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Methylphenidate Treatment for Cocaine Abuse and ADHD - 1

Primary Purpose

Attention Deficit Disorder With Hyperactivity, Cocaine-Related Disorders

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Methylphenidate
placebo
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Disorder With Hyperactivity focused on measuring ADHD, Cocaine dependence, treatment, methylphenidate

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Research Foundation for Mental Hygiene, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

methylphenidate

placebo

Outcomes

Primary Outcome Measures

ADHD symptom severity based on the ADHD rating scale score
self reported cocaine use

Secondary Outcome Measures

Full Information

First Posted
August 25, 2005
Last Updated
April 22, 2019
Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00136734
Brief Title
Methylphenidate Treatment for Cocaine Abuse and ADHD - 1
Official Title
Methylphenidate Treatment for Cocaine Abuse and ADHD
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
April 1998 (undefined)
Primary Completion Date
March 2004 (Actual)
Study Completion Date
March 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Disorder With Hyperactivity, Cocaine-Related Disorders
Keywords
ADHD, Cocaine dependence, treatment, methylphenidate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
124 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
methylphenidate
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
Methylphenidate
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
ADHD symptom severity based on the ADHD rating scale score
Time Frame
measured weekly for the 14 weeks of the trial or length of study participation
Title
self reported cocaine use
Time Frame
recorded daily for the 14 weeks of the trial or the length of participation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frances R Levin, M.D.
Organizational Affiliation
Research Foundation for Mental Hygiene, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Foundation for Mental Hygiene, Inc.
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16930863
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.
Results Reference
result
Links:
URL
http://stars.columbia.edu
Description
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Methylphenidate Treatment for Cocaine Abuse and ADHD - 1

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