Randomized Controlled Trial of Osmotic-Release Methylphenidate (OROS-MPH) for Attention Deficit Hyperactivity Disorder (ADHD) in Adolescents With Substance Use Disorders (SUD)
Sponsor study identifier
Secondary identifiers
NIH
interventional
303
1 country
12
Study Start
February 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2008
Actual (reported)Study Completion
October 2008
Actual (reported)The purpose of this study is to determine the efficacy of osmotic-release methylphenidate (OROS-MPH) versus placebo for the treatment of ADHD in adolescents with SUD.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2008
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 10, 2005
Actual (reported)December 13, 2005
Actual (reported)February 2006
Date type not reportedThis date has not been verified as actual or estimated.
October 2008
Actual (reported)October 2008
Actual (reported)June 7, 2013
Actual (reported)ADHD Severity
DSM IV ADHD Rating Scale (ADHD-RS) adolescent informant, ascertained at baseline and weekly throughout the 16 week study. This scale is an 18-item symptom checklist of self-reported adolescent ADHD symptoms. Symptoms are scored as None (0), Mild (1), Moderate (2), and Severe (3), with a summary total of scores for the 18 symptoms. Possible scores range from 0 to 54, with higher scores indicating greater severity. Outcome is measured as the decrease in total severity score over time.
baseline and 20 weeks
Substance Use
The change in number of days of substance use from baseline to end of the trial. The number of days of non-tobacco drug/alcohol ascertained using standard timeline follow back (TLFB) procedures.
20 weeks
OROS-MPH Abuse Liability
20 weeks
Substance Use Outcomes
20 weeks
Participants will be scheduled for weekly medication (OROS-MPH) and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Control intervention
Methylphenidate (OROS-MPH) - Placebo
The registry describes a control or simulated intervention. Active treatment exposure is not inferred.
View registry recordSynergy Treatment Center
Denver, Colorado, 80219, United States
Gateway Community Services
Jacksonville, Florida, 32211, United States
Operation PAR, Inc.
St. Petersburg, Florida, 33709, United States
Mountain Manor Treatment Programs
Baltimore, Maryland, 21229, United States
SSTAR: Stanley Street Treatment & Resources, Inc
Fall River, Massachusetts, 02720-6009, United States
Crittenton
Kansas City, Missouri, 64134, United States
St. Luke's-Roosevelt Hospital, Child and Family Institute
Riggs PD, Winhusen T, Davies RD, Leimberger JD, Mikulich-Gilbertson S, Klein C, Macdonald M, Lohman M, Bailey GL, Haynes L, Jaffee WB, Haminton N, Hodgkins C, Whitmore E, Trello-Rishel K, Tamm L, Acosta MC, Royer-Malvestuto C, Subramaniam G, Fishman M, Holmes BW, Kaye ME, Vargo MA, Woody GE, Nunes EV, Liu D. Randomized controlled trial of osmotic-release methylphenidate with cognitive-behavioral therapy in adolescents with attention-deficit/hyperactivity disorder and substance use disorders. J Am Acad Child Adolesc Psychiatry. 2011 Sep;50(9):903-14. doi: 10.1016/j.jaac.2011.06.010. Epub 2011 Aug 4.
Tamm L, Trello-Rishel K, Riggs P, Nakonezny PA, Acosta M, Bailey G, Winhusen T. Predictors of treatment response in adolescents with comorbid substance use disorder and attention-deficit/hyperactivity disorder. J Subst Abuse Treat. 2013 Feb;44(2):224-30. doi: 10.1016/j.jsat.2012.07.001. Epub 2012 Aug 11.
Paula Riggs, M.D.
University of Colorado, Denver
Theresa Winhusen, Ph.D.
University of Cincinnati
303 participants (actual enrollment reported by the registry).
First Submitted
December 10, 2005
First Posted
December 13, 2005
Study Start
February 2006
Date type not reportedThis date has not been verified as actual or estimated.
Participants will be scheduled for weekly medication and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH placebo for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
New York, New York, 10025, United States
Rehab After Work-Life Counseling Services
Paoli, Pennsylvania, 19301, United States
Addiction Medicine Services
Pittsburgh, Pennsylvania, 15213, United States
SSTAR of Rhode Island
North Kingstown, Rhode Island, 02852, United States
LRADAC
Columbia, South Carolina, 29205, United States
Mental Health and Retardation of Tarrant County
Fort Worth, Texas, 76107, United States
Primary Completion
October 2008
Actual (reported)Study Completion
October 2008
Actual (reported)Last Updated
June 7, 2013
Results First Posted
June 7, 2013
Record last verified: 2013-05
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Source: ClinicalTrials.gov.
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