Attention Deficit Hyperactivity Disorder (ADHD) and opioid maintenance therapy.A randomized, placebo-controlled study of the efficacy of atomoxetine for treating adult ADHD in patients receiving opioid maintenance therapy

Conditions: MedDRA version: 12.1Level: LLTClassification code 10064104Term: ADHD
Patients will be recruited from out-patient clinics treating opioid dependent patients with buprenorphine or methadone maintenance therapy. Patients will be screened for ADHD symptoms. Based on the screen results, patients will undergo medical and psychiatric assessment to identify those meeting the criteria for adult ADHD. Patients diagnosed with comorbid ADHD and opioid dependence will then be randomized into atomoxetine and placebo study groups.

Registration Number: EUCTR2010-019981-94-FI

Lead Sponsor: HUS/ Neuropsykiatrian poliklinikka

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 30

Inclusion Criteria

Study inclusion requires patients to meet DSM-IV criteria for ADHD in childhood and adulthood as well as opioid dependence. Patients must have been committed to opioid maintenance therapy for at least six months prior to study entry.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion criteria are an unstable medical or psychiatric condition, pregnancy and nursing or a known sensitivity to atomoxetine.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To estimate the efficacy of atomoxetine when treating ADHD in patients with comorbid opioid dependence.;Secondary Objective: 1.To determine the impact of ADHD symptoms on the psychosocial functioning and quality of life in patients with comorbid ADHD and opioid dependence, by assessing possible differences between pharmacological treatment groups. <br>2.To determine the impact of ADHD on the outcome of opioid maintenance therapy, by assessing possible differences between pharmacological treatment groups. <br>;Primary end point(s): 7.1PRIMARY EFFICACY MEASURE<br>We will rate changes in ADHD symptomatology during pharmacotherapy using CAARS (Conners Adult ADHD Rating Scales; Conners et. al., 1999). An improvement in CAARS scores of 30 % or more is considered significant. <br>

Secondary Outcome Measures