Atomoxetine for Treating Cocaine Abuse in Adults With Attention Deficit Hyperactivity Disorder (ADHD)

NCT00218543 | Completed Phase 2 Results DMC

• 4 other identifiers: #4611P50DA009236P50-09236-12DPMC
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Attention Deficit Disorder With Hyperactivity; Cocaine-Related Disorders

Keywords

ADHD; Cocaine Abuse

Outcome Measures

Primary Outcomes (2)

• the Adult ADHD Rating Scale (AARS) (30% Reduction)

  AARS is a self report that measures symptoms of adult ADHD. The primary outcome was the percentage of patients achieving a 30% reduction from baseline on the AARS scale. The AARS is scored on a continuous, range 0-54. 0 being no symptoms and 54 being indicative of the most severe level of symptoms.

  baseline compared to rating at week 12 or last rating during study participation

• ADHD Symptoms Based on Adult ADHD Rating Scale Scale (AARS)

  Weekly AARS scores (continuous, range 0-54) were examined with the baseline score compared to that at the last assessment obtained and change in these scores over time. The AARS looks at adult ADHD symptoms. A score of 0 represents no symptoms and 54 would be indicative of the most severe level of symptoms.

  measured during 12 weeks or length of study participation

Study Arms (1)

Atomoxetine

EXPERIMENTAL

Atomoxetine

Drug: Atomoxetine

Interventions

Atomoxetine DRUG

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.

Atomoxetine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Meets DSM-IV criteria for cocaine dependence and adult ADHD
• Describes cocaine as the primary drug of abuse
• Meets DSM-IV criteria for cocaine dependence

You may not qualify if:

• Meets DSM-IV criteria for current Axis I psychiatric disorders that require a psychiatric intervention (except ADHD or substance abuse)
• Current major depression
• Unstable physical disorders that might make participation unsafe (e.g., uncontrolled high blood pressure and tachycardia \[systolic blood pressure greater than 150 mm Hg, diastolic blood pressure greater than 90 mm Hg, or a sitting heart rate greater than 100\])
• Acute hepatitis (individuals with chronic mildly elevated transaminase levels of less than 2 or 3 times the normal limit are not excluded)
• Diabetes
• Coronary vascular disease, as indicated by a history or suspected by an abnormal electrocardiogram
• History of cardiac symptoms
• History of seizures
• Narrow angle glaucoma
• Use of monoamine oxidase inhibitors (MAOIs) within 2 weeks of starting treatment with atomoxetine
• Currently taking prescribed psychotropic medications
• Currently taking medications for the treatment of ADHD
• Known sensitivity to atomoxetine
• Current suicidal ideation or history of suicidal or homicidal behavior within 2 years prior to study entry
• Pregnant or breastfeeding

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Research Foundation for Mental Hygiene, Inc.

New York, New York, 10032, United States

Location

Related Links

• Click here for the Substance Treatment and Research Service website

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Cocaine-Related Disorders

Interventions

Atomoxetine Hydrochloride

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals

Limitations and Caveats

Clearly, there are limitations of this study including the high drop-out rate, small sample size, and lack of a control group.

Results Point of Contact

• Title: Frances R Levin, MD
• Organization: COLUMBIA UNIVERSITY

FRL2@COLUMBIA.EDU

212-543-5896

Study Officials

• Herbert Kleber, MD

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Substance Use Disorder

Study Record Dates

• First Submitted: September 20, 2005
• First Posted: September 22, 2005
• Study Start: June 1, 2004
• Primary Completion: March 1, 2007
• Study Completion: March 1, 2007
• Last Updated: April 24, 2019
• Results First Posted: July 4, 2012

Record last verified: 2019-04

Locations

US (1)