Clinical trial NCT01431235: CBT for Patients With Attention Deficit Hyperactivity Disorder (ADHD) and Substance Use Disorders
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Substance Use Disorders
Keywords: ADHD
SUD
cognitive behavioral therapy
Lead sponsor: Arkin
Sponsor class: INDUSTRY
Collaborators: name: Fonds NutsOhra
First posted: 2011-09-09
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: self reported ADHD symptoms
timeFrame: 6 months
Secondary outcomes:
measure: Time Line Follow Back method
timeFrame: 6 months
measure: Beck depression inventory
timeFrame: 6 months
measure: Beck Anxiety Inventory
timeFrame: 6 months
measure: EQ-5
timeFrame: 6 months
measure: TIC-P
timeFrame: 6 months
measure: Stroop task
timeFrame: 6 months
measure: Tower of London task
timeFrame: 6 months
measure: BART task
timeFrame: 6 months
measure: urine checks
timeFrame: 6 months
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Arkin
Study officials:
affiliation: University Medical Center Groningen
name: Robert Schoevers, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.