Trial · NCT00264797

Attention Deficit Hyperactivity Disorder (ADHD) in Adolescents With Substance Use Disorders (SUD)

NCT00264797, Phase 3, Completed, University of Cincinnati; results first posted 2013-06-07

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Attention Deficit Hyperactivity Disorder (ADHD) in Adolescents With Substance Use Disorders (SUD). Trials, record NCT00264797. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00264797

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Attention Deficit Hyperactivity Disorder (ADHD) in Adolescents With Substance Use Disorders (SUD)
NCT number: NCT00264797
Status: Completed
Phases: Phase 3
Enrollment: 303 participants, actual
Lead sponsor: University of Cincinnati
Conditions: ADHD, Substance Abuse
Interventions: Methylphenidate (OROS-MPH), Methylphenidate (OROS-MPH) - Placebo
First posted: 2005-12-13
Last updated: 2013-06-07
Results first posted: 2013-06-07

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	ADHD Severity	baseline and 20 weeks	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.
Primary	Substance Use	20 weeks	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.
Secondary	OROS-MPH Abuse Liability	20 weeks	Assessed by pill counts in conjunction with weekly review of subjects' medication diaries and self-reported medication compliance.
Secondary	Substance Use Outcomes	20 weeks	The mean number of negative urine drug screens (UDS).

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	ADHD Severity	baseline and 20 weeks	All randomized participants.	units on a scale	MEAN
PRIMARY	Substance Use	20 weeks	All randomized participants.	days	MEAN
SECONDARY	OROS-MPH Abuse Liability	20 weeks	All randomized participants.	pills	MEAN
SECONDARY	Substance Use Outcomes	20 weeks	All randomized participants.	negative UDS	MEAN

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
ADHD Severity	Methylphenidate	-20.6	Standard Deviation 11.1	units on a scale
ADHD Severity	Methylphenidate (Placebo)	-21.8	Standard Deviation 11.9	units on a scale
Substance Use	Methylphenidate	-5.7	95% Confidence Interval 0.8	days
Substance Use	Methylphenidate (Placebo)	-5.2	95% Confidence Interval 0.9	days
OROS-MPH Abuse Liability	Methylphenidate	15.4	Standard Deviation 18.7	pills
OROS-MPH Abuse Liability	Methylphenidate (Placebo)	9.7	Standard Deviation 11.2	pills
Substance Use Outcomes	Methylphenidate	3.8	Standard Deviation 4.9	negative UDS
Substance Use Outcomes	Methylphenidate (Placebo)	2.8	Standard Deviation 4.2	negative UDS

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Methylphenidate	151
Overall Study	STARTED	Methylphenidate (Placebo)	152
Overall Study	COMPLETED	Methylphenidate	118
Overall Study	COMPLETED	Methylphenidate (Placebo)	109
Overall Study	NOT COMPLETED	Methylphenidate	33
Overall Study	NOT COMPLETED	Methylphenidate (Placebo)	43

Source ClinicalTrials.gov

Adverse events66

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Headache	Nervous system disorders	Methylphenidate	70	151	141
other	Headache	Nervous system disorders	Methylphenidate (Placebo)	64	152	116
other	Nasopharyngitis	Infections and infestations	Methylphenidate	23	151	31
other	Nasopharyngitis	Infections and infestations	Methylphenidate (Placebo)	23	152	27
other	Viral Infection	Infections and infestations	Methylphenidate	18	151	27
other	Viral Infection	Infections and infestations	Methylphenidate (Placebo)	14	152	24
other	Upper Respiratory Tract Infection	Infections and infestations	Methylphenidate	12	151	13
other	Upper Respiratory Tract Infection	Infections and infestations	Methylphenidate (Placebo)	13	152	14
other	Influenza	Infections and infestations	Methylphenidate	5	151	6
other	Influenza	Infections and infestations	Methylphenidate (Placebo)	11	152	14

1 to 10 of 66Source ClinicalTrials.gov

See all 66 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Methylphenidate
Total, all-cause mortality	Methylphenidate (Placebo)
Total, other adverse events	Methylphenidate	70	151
Total, other adverse events	Methylphenidate (Placebo)	64	152
Total, serious adverse events	Methylphenidate	4	151
Total, serious adverse events	Methylphenidate (Placebo)	7	152

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
21871372	BACKGROUND	PubMed
22889694	DERIVED	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U10DA013732	Clinical Trials Network, Ohio Valley Node U10DA013732	WINHUSEN, T JOHN	UNIVERSITY OF CINCINNATI	NATIONAL INSTITUTE ON DRUG ABUSE	2000 to 2015

Source NIH RePORTER

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Methylphenidate vs Methylphenidate (Placebo): serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00264797

GET https://conductscience.org/api/trials/v1/NCT00264797/events?page=2

API reference For AI assistants