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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01431235
Recruitment Status : Completed
First Posted : September 9, 2011
Last Update Posted : January 16, 2017
Fonds NutsOhra
Information provided by (Responsible Party):

Brief 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.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Substance Use Disorders Behavioral: cognitive behavioral therapy for treating ADHD symptoms Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 184 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : August 2011
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: standard addiction treatment
10 sessions of standard addiction treatment. No ADHD treatment.
Experimental: addiction treatment and ADHD treatment
10 sessions cognitive behavioral therapy on addiction treatment combined with 5 sessions on ADHD treatment.
Behavioral: cognitive behavioral therapy for treating ADHD symptoms
5 sessions of one hour CBT for treating ADHD symptoms by a trained health care worker

Primary Outcome Measures :
  1. self reported ADHD symptoms [ Time Frame: 6 months ]
    Dutch self report list of ADHD symptoms by Kooij and Buitelaar

Secondary Outcome Measures :
  1. Time Line Follow Back method [ Time Frame: 6 months ]
    self-reported alcohol and drug use

  2. Beck depression inventory [ Time Frame: 6 months ]
    self reported depression symptoms

  3. Beck Anxiety Inventory [ Time Frame: 6 months ]
    Self reported anxiety symptoms

  4. EQ-5 [ Time Frame: 6 months ]
    Self reported quality of living

  5. TIC-P [ Time Frame: 6 months ]
    health care consumption and production loss in relation to mental health problems

  6. Stroop task [ Time Frame: 6 months ]
    neuropsychological measure

  7. Tower of London task [ Time Frame: 6 months ]
    neuropsychological task

  8. BART task [ Time Frame: 6 months ]
    neuropsychological task on risk taking behavior

  9. urine checks [ Time Frame: 6 months ]
    urine checks on drug use

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01431235

Amsterdam, Netherlands
Sponsors and Collaborators
Fonds NutsOhra
Principal Investigator: Robert Schoevers, MD, PhD University Medical Center Groningen

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Arkin Identifier: NCT01431235     History of Changes
Other Study ID Numbers: 10-130
First Posted: September 9, 2011    Key Record Dates
Last Update Posted: January 16, 2017
Last Verified: January 2017

Keywords provided by Arkin:
cognitive behavioral therapy

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Substance-Related Disorders
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Chemically-Induced Disorders