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Investigating Cognitive Behavioral Therapy in Patients With Attention Deficit Hyperactivity Disorder (ADHD) and Substance Use Disorders

This study is currently recruiting participants.
Verified September 2011 by Arkin
Sponsor:
Collaborator:
NutsOhra Funding
Information provided by (Responsible Party):
Arkin
ClinicalTrials.gov Identifier:
NCT01431235
First received: September 8, 2011
Last updated: NA
Last verified: September 2011
History: No changes posted
  Purpose

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 Intervention
Attention Deficit Hyperactivity Disorder
Substance Use Disorders
 Behavioral: cognitive behavioral therapy for treating ADHD symptoms

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Arkin:

Primary Outcome Measures:
  • self reported ADHD symptoms [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Dutch self report list of ADHD symptoms by Kooij and Buitelaar


Secondary Outcome Measures:
  • Time Line Follow Back method [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    self-reported alcohol and drug use

  • Beck depression inventory [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    self reported depression symptoms

  • Beck Anxiety Inventory [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Self reported anxiety symptoms

  • EQ-5 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Self reported quality of living

  • TIC-P [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    health care consumption and production loss in relation to mental health problems

  • Stroop task [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    neuropsychological measure

  • Tower of London task [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    neuropsychological task

  • BART task [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    neuropsychological task on risk taking behavior

  • urine checks [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    urine checks on drug use


Estimated Enrollment: 150
Study Start Date: August 2011
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01431235

Contacts
Contact: Katelijne van Emmerik - van Oortmerssen, MD +31205904423 katelijne.van.oortmerssen@arkin.nl

Locations
Netherlands
Arkin Recruiting
Amsterdam, Netherlands
Contact: Katelijne van Emmerik - van Oortmerssen, MD     +31205904423     katelijne.van.oortmerssen@arkin.nl    
Sponsors and Collaborators
Arkin
NutsOhra Funding
Investigators
Principal Investigator: Robert Schoevers, MD, PhD University Medical Centre Groningen
  More Information

Publications:

Responsible Party: Arkin
ClinicalTrials.gov Identifier: NCT01431235     History of Changes
Other Study ID Numbers: 10-130
Study First Received: September 8, 2011
Last Updated: September 8, 2011
Health Authority: The Netherlands: Central Committee on Research involving Human Subjects

Keywords provided by Arkin:
ADHD
SUD
cognitive behavioral therapy

Additional relevant MeSH terms:
Substance-Related Disorders
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Mental Disorders
Attention Deficit and Disruptive Behavior Disorders
 Mental Disorders Diagnosed in Childhood
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on June 13, 2013