CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
Atomoxetinedrug
Likely dose
Atomoxetine 80–100 mg/day orally (80 mg maintenance; increase to 100 mg if <50% symptom reduction)AI-extracted
Key inclusion· 3
  • Meets DSM-IV criteria for cocaine dependence
  • Meets DSM-IV criteria for adult ADHD
  • Cocaine is the primary drug of abuse
Key exclusion· 12
  • Current major depression or other Axis I psychiatric disorders requiring psychiatric intervention (except ADHD or substance abuse)
  • Unstable physical disorders including uncontrolled hypertension (SBP >150, DBP >90) or tachycardia (HR >100)
  • Acute hepatitis (chronic mild elevation <2–3× normal limit allowed)
  • Diabetes

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00218543
NCT00218543Phase 2Completed

Atomoxetine Treatment for Cocaine Abuse and Adult Attention-Deficit Hyperactivity Disorder (ADHD): A Preliminary Open Trial

New York State Psychiatric Institute·interventional·Posted Sep 22, 2005·Updated Apr 24, 2019

In Brief

A Phase 2 clinical trial evaluating Atomoxetine for Attention Deficit Disorder With Hyperactivity and Cocaine-Related Disorders. Completed, enrolled 20 participants across 1 site.

Detailed Summary

Studies have shown that individuals with attention deficit hyperactivity disorder (ADHD) are at greater risk for having a substance use disorder compared to people who do not have ADHD. Rates of cocaine abuse in adults with ADHD are significantly higher than they are in adults who do not have ADHD. Some clinicians suggest that adults with ADHD may abuse cocaine in order to self-medicate their ADHD symptoms. Atomoxetine is a drug that has been effective in treating ADHD. This study will evaluate the effectiveness of atomoxetine in reducing cocaine use in people with ADHD who abuse cocaine.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 22, 2005
Enrollment StartJun 1, 2004
Primary CompletionMar 1, 2007
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 20.8 years ago

Interventions

Atomoxetinedrug

At the start of week 7, patients will be maintained at 80 mg/day or increased to the maximal dose of 100 mg/day if less than a 50% reduction of symptoms on the ADHD Rating Scale occurs, and if the patient is tolerating the medication well.