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Attention Deficit Hyperactivity DisorderNCT01431235

CBT for Patients With Attention Deficit Hyperactivity Disorder (ADHD) and Substance Use Disorders

A study testing cognitive behavioral therapy for treating ADHD symptoms in people with Attention Deficit Hyperactivity Disorder and Substance Use Disorders, run by Arkin at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine if cognitive behavioral therapy is effective in treating ADHD symptoms in patients with substance use disorders and comorbid ADHD. Read more about this study

Who is it for?
Ages 18 to 60 years
What is being tested?
cognitive behavioral therapy for treating ADHD symptoms
Could I receive a placebo?
No, everyone receives an active treatment
How many people
184 participants
Where
1 siteNetherlands
Study dates
Aug 2011to Dec 2016
Phase
Interventional
Are there results?
None posted in the registry

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 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • substance use disorder
  • ADHD
  • able to comply with study activities

Who cannot join

  • severe neurological or psychiatric diseases (for example Parkinson, dementia, psychosis, bipolar depression) which require medication
  • unable to read or write Dutch language

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Arkin

    Amsterdam

Other trials in Netherlands

About this study

Official title: Investigating the Efficacy of Cognitive Behavioral Therapy in Patients With Substance Use Disorder and Comorbid ADHD. A Randomized Controlled Trial With Cognitive Behavioral Therapy

The purpose of this study is to determine if cognitive behavioral therapy is effective in treating ADHD symptoms in patients with substance use disorders and comorbid ADHD.

Read the detailed description

Attention Deficit Hyperactivity Disorder(ADHD) is an important comorbid condition in patients with substance use disorders (SUD). The prevalence of ADHD in patients with SUD is estimated 23%, and ADHD is associated with an untoward prognosis of SUD. However, adequate treatment programs for patients with ADHD and SUD are not available. Results of medication trials for patients with ADHD and SUD are disappointing, and cognitive behavioral therapy (CBT) has not yet been investigated in this population. In patients with ADHD without comorbid SUD, the results of CBT in randomized trials are positive. The purpose of this study is to investigate if CBT is effective in treating ADHD symptoms in patients with ADHD and SUD.

Being tested
cognitive behavioral therapy for treating ADHD symptoms
Keywords
ADHD, SUD, cognitive behavioral therapy
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.

  • cognitive behavioral therapy for treating ADHD symptomsBehavioural

    5 sessions of one hour CBT for treating ADHD symptoms by a trained health care worker

Study groups in NCT01431235
Study groupRoleWhat they receive
standard addiction treatmentNo intervention10 sessions of standard addiction treatment. No ADHD treatment.
addiction treatment and ADHD treatmentExperimental10 sessions cognitive behavioral therapy on addiction treatment combined with 5 sessions on ADHD treatment.
Receives: Behavioral: cognitive behavioral therapy for treating ADHD symptoms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. self reported ADHD symptoms

    Dutch self report list of ADHD symptoms by Kooij and Buitelaar

    Measured: 6 months

Secondary outcomes (9)

  1. Time Line Follow Back method

    self-reported alcohol and drug use

    Measured: 6 months

  2. Beck depression inventory

    self reported depression symptoms

    Measured: 6 months

  3. Beck Anxiety Inventory

    Self reported anxiety symptoms

    Measured: 6 months

  4. EQ-5

    Self reported quality of living

    Measured: 6 months

  5. TIC-P

    health care consumption and production loss in relation to mental health problems

    Measured: 6 months

  6. Stroop task

    neuropsychological measure

    Measured: 6 months

  7. Tower of London task

    neuropsychological task

    Measured: 6 months

  8. BART task

    neuropsychological task on risk taking behavior

    Measured: 6 months

  9. urine checks

    urine checks on drug use

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2011 (estimated)
  2. Study startAug 2011
  3. Primary completionDec 2016
  4. Study completionDec 2016

Resources

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
Parallel groups
Masking
None (open label)
Enrolment
184 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01431235
Sponsor's protocol ID
10-130
Status last verified
Jan 2017
First submitted
8 Sep 2011
Last updated
16 Jan 2017
Results posted
No
Data monitoring committee
No

Publications

  • Arias AJ, Gelernter J, Chan G, Weiss RD, Brady KT, Farrer L, Kranzler HR. Correlates of co-occurring ADHD in drug-dependent subjects: prevalence and features of substance dependence and psychiatric disorders. Addict Behav. 2008 Sep;33(9):1199-207. doi: 10.1016/j.addbeh.2008.05.003. Epub 2008 May 13.

    PubMed 18558465

  • Castells X, Ramos-Quiroga JA, Rigau D, Bosch R, Nogueira M, Vidal X, Casas M. Efficacy of methylphenidate for adults with attention-deficit hyperactivity disorder: a meta-regression analysis. CNS Drugs. 2011 Feb;25(2):157-69. doi: 10.2165/11539440-000000000-00000.

    PubMed 21254791

  • Safren SA, Sprich S, Mimiaga MJ, Surman C, Knouse L, Groves M, Otto MW. Cognitive behavioral therapy vs relaxation with educational support for medication-treated adults with ADHD and persistent symptoms: a randomized controlled trial. JAMA. 2010 Aug 25;304(8):875-80. doi: 10.1001/jama.2010.1192.

    PubMed 20736471

  • Solanto MV, Marks DJ, Wasserstein J, Mitchell K, Abikoff H, Alvir JM, Kofman MD. Efficacy of meta-cognitive therapy for adult ADHD. Am J Psychiatry. 2010 Aug;167(8):958-68. doi: 10.1176/appi.ajp.2009.09081123. Epub 2010 Mar 15.

    PubMed 20231319

  • van Emmerik-van Oortmerssen K, Vedel E, Koeter MW, de Bruijn K, Dekker JJ, van den Brink W, Schoevers RA. Investigating the efficacy of integrated cognitive behavioral therapy for adult treatment seeking substance use disorder patients with comorbid ADHD: study protocol of a randomized controlled trial. BMC Psychiatry. 2013 May 10;13:132. doi: 10.1186/1471-244X-13-132.

    PubMed 23663651

Questions about this trial

What is this clinical trial studying?

A study testing cognitive behavioral therapy for treating ADHD symptoms in people with Attention Deficit Hyperactivity Disorder and Substance Use Disorders, run by Arkin at 1 site in Netherlands.

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 3 inclusion and 2 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: finished, as of the sponsor's last update on 16 Jan 2017. 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 Netherlands. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

self reported ADHD symptoms (time frame: 6 months). 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 NCT01431235, which also lists 5 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 16 Jan 2017.

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