Methylphenidate Treatment for Cocaine Abuse and ADHD - 1

Sponsor

New York State Psychiatric Institute (Other)

Overall Status

Completed

CT.gov ID

NCT00136734

Collaborator

National Institute on Drug Abuse (NIDA) (NIH)

124

Enrollment

Location

Arms

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Attention Deficit Disorder With Hyperactivity Cocaine-Related Disorders	Drug: Methylphenidate Other: placebo	Phase 1

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

124 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Methylphenidate Treatment for Cocaine Abuse and ADHD

Study Start Date :

Apr 1, 1998

Actual Primary Completion Date :

Mar 1, 2004

Actual Study Completion Date :

Mar 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 methylphenidate	Drug: Methylphenidate
Placebo Comparator: 2 placebo	Other: placebo placebo

Arm

Intervention/Treatment

Experimental: 1

methylphenidate

Drug: Methylphenidate

Placebo Comparator: 2

placebo

Other: placebo

placebo

Outcome Measures

Primary Outcome Measures

ADHD symptom severity based on the ADHD rating scale score [measured weekly for the 14 weeks of the trial or length of study participation]
self reported cocaine use [recorded daily for the 14 weeks of the trial or the length of participation]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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