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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01431235
Other study ID # 10-130
Secondary ID
Status Completed
Phase N/A
First received September 8, 2011
Last updated January 13, 2017
Start date August 2011
Est. completion date December 2016

Study information

Verified date January 2017
Source Arkin
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 184
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
cognitive behavioral therapy for treating ADHD symptoms
5 sessions of one hour CBT for treating ADHD symptoms by a trained health care worker

Locations

Country Name City State
Netherlands Arkin Amsterdam

Sponsors (2)

Lead Sponsor Collaborator
Arkin Fonds NutsOhra

Country where clinical trial is conducted

Netherlands, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary self reported ADHD symptoms Dutch self report list of ADHD symptoms by Kooij and Buitelaar 6 months
Secondary Time Line Follow Back method self-reported alcohol and drug use 6 months
Secondary Beck depression inventory self reported depression symptoms 6 months
Secondary Beck Anxiety Inventory Self reported anxiety symptoms 6 months
Secondary EQ-5 Self reported quality of living 6 months
Secondary TIC-P health care consumption and production loss in relation to mental health problems 6 months
Secondary Stroop task neuropsychological measure 6 months
Secondary Tower of London task neuropsychological task 6 months
Secondary BART task neuropsychological task on risk taking behavior 6 months
Secondary urine checks urine checks on drug use 6 months
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