Deficit Hyperactivity Disorder / Substance Use Disorder Comorbidity in Integrated Treatment

NCT06858527 | Recruiting

• 2 other identifiers: APHP2404172023-A02246-39
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

Attention Deficit Hyperactivity Disorder (ADHD) and Substance Use Disorders (SUDs) is a highly common comorbid condition associated with serious medical and psychosocial consequences. However, and despite the international consensus recommending integrated treatment for this comorbidity, few studies tested the efficacy of specific psychotherapeutic treatment for this comorbidity. 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).

Conditions

Attention Deficit Hyperactivity Disorder (ADHD); Substance-related Disorder

Keywords

Attention Deficit Hyperactivity Disorder; Substance-Related Disorders; Cognitive Behavioral Therapy; Dual Diagnosis; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Emotion dysregulation

  Emotion dysregulation subscale of the Adult Self Report Scale for ADHD ( ASRS-31). The scale score ranges from 0 (low dysregulation) to 16 (high dysregulation).

  Week 1 ; Week 9 ; Week 18 ; Week 31

Secondary Outcomes (11)

• Substance use

  Week 1 ; Week 9 ; Week 18 ; Week 31

• Self-confidence in abstinence

  Week 1 ; Week 9 ; Week 18 ; Week 31

• Craving

  Week 1 ; Week 9 ; Week 18

• Nicotine dependence

  Week 1 ; Week 9 ; Week 18 ; Week 31

• ADHD symptoms

  Week 1 ; Week 9 ; Week 18

Study Arms (2)

Treatment-Waiting

OTHER

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.

Other: TAU+integrated group CBT

Waiting-Treatment

OTHER

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.

Other: TAU+integrated group CBT

Interventions

TAU+integrated group CBT OTHER

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.

Treatment-Waiting; Waiting-Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older ;
• 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

You may not qualify if:

• Age under 18;
• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Fernand Widal, Assistance-Publique - Hôpitaux de Paris

Paris, 75010, France

RECRUITING

Related Publications (20)

• 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.

  PMID: 25790353 BACKGROUND

• 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.

  PMID: 30769263 BACKGROUND

• 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.

  PMID: 22209385 BACKGROUND

• 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.

  PMID: 26260950 BACKGROUND

• 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.

  PMID: 33692893 BACKGROUND

• 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.

  PMID: 36674031 BACKGROUND

• 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.

  PMID: 32558914 BACKGROUND

• 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.

  PMID: 33666661 BACKGROUND

• 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.

  PMID: 32634814 BACKGROUND

• 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.

  PMID: 29566425 BACKGROUND

• 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.

  PMID: 33857730 BACKGROUND

• 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.

  PMID: 33526066 BACKGROUND

• 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.

  PMID: 32570249 BACKGROUND

• 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.

  PMID: 31849182 BACKGROUND

• 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.

  PMID: 27842945 BACKGROUND

• 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.

  PMID: 29510390 BACKGROUND

• 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.

  PMID: 30097390 BACKGROUND

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  PMID: 29137869 BACKGROUND

• Marlatt, G. A., & Donovan, D. M. (Éds.). (2005). Relapse prevention : Maintenance strategies in the treatment of addictive behaviors (2nd ed). Guilford Press.

  BACKGROUND

• Matthys, F., Bronckaerts, A., & Crunelle, C. L. (2018). Managing ADHD in the presence of substance use disorders. Gompel & Svacina

  BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Substance-Related Disorders

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Chemically-Induced Disorders

Study Officials

• Norman Therribout, PhD

  Paris-Nanterre University, UR-4430 CLIPSYD ; Paris-Cité University, UMR-S-1144 INSERM; Fernand-Widal Hospital AP-HP

  PRINCIPAL INVESTIGATOR

• Romain Icick, MD, PhD

  Paris-Cité University, UMR-S-1144 INSERM; Fernand-Widal Hospital AP-HP

  STUDY DIRECTOR

• Lucia Romo, MD, PhD

  Paris-Nanterre University, UR-4430 CLIPSYD

  STUDY DIRECTOR

Central Study Contacts

Norman Therribout, PhD

CONTACT

+33140054464; norman.therribout@aphp.fr

Romain Icick, MD, PhD

CONTACT

+33140054275; espace.murger.lrb@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All 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.

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 5, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2029
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)