Methylphenidate Treatment for Cocaine Abuse and ADHD - 1
2 other identifiers
interventional
124
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 1998
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 1998
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2004
CompletedFirst Submitted
Initial submission to the registry
August 25, 2005
CompletedFirst Posted
Study publicly available on registry
August 29, 2005
CompletedApril 23, 2019
April 1, 2019
5.9 years
August 25, 2005
April 22, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
1
EXPERIMENTALmethylphenidate
2
PLACEBO COMPARATORplacebo
Interventions
Eligibility Criteria
You may qualify if:
- Meets DSM-IV criteria for cocaine dependence
- Meets DSM-IV criteria for persistent adult Attention Deficit Hyperactive Disorder
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Research Foundation for Mental Hygiene, Inc.
New York, New York, 10032, United States
Related Publications (1)
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.
PMID: 16930863RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Frances R Levin, M.D.
Research Foundation for Mental Hygiene, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Substance Use Disorder
Study Record Dates
First Submitted
August 25, 2005
First Posted
August 29, 2005
Study Start
April 1, 1998
Primary Completion
March 1, 2004
Study Completion
March 1, 2004
Last Updated
April 23, 2019
Record last verified: 2019-04