Deficit Hyperactivity Disorder / Substance Use Disorder Comorbidity in Integrated Treatment
NCT ID: NCT06858527
Last Updated: 2025-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
132 participants
INTERVENTIONAL
2025-04-01
2029-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The aim of this study is to test the efficacy of a specific group Cognitive and Behavioral Therapy (CBT) for the treatment of adults with this comorbidity.
This is a longitudinal, randomized controlled intervention study utilizing a crossover design between the intervention and treatment-as-usual (TAU) waitlist condition, aimed at testing the effectiveness of an integrated psychotherapeutic group treatment for adults with comorbid Attention Deficit Hyperactivity Disorder (ADHD) and Substance Use Disorders (SUDs).
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Feasibility and Efficacy of Cognitive-Behavioral Therapy for Patients With ADHD/Behavioral Addiction Comorbidity
NCT06797726
An Integrated Treatment for Comorbid PTSD and Substance Abuse in Adolescents
NCT01825694
Cognitive Behavioral Therapy for Treatment of Adult Attention Deficit Hyperactivity Disorder
NCT00118911
Serotonin Control of Impulsivity in Tourette Disorder
NCT05942716
Prevention of Comorbid Depression and Obesity in Attention-deficit/ Hyperactivity Disorder
NCT03371810
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The diagnosis and management of adult ADHD are difficult (Cortese et al., 2018; Lopez et al., 2018), particularly when ADHD is comorbid with SUD (Fatséas et al., 2016; Icick et al., 2020; Young et al., 2015). No specific treatment has been yet validated for this comorbidity. It is noteworthy that recognition of adult ADHD has grown considerably in France over the last years.
In this field, the international consensus on the screening, diagnosis and management of this comorbidity recommends integrated treatments (targeting the different disorders at the same time), combining pharmacotherapy with psychotherapy, emphasing the relevance of CBT in this field (Crunelle et al., 2018; Özgen et al., 2020). Despite these immense unmet needs, only one specific ADHD-SUDs psychotherapeutic program has been evaluated to date (van Emmerik-van Oortmerssen et al., 2019)
This protocol aims to test the efficacity of an integrated group Cognitive Behavioral Therapy (CBT) treatment for adults with comorbid Attention Deficit Hyperactivity Disorder (ADHD) and Substance Use Disorders (SUDs) on emotional dysregulation at the primary outcome. Addiction and ADHD symptoms, quality of life, self-esteem, and transdiagnostic constructs (impulsivity, perseverative thinking) are considered as secondary outcomes.
This study corresponds to a longitudinal intervention study using a cross-over design between the group intervention and treatment-as-usual (TAU) waiting condition.
Participants corresponding to inclusion criteria and consenting to participate are enrolled to the study and undergo a first interview assessing clinical and sociodemographic variables and self-rated questionnaires for primary and secondary outcomes. Then they are computer-randomised, controlling for duration of pharmacological treatment in two arms: (1) Treatment-Waiting and (2) Waiting-Treatment. In each condition (Waiting or Treatment) participant conserve their usual treatment for SUD and ADHD, excluding psychotherapeutic group interventions.
The first sequence consists in eight weeks of treatment (TAU for the Waiting-Intervention arm, and TAU+integrated group CBT for the Intervention-Waiting arm). The integrated group CBT consists in weekly two hours groups sessions. At the end of the first sequence and before the second sequence, participants undergo again self-report questionnaires for primary and secondary outcomes.
For the second sequence, participants switch the intervention condition for eight weeks (TAU+integrated group CBT for the Waiting-Intervention arm, and TAU for the Intervention-Waiting arm). At the end of this sequence, participants undergo again self-report questionnaires for primary and secondary outcomes, representing (1) post-intervention data for the Waiting-Intervention arm and (2) a two moths follow-up for the Intervention-Waiting arm.
The third sequence (follow-up) consists in three months of TAU condition, without any exclusion criteria for psychotherapeutic group interventions, ending with a last completion of a shortened battery of questionnaires for primary and secondary outcomes (if needed, questionnaires could be assessed by phone).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
The sessions will be punctuated by regular breaks to ensure participants' comfort and the integration of the skills worked on during the sessions.
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment-Waiting
For this arm, participants receive eight weekly sessions of CBT integrated group treatment in addition to TAU, and then eight weeks of TAU.
Then, 3 months follow-up, receiving TAU.
TAU+integrated group CBT
TAU+integrated group CBT : participants receive a group psychotherapeutic intervention of Integrated CBT lasting eight weekly two-hour sessions, in parallel with their usual individual care. The sessions are led by a psychologist trained and certified in the practice of CBT and a psychiatrist specialized in addiction medicine. The psychotherapeutic intervention follows a fixed structure and is inspired by the CBT manual for the management of ADHD associated with SUDs published by Matthys et al. (2018). This intervention includes modules on planning and organization, time and distraction management, emotional regulation, work on impulsive behaviors and social skills, cognitive work, as well as substance use management and relapse prevention.
The sessions will be punctuated by regular breaks to ensure participants' comfort and the integration of the skills worked on during the sessions.
TAU : participants receive their usual care, in exception of group psychotherapeutic interventions.
Waiting-Treatment
For this arm, participants receive eight weeks of TAU, and then eight weekly sessions of CBT integrated group treatment in addition to TAU Then, 3 months follow-up, receiving TAU.
TAU+integrated group CBT
TAU+integrated group CBT : participants receive a group psychotherapeutic intervention of Integrated CBT lasting eight weekly two-hour sessions, in parallel with their usual individual care. The sessions are led by a psychologist trained and certified in the practice of CBT and a psychiatrist specialized in addiction medicine. The psychotherapeutic intervention follows a fixed structure and is inspired by the CBT manual for the management of ADHD associated with SUDs published by Matthys et al. (2018). This intervention includes modules on planning and organization, time and distraction management, emotional regulation, work on impulsive behaviors and social skills, cognitive work, as well as substance use management and relapse prevention.
The sessions will be punctuated by regular breaks to ensure participants' comfort and the integration of the skills worked on during the sessions.
TAU : participants receive their usual care, in exception of group psychotherapeutic interventions.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
TAU+integrated group CBT
TAU+integrated group CBT : participants receive a group psychotherapeutic intervention of Integrated CBT lasting eight weekly two-hour sessions, in parallel with their usual individual care. The sessions are led by a psychologist trained and certified in the practice of CBT and a psychiatrist specialized in addiction medicine. The psychotherapeutic intervention follows a fixed structure and is inspired by the CBT manual for the management of ADHD associated with SUDs published by Matthys et al. (2018). This intervention includes modules on planning and organization, time and distraction management, emotional regulation, work on impulsive behaviors and social skills, cognitive work, as well as substance use management and relapse prevention.
The sessions will be punctuated by regular breaks to ensure participants' comfort and the integration of the skills worked on during the sessions.
TAU : participants receive their usual care, in exception of group psychotherapeutic interventions.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Suffer from at least one moderate to severe SUD regarding the DSM-5 (tobacco excluded) ;
* Being currently treated for a SUD by a physician of a psychologist ;
* Being diagnosed with an ADHD according to the DIVA 2.0 of DIVA-5 ;
* Being affiliated to a health insurance ;
* Understanding and being able to express himselves in French
* Signed consent
Exclusion Criteria
* Pregnant or breastfeeding women;
* Not having sign the consent form;
* Major difficulties in understanding and/or expressing themselves in french;
* Severe cognitive impairment;
* Acute medical condition making assessment impossible and/or contraindicating participation in group intervention;
* Substance use disorder in a protected environment, currentlu or in the last 15 days, or expected during the study;
* No substance use disorder other than tobacco use disorder;
* Persons under guardianship;
* Participant deprived of liberty or under penal care orders;
* Participation in another group psychotherapeutic intervention throughout the duration of the intervention
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Norman Therribout, PhD
Role: PRINCIPAL_INVESTIGATOR
Paris-Nanterre University, UR-4430 CLIPSYD ; Paris-Cité University, UMR-S-1144 INSERM; Fernand-Widal Hospital AP-HP
Romain Icick, MD, PhD
Role: STUDY_DIRECTOR
Paris-Cité University, UMR-S-1144 INSERM; Fernand-Widal Hospital AP-HP
Lucia Romo, MD, PhD
Role: STUDY_DIRECTOR
Paris-Nanterre University, UR-4430 CLIPSYD
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hôpital Fernand Widal, Assistance-Publique - Hôpitaux de Paris
Paris, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Young JT, Carruthers S, Kaye S, Allsop S, Gilsenan J, Degenhardt L, van de Glind G, van den Brink W, Preen D. Comorbid attention deficit hyperactivity disorder and substance use disorder complexity and chronicity in treatment-seeking adults. Drug Alcohol Rev. 2015 Nov;34(6):683-93. doi: 10.1111/dar.12249. Epub 2015 Mar 18.
van Emmerik-van Oortmerssen K, Vedel E, Kramer FJ, Blankers M, Dekker JJM, van den Brink W, Schoevers RA. Integrated cognitive behavioral therapy for ADHD in adult substance use disorder patients: Results of a randomized clinical trial. Drug Alcohol Depend. 2019 Apr 1;197:28-36. doi: 10.1016/j.drugalcdep.2018.12.023. Epub 2019 Feb 5.
van Emmerik-van Oortmerssen K, van de Glind G, van den Brink W, Smit F, Crunelle CL, Swets M, Schoevers RA. Prevalence of attention-deficit hyperactivity disorder in substance use disorder patients: a meta-analysis and meta-regression analysis. Drug Alcohol Depend. 2012 Apr 1;122(1-2):11-9. doi: 10.1016/j.drugalcdep.2011.12.007. Epub 2011 Dec 30.
Toftdahl NG, Nordentoft M, Hjorthoj C. Prevalence of substance use disorders in psychiatric patients: a nationwide Danish population-based study. Soc Psychiatry Psychiatr Epidemiol. 2016 Jan;51(1):129-40. doi: 10.1007/s00127-015-1104-4. Epub 2015 Aug 11.
Song P, Zha M, Yang Q, Zhang Y, Li X, Rudan I; Global Health Epidemiology Reference Group (GHERG). The prevalence of adult attention-deficit hyperactivity disorder: A global systematic review and meta-analysis. J Glob Health. 2021 Feb 11;11:04009. doi: 10.7189/jogh.11.04009.
Rohner H, Gaspar N, Philipsen A, Schulze M. Prevalence of Attention Deficit Hyperactivity Disorder (ADHD) among Substance Use Disorder (SUD) Populations: Meta-Analysis. Int J Environ Res Public Health. 2023 Jan 10;20(2):1275. doi: 10.3390/ijerph20021275.
Ray LA, Meredith LR, Kiluk BD, Walthers J, Carroll KM, Magill M. Combined Pharmacotherapy and Cognitive Behavioral Therapy for Adults With Alcohol or Substance Use Disorders: A Systematic Review and Meta-analysis. JAMA Netw Open. 2020 Jun 1;3(6):e208279. doi: 10.1001/jamanetworkopen.2020.8279.
Peterson C, Li M, Xu L, Mikosz CA, Luo F. Assessment of Annual Cost of Substance Use Disorder in US Hospitals. JAMA Netw Open. 2021 Mar 1;4(3):e210242. doi: 10.1001/jamanetworkopen.2021.0242.
Ozgen H, Spijkerman R, Noack M, Holtmann M, Schellekens ASA, van de Glind G, Banaschewski T, Barta C, Begeman A, Casas M, Crunelle CL, Daigre Blanco C, Dalsgaard S, Demetrovics Z, den Boer J, Dom G, Eapen V, Faraone SV, Franck J, Gonzalez RA, Grau-Lopez L, Groenman AP, Hemphala M, Icick R, Johnson B, Kaess M, Kapitany-Foveny M, Kasinathan JG, Kaye SS, Kiefer F, Konstenius M, Levin FR, Luderer M, Martinotti G, Matthys FIA, Meszaros G, Moggi F, Munasur-Naidoo AP, Post M, Rabinovitz S, Ramos-Quiroga JA, Sala R, Shafi A, Slobodin O, Staal WG, Thomasius R, Truter I, van Kernebeek MW, Velez-Pastrana MC, Vollstadt-Klein S, Vorspan F, Young JT, Yule A, van den Brink W, Hendriks V. International Consensus Statement for the Screening, Diagnosis, and Treatment of Adolescents with Concurrent Attention-Deficit/Hyperactivity Disorder and Substance Use Disorder. Eur Addict Res. 2020;26(4-5):223-232. doi: 10.1159/000508385. Epub 2020 Jul 7.
Lopez PL, Torrente FM, Ciapponi A, Lischinsky AG, Cetkovich-Bakmas M, Rojas JI, Romano M, Manes FF. Cognitive-behavioural interventions for attention deficit hyperactivity disorder (ADHD) in adults. Cochrane Database Syst Rev. 2018 Mar 23;3(3):CD010840. doi: 10.1002/14651858.CD010840.pub2.
Knapp KS, Brick TR, Bunce SC, Deneke E, Cleveland HH. Daily meaningfulness among patients with opioid use disorder: Examining the role of social experiences during residential treatment and links with post-treatment relapse. Addict Behav. 2021 Aug;119:106914. doi: 10.1016/j.addbeh.2021.106914. Epub 2021 Mar 16.
Kabisa E, Biracyaza E, Habagusenga JD, Umubyeyi A. Determinants and prevalence of relapse among patients with substance use disorders: case of Icyizere Psychotherapeutic Centre. Subst Abuse Treat Prev Policy. 2021 Feb 1;16(1):13. doi: 10.1186/s13011-021-00347-0.
Icick R, Moggi F, Slobodin O, Dom G, Mathys F, van den Brink W, Levin FR, Blankers M, Kaye S, Demetrovics Z, van de Glind G, Velez-Pastrana MC, Schellekens ASA; ICASA-group. Attention Deficit/Hyperactivity Disorder and Global Severity Profiles in Treatment-Seeking Patients with Substance Use Disorders. Eur Addict Res. 2020;26(4-5):201-210. doi: 10.1159/000508546. Epub 2020 Jun 22.
Hampel B, Kusejko K, Kouyos RD, Boni J, Flepp M, Stockle M, Conen A, Beguelin C, Kunzler-Heule P, Nicca D, Schmidt AJ, Nguyen H, Delaloye J, Rougemont M, Bernasconi E, Rauch A, Gunthard HF, Braun DL, Fehr J; Swiss HIV Cohort Study group. Chemsex drugs on the rise: a longitudinal analysis of the Swiss HIV Cohort Study from 2007 to 2017. HIV Med. 2020 Apr;21(4):228-239. doi: 10.1111/hiv.12821. Epub 2019 Dec 18.
Fatseas M, Hurmic H, Serre F, Debrabant R, Daulouede JP, Denis C, Auriacombe M. Addiction severity pattern associated with adult and childhood Attention Deficit Hyperactivity Disorder (ADHD) in patients with addictions. Psychiatry Res. 2016 Dec 30;246:656-662. doi: 10.1016/j.psychres.2016.10.071. Epub 2016 Nov 1.
Crunelle CL, van den Brink W, Moggi F, Konstenius M, Franck J, Levin FR, van de Glind G, Demetrovics Z, Coetzee C, Luderer M, Schellekens A; ICASA consensus group; Matthys F. International Consensus Statement on Screening, Diagnosis and Treatment of Substance Use Disorder Patients with Comorbid Attention Deficit/Hyperactivity Disorder. Eur Addict Res. 2018;24(1):43-51. doi: 10.1159/000487767. Epub 2018 Mar 6.
Cortese S, Adamo N, Del Giovane C, Mohr-Jensen C, Hayes AJ, Carucci S, Atkinson LZ, Tessari L, Banaschewski T, Coghill D, Hollis C, Simonoff E, Zuddas A, Barbui C, Purgato M, Steinhausen HC, Shokraneh F, Xia J, Cipriani A. Comparative efficacy and tolerability of medications for attention-deficit hyperactivity disorder in children, adolescents, and adults: a systematic review and network meta-analysis. Lancet Psychiatry. 2018 Sep;5(9):727-738. doi: 10.1016/S2215-0366(18)30269-4. Epub 2018 Aug 7.
Aldridge RW, Story A, Hwang SW, Nordentoft M, Luchenski SA, Hartwell G, Tweed EJ, Lewer D, Vittal Katikireddi S, Hayward AC. Morbidity and mortality in homeless individuals, prisoners, sex workers, and individuals with substance use disorders in high-income countries: a systematic review and meta-analysis. Lancet. 2018 Jan 20;391(10117):241-250. doi: 10.1016/S0140-6736(17)31869-X. Epub 2017 Nov 12.
Marlatt, G. A., & Donovan, D. M. (Éds.). (2005). Relapse prevention : Maintenance strategies in the treatment of addictive behaviors (2nd ed). Guilford Press.
Matthys, F., Bronckaerts, A., & Crunelle, C. L. (2018). Managing ADHD in the presence of substance use disorders. Gompel & Svacina
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2023-A02246-39
Identifier Type: OTHER
Identifier Source: secondary_id
APHP240417
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.