Clinical trial NCT00136734: Methylphenidate Treatment for Cocaine Abuse and ADHD - 1
Official title: Methylphenidate Treatment for Cocaine Abuse and ADHD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Attention Deficit Disorder With Hyperactivity
Cocaine-Related Disorders
Keywords: ADHD
Cocaine dependence
treatment
methylphenidate
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2005-08-29
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: ADHD symptom severity based on the ADHD rating scale score
timeFrame: measured weekly for the 14 weeks of the trial or length of study participation
measure: self reported cocaine use
timeFrame: recorded daily for the 14 weeks of the trial or the length of participation
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Research Foundation for Mental Hygiene, Inc.
state: New York
Study officials:
affiliation: Research Foundation for Mental Hygiene, Inc.
name: Frances R Levin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Levin FR, Evans SM, Brooks DJ, Garawi F. Treatment of cocaine dependent treatment seekers with adult ADHD: double-blind comparison of methylphenidate and placebo. Drug Alcohol Depend. 2007 Feb 23;87(1):20-9. doi: 10.1016/j.drugalcdep.2006.07.004. Epub 2006 Aug 22.