Methylphenidate Treatment for Cocaine Abuse and ADHD - 1

New York State Psychiatric Institute

Status and phase

Completed

Phase 1

Conditions

Attention Deficit Disorder With Hyperactivity

Cocaine-Related Disorders

Treatments

Drug: Methylphenidate

Other: placebo

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00136734

#3236-NIDA-011755-1

R01DA011755 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

Many cocaine dependent individuals are also diagnosed with Attention Deficit Hyperactivity Disorder (ADHD). Methylphenidate (Ritalin) is currently approved to treat individuals diagnosed with ADHD. The purpose of this study is to determine the effectiveness of methylphenidate in treating ADHD symptoms in cocaine dependent individuals.

Full description

Methylphenidate (MPH) is commonly used to treat individuals diagnosed with ADHD. The purpose of this study is to determine the effectiveness of MPH in treating adult cocaine dependent individuals who are also diagnosed with ADHD.

Participants in this 14-week, double-blind, placebo-controlled study will be randomly assigned to receive either sustained-release MPH or placebo. All participants will receive individual cognitive behavioral therapy. The trial will last 14 weeks. It will include a 1-week placebo lead-in phase and a 2-week dose titration phase, followed by 11 weeks on a stable dose of MPH. During the titration phase, MPH will be given twice a day, starting at a dose of 10 mg/day. The dose will increase by 10 mg each day, until a final stable dose of 40 mg/day is reached. At this time, sustained-release MPH will be given as two 20 mg doses (one in the morning and one in the afternoon). Depending on a participant's tolerance of MPH, the dose will be increased to a maximum of 60 mg/day (40 mg in the morning and 20 mg in the afternoon). Participants who are unable to tolerate a dose of at least 40 mg/day of MPH will be discontinued from the study. Assessments of ADHD symptoms will be completed at weekly study visits. In addition, drug use assessments will also be completed and will include self-reports and urine toxicology tests.

Enrollment

124 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Meets DSM-IV criteria for cocaine dependence
Meets DSM-IV criteria for persistent adult Attention Deficit Hyperactive Disorder

Exclusion criteria

Meets DSM-IV criteria for current psychiatric disorders (other than ADHD or substance abuse) that requires a psychiatric intervention
Physiologically dependent on sedatives or alcohol, to the extent that medical attention is required during periods of abstinence or significant reduction in the amount of use
Exhibits suicidal or homicidal behavior within the two years prior to enrollment
Currently taking prescription psychotropic medication
Unstable medical condition (e.g., uncontrolled diabetes) that would make participation in the study hazardous
Known sensitivity to methylphenidate
Pregnant or breastfeeding