.

Conditions

Substance Use Disorders; Adolescent Behavior

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patient therapy group

• Adolescents with substance use disorders
• Receiving an adapted treatment according to the MATRIX-A therapy

Group Type: ACTIVE_COMPARATOR

adapted treatment according to the MATRIX-A therapy

Intervention Type: OTHER

cognitive and behavioral treatment of drug abuse/dependency issues, as well as connected parameters

Parental therapy group

• Parents of adolescents with substance use disorders
• Receiving an adapted treatment according to the MATRIX-A therapy

Group Type: ACTIVE_COMPARATOR

adapted treatment according to the MATRIX-A therapy

Intervention Type: OTHER

cognitive and behavioral treatment of drug abuse/dependency issues, as well as connected parameters

Patient waiting list group

• Adolescents with substance use disorders
• On the waiting list for receiving a MATRIX-A therapy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Parental waiting list group

• Parents of adolescents with substance use disorders
• On the waiting list for receiving a MATRIX-A therapy

Group Type: NO_INTERVENTION

No interventions assigned to this group

control group

• Adolescents with no history of substance use disorders
• no other intake of psychotropic substances such as psychotropic medication

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

adapted treatment according to the MATRIX-A therapy

cognitive and behavioral treatment of drug abuse/dependency issues, as well as connected parameters

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

• 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

• 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:

• Current substance abuse

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Technische Universität Dresden

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Veit Roessner, Prof. Dr.

Role: STUDY_DIRECTOR

Technische Universität Dresden, Universitätsklinikum C.G.C. Dresden

Locations

Department of Child and Adolescent Psychiatry and Psychotherapy, University Hospital C.G.Carus

Dresden, Saxony, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Sören Kuitunen-Paul, Dipl.-Psych.

Role: CONTACT

soeren.kuitunen-paul@ukdd.de

+49 (0)351 458-7601

Yulia Golub, Dr.Dr.habil.

Role: CONTACT

yulia.golub@ukdd.de

+49 (0)351 458-7601

Facility Contacts

Sören Kuitunen-Paul, Dipl.-Psych.

Role: primary

soeren.kuitunen-paul@ukdd.de

+49 (0)351 458-7601

References

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.

Reference Type: BACKGROUND

PMID: 15204668 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27693866 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15139869 (View on PubMed)

Basedow LA, Kuitunen-Paul S, Wiedmann MF, Roessner V, Golub Y. Evaluation of the multimodal DELTA therapy for adolescents with substance use disorders: an exploratory pilot trial. Front Psychiatry. 2024 Jan 3;14:1284342. doi: 10.3389/fpsyt.2023.1284342. eCollection 2023.

Reference Type: DERIVED

PMID: 38234368 (View on PubMed)

Other Identifiers

MATRIX-A

Identifier Type: -

Identifier Source: org_study_id