Attention Deficit Hyperactivity Disorder (ADHD)ATTenTIFFNCT06858527
Deficit Hyperactivity Disorder / Substance Use Disorder Comorbidity in Integrated Treatment
A study testing TAU+integrated group CBT in people with Attention Deficit Hyperactivity Disorder (ADHD) and Substance-related Disorder, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Attention Deficit Hyperactivity Disorder (ADHD) and Substance Use Disorders (SUDs) is a highly common comorbid condition associated with serious medical and psychosocial consequences. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder (ADHD), Substance-related Disorder
- What is being tested?
- TAU+integrated group CBT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2025to Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Fernand Widal, Assistance-Publique - Hôpitaux de Paris
Paris, 75010
Norman Therribout, PhD, +330140054464, norman.therribout@aphp.fr
About this study
Official title: Adults With Attention Deficit Hyperactivity Disorder / Substance Use Disorder Comorbidity in Integrated Treatment: Effectiveness and Feasibility
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).
Read the detailed description
Substance Use Disorders (SUDs) affect between 0.5% and 15% of the general population and are responsible for a huge morbidity, mortality and social costs (Aldridge et al., 2018; Peterson et al., 2021). Among existing psychotherapeutic approaches, Cognitive and Behavioural Therapy (CBT) is one of the most widely validated, particularly in the addictive population (Hampel et al., 2020; Kabisa et al., 2021; Knapp et al., 2021; Marlatt \& Donovan, 2005; Ray et al., 2020). Psychiatric comorbidities are very often associated with SUD (Toftdahl et al., 2016). Among these, Attention Deficit Hyperactivity Disorder (ADHD) is one of the most common, occurring in more than 20% of adults with SUDs (Rohner et al., 2023; van Emmerik-van Oortmerssen et al., 2012) compared with 2.6% in the general population (Song et al., 2021).
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).
- Being tested
- TAU+integrated group CBT
- Keywords
- Attention Deficit Hyperactivity Disorder, Substance-Related Disorders, Cognitive Behavioral Therapy, Dual Diagnosis, Randomized Controlled Trial
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAU+integrated group CBTOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: TAU+integrated group CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Week 1 ; Week 9 ; Week 18 ; Week 31
Secondary outcomes (11)
Substance use
Description: Frequency and quantity of substance in the last 15 days, assessed with the Timeline Follow-Back Questionnaire (TLFB)
Measured: Week 1 ; Week 9 ; Week 18 ; Week 31
Self-confidence in abstinence
Description: Self-confidence in the capacity to not use substance in several tempting contexts, assessed with the Brief Situational Confidence Questionnaire (BSCQ). The scale score ranges from 0% (low self-confidence) to 16 (high self-confidence).
Measured: Week 1 ; Week 9 ; Week 18 ; Week 31
Craving
Craving frequency and intensity measured with the Craving Experience Questionnaire (CEQ).The frequency scale ranges from 11 (very infrequent) to 110 (always) and the intensity scale ranges from 11 (low) to 110 (extreme).
Measured: Week 1 ; Week 9 ; Week 18
Nicotine dependence
Nicotine dependence assessed with the Heaviness of Smoking Index (HSI).The total score ranges from 0 (no dependence) to 6 (severe dependence).
Measured: Week 1 ; Week 9 ; Week 18 ; Week 31
ADHD symptoms
ADHD symptoms are assessed with the total score of Adult Self Report Scale for ADHD (ASRS-32) and the four subscales (Inattention, Hyperactivity-Impulsivity, emotion dysregulation and executive functions deficit). ). The total score ranges from 0 (low ADHD severity) to 124 (high ADHD severity). The Inattention subscale ranges from 0 (low inattentive symptoms) to 36 (high inattentive symptoms). The Hyperactive-Impulsive subscale ranges from 0 (low hyperactive-impulsive symptoms) to 36 (high hyperactive-impulsive symptoms). The emotion dysregulation subscale ranges from 0 (low dysregulation) to 16 (high dysregulation). The executive function deficit subscale ranges from 0 (low deficit) to 36 (severe deficit).
Measured: Week 1 ; Week 9 ; Week 18
Impulsivity
Impulsivity is measured with the UPPS-P self-report scale. The UPPS-P total score ranges from 20 (low impulsivity) to 80 (high impulsivity).
Measured: Week 1 ; Week 9 ; Week 18
Perseverative thinking
Ruminations are assessed with the Perseverative Thinking Questionnaire (PTQ), a self-report scale. The total score ranges from 0 (no ruminations) to 40 (severe rumination).
Measured: Week 1 ; Week 9 ; Week 18
Global Quality of life
Global Quality of life is assessed with a visual analogue scale from 0 (very poor quality) to 100 (very good quality)
Measured: Week 1 ; Week 9 ; Week 18 ; Week 31
Physical Quality of life
Physical quality of life is assessed with a visual analogue scale from 0 (very poor quality) to 100 (very good quality)
Measured: Week 1 ; Week 9 ; Week 18 ; Week 31
Psychological Quality of life
Psychological quality of life is assessed with a visual analogue scale from 0 (very poor quality) to 100 (very good quality)
Measured: Week 1 ; Week 9 ; Week 18 ; Week 31
Self Esteem
Self-esteem is measured with a single self-report item : the Self Esteem Single Index (SISE)
Measured: Week 1 ; Week 9 ; Week 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start1 Apr 2025
- Primary completionJul 2029 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity Disorder (ADHD)Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Norman Therribout, PhD, Principal investigator, Paris-Nanterre University, UR-4430 CLIPSYD ; Paris-Cité University, UMR-S-1144 INSERM; Fernand-Widal Hospital AP-HPRomain Icick, MD, PhD, Study director, Paris-Cité University, UMR-S-1144 INSERM; Fernand-Widal Hospital AP-HPLucia Romo, MD, PhD, Study director, Paris-Nanterre University, UR-4430 CLIPSYD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06858527
- Sponsor's protocol ID
- APHP240417
- Other IDs
- 2023-A02246-39
- Acronym
- ATTenTIFF
- Status last verified
- Jun 2025
- First submitted
- 27 Feb 2025
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25790353van 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.
PubMed 30769263van 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.
PubMed 22209385Toftdahl 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.
PubMed 26260950Song 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.
PubMed 33692893Rohner 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.
PubMed 36674031Ray 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.
PubMed 32558914Peterson 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.
PubMed 33666661Ozgen 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.
PubMed 32634814Lopez 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.
PubMed 29566425Knapp 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.
PubMed 33857730Kabisa 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.
PubMed 33526066Icick 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.
PubMed 32570249Hampel 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.
PubMed 31849182Fatseas 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.
PubMed 27842945
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adults With Attention Deficit Hyperactivity Disorder / Substance Use Disorder Comorbidity in Integrated Treatment: Effectiveness and Feasibility
- ClinicalTrials.gov ID
- NCT06858527
- Acronym / sponsor ID
- ATTenTIFF / APHP240417
- Keywords
- Attention Deficit Hyperactivity Disorder, Substance-Related Disorders, Cognitive Behavioral Therapy, Dual Diagnosis, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 5 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Substance Use Disorders (SUDs) affect between 0.5% and 15% of the general population and are responsible for a huge morbidity, mortality and social costs (Aldridge et al., 2018; Peterson et al., 2021). Among existing psychotherapeutic approaches, Cognitive and Behavioural Therapy (CBT) is one of the most widely validated, particularly in the addictive population (Hampel et al., 2020; Kabisa et al., 2021; Knapp et al., 2021; Marlatt \& Donovan, 2005; Ray et al., 2020). Psychiatric comorbidities are very often associated with SUD (Toftdahl et al., 2016). Among these, Attention Deficit Hyperactivity Disorder (ADHD) is one of the most common, occurring in more than 20% of adults with SUDs (Rohner et al., 2023; van Emmerik-van Oortmerssen et al., 2012) compared with 2.6% in the general population (Song et al., 2021).
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment-Waiting | Other | Other: TAU+integrated group CBTFor 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. |
| Waiting-Treatment | Other | Other: TAU+integrated group CBTFor 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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 ;
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAU+integrated group CBTTAU+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. | Other | Treatment-Waiting, Waiting-Treatment |
Primary outcome
Emotion dysregulation
Time frame: Week 1 ; Week 9 ; Week 18 ; Week 31
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).
11 secondary outcomes
Substance use
Time frame: Week 1 ; Week 9 ; Week 18 ; Week 31
Self-confidence in abstinence
Time frame: Week 1 ; Week 9 ; Week 18 ; Week 31
Craving
Time frame: Week 1 ; Week 9 ; Week 18
Nicotine dependence
Time frame: Week 1 ; Week 9 ; Week 18 ; Week 31
ADHD symptoms
Time frame: Week 1 ; Week 9 ; Week 18
Impulsivity
Time frame: Week 1 ; Week 9 ; Week 18
Perseverative thinking
Time frame: Week 1 ; Week 9 ; Week 18
Global Quality of life
Time frame: Week 1 ; Week 9 ; Week 18 ; Week 31
Physical Quality of life
Time frame: Week 1 ; Week 9 ; Week 18 ; Week 31
Psychological Quality of life
Time frame: Week 1 ; Week 9 ; Week 18 ; Week 31
Self Esteem
Time frame: Week 1 ; Week 9 ; Week 18
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- Background: PubMed 25790353Young 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.
- Background: PubMed 30769263van 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.
- Background: PubMed 22209385van 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.
- Background: PubMed 26260950Toftdahl 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.
- Background: PubMed 33692893Song 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.
- Background: PubMed 36674031Rohner 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.
- Background: PubMed 32558914Ray 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.
- Background: PubMed 33666661Peterson 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.
- Background: PubMed 32634814Ozgen 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.
- Background: PubMed 29566425Lopez 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.
- Background: PubMed 33857730Knapp 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.
- Background: PubMed 33526066Kabisa 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Norman Therribout, PhD principal investigator
Paris-Nanterre University, UR-4430 CLIPSYD ; Paris-Cité University, UMR-S-1144 INSERM; Fernand-Widal Hospital AP-HP
Romain Icick, MD, PhD study director
Paris-Cité University, UMR-S-1144 INSERM; Fernand-Widal Hospital AP-HP
Lucia Romo, MD, PhD study director
Paris-Nanterre University, UR-4430 CLIPSYD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAU+integrated group CBT in people with Attention Deficit Hyperactivity Disorder (ADHD) and Substance-related Disorder, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Norman Therribout, PhD (+33140054464, norman.therribout@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emotion dysregulation (time frame: Week 1 ; Week 9 ; Week 18 ; Week 31). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06858527, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.