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. MedDRA version: 12.1 Level: LLT Classificatio
Conditions
Interventions
Trade Name: Strattera
Pharmaceutical Form: Capsule*
INN or Proposed INN: atomoxetinum
CAS Number: 82248-59-7
Other descriptive name: ATOMOXETINE HYDROCHLORIDE
Pharmaceutical form of the placebo: Capsu
Sponsors
HUS/ Neuropsykiatrian poliklinikka
Eligibility
Sex/Gender
All
Inclusion criteria
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: Exclusion criteria are an unstable medical or psychiatric condition, pregnancy and nursing or a known sensitivity to atomoxetine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. 2. To determine the impact of ADHD on the outcome of opioid maintenance therapy, by assessing possible differences between pharmacological treatment groups. ;Primary end point(s): 7.1 PRIMARY EFFICACY MEASURE 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. | — |
Countries
Finland
Outcome results
None listed