Methylphenidate Treatment for Cocaine Abuse and ADHD - 1 | NCT00136734

Studies
Methylphenidate Treatment for Cocaine Abuse and ADHD - 1

NCT00136734

Sponsor

New York State Psychiatric Institute

Status

Completed

Last Update Posted

Apr 23, 2019Actual

Enrollment

124Actual

Phase

Phase 1

Conditions

Attention Deficit Disorder With Hyperactivity
Cocaine-Related Disorders

Interventions

Methylphenidate
placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R01DA011755	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1998

Primary Completion Date

Mar 2004Actual

Completion Date

Mar 2004Actual

First Submitted Date

Aug 25, 2005

First Submission Date that Met QC Criteria

Aug 25, 2005

First Posted Date

Aug 29, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 22, 2019

Last Update Posted Date

Apr 23, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Frances R Levin, Director of Substance Use Disorder, New York State Psychiatric InstitutePrincipal Investigator

Lead Sponsor

New York State Psychiatric InstituteOTHER

Collaborators

Name	Class
National Institute on Drug Abuse (NIDA)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

124Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	methylphenidate	Drug: Methylphenidate
2	Placebo Comparator	placebo	Other: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Methylphenidate	Drug		1
placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Frances R Levin, M.D.	Research Foundation for Mental Hygiene, Inc.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Foundation for Mental Hygiene, Inc.		New York	New York	10032	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16930863	Result	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.

ID	Term
D001289	Attention Deficit Disorder with Hyperactivity
D019970	Cocaine-Related Disorders

ID	Term
D019958	Attention Deficit and Disruptive Behavior Disorders
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders
D019966	Substance-Related Disorders

ID	Term
D010648	Phenylacetates
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals