- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01431235
CBT for Patients With Attention Deficit Hyperactivity Disorder (ADHD) and Substance Use Disorders
January 13, 2017 updated by: Arkin
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.
Study Overview
Status
Completed
Intervention / Treatment
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
Enrollment (Actual)
184
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Amsterdam, Netherlands
- Arkin
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: standard addiction treatment
10 sessions of standard addiction treatment.
No ADHD treatment.
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Experimental: addiction treatment and ADHD treatment
10 sessions cognitive behavioral therapy on addiction treatment combined with 5 sessions on ADHD treatment.
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5 sessions of one hour CBT for treating ADHD symptoms by a trained health care worker
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
self reported ADHD symptoms
Time Frame: 6 months
|
Dutch self report list of ADHD symptoms by Kooij and Buitelaar
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time Line Follow Back method
Time Frame: 6 months
|
self-reported alcohol and drug use
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6 months
|
Beck depression inventory
Time Frame: 6 months
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self reported depression symptoms
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6 months
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Beck Anxiety Inventory
Time Frame: 6 months
|
Self reported anxiety symptoms
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6 months
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EQ-5
Time Frame: 6 months
|
Self reported quality of living
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6 months
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TIC-P
Time Frame: 6 months
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health care consumption and production loss in relation to mental health problems
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6 months
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Stroop task
Time Frame: 6 months
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neuropsychological measure
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6 months
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Tower of London task
Time Frame: 6 months
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neuropsychological task
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6 months
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BART task
Time Frame: 6 months
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neuropsychological task on risk taking behavior
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6 months
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urine checks
Time Frame: 6 months
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urine checks on drug use
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6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Robert Schoevers, MD, PhD, University Medical Center Groningen
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2011
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
December 1, 2016
Study Registration Dates
First Submitted
September 8, 2011
First Submitted That Met QC Criteria
September 8, 2011
First Posted (Estimate)
September 9, 2011
Study Record Updates
Last Update Posted (Estimate)
January 16, 2017
Last Update Submitted That Met QC Criteria
January 13, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Pathologic Processes
- Nervous System Diseases
- Neurologic Manifestations
- Dyskinesias
- Attention Deficit and Disruptive Behavior Disorders
- Neurodevelopmental Disorders
- Substance-Related Disorders
- Disease
- Attention Deficit Disorder with Hyperactivity
- Hyperkinesis
Other Study ID Numbers
- 10-130
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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