ADHDPhase 3NCT00264797
Attention Deficit Hyperactivity Disorder (ADHD) in Adolescents With Substance Use Disorders (SUD)
A Phase 3 study testing Methylphenidate (OROS-MPH) in people with ADHD and Substance Abuse, run by University of Cincinnati at 12 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- ADHD, Substance Abuse
- What is being tested?
- Methylphenidate (OROS-MPH)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 303 participants
- Where
- 12 sitesUnited States
- Study dates
- Feb 2006to Oct 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Meet Diagnostic and Statistical Manual for Mental Disorders, 4th Edition (DSM-IV) diagnostic criteria for ADHD
- Meet DSM-IV diagnostic criteria for at least one non-nicotine substance use disorder
- Has a DSM-IV ADHD Symptom Checklist score ≥ 22 derived from the adolescent-completed checklist
Who cannot join
- Serious medical illness
- History of tic disorder
- Pregnant or breastfeeding
- Meet DSM-IV criteria for current or life-time psychotic disorder
- Meet DSM-IV criteria for current or life-time bipolar disorder
- Requires/or prescribed other concurrent psychotropic medication
Show all 11Show fewer
- Taking any medications that may produce interactions with OROS-MPH
- Opiate dependence
- Methamphetamine abuse or dependence
- Suicidal risk
- Enrolled in an inpatient, residential, day treatment, or outpatient substance abuse program within 28 days prior to signing consent
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Mountain Manor Treatment Programs
Baltimore, Maryland, 21229
LRADAC
Columbia, South Carolina, 29205
Synergy Treatment Center
Denver, Colorado, 80219
SSTAR: Stanley Street Treatment & Resources, Inc
Fall River, Massachusetts, 02720-6009
Mental Health and Retardation of Tarrant County
Fort Worth, Texas, 76107
Gateway Community Services
Jacksonville, Florida, 32211
Crittenton
Kansas City, Missouri, 64134
St. Luke's-Roosevelt Hospital, Child and Family Institute
New York, New York, 10025
SSTAR of Rhode Island
North Kingstown, Rhode Island, 02852
Rehab After Work-Life Counseling Services
Paoli, Pennsylvania, 19301
Addiction Medicine Services
Pittsburgh, Pennsylvania, 15213
Operation PAR, Inc.
St. Petersburg, Florida, 33709
About this study
Official title: Randomized Controlled Trial of Osmotic-Release Methylphenidate (OROS-MPH) for Attention Deficit Hyperactivity Disorder (ADHD) in Adolescents With Substance Use Disorders (SUD)
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.
Read the detailed description
Research shows a high prevalence of Attention Deficit Hyperactivity Disorder (ADHD) in adolescents with substance abuse disorders and indicates that they have poorer substance use treatment outcomes and poorer prognosis and risk of persistence and progression of drug use and behavior problems into adulthood. Although research indicates that the majority are not treated for ADHD while in substance treatment, we do not know whether concurrent pharmacotherapy for ADHD will improve treatment outcomes. This Clinical Trials Network (CTN) study will evaluate the efficacy of osmotic-release methylphenidate (OROS-MPH), relative to placebo, in treating ADHD and decreasing substance use in adolescents (13-18 years old) with ADHD and a substance use disorder. Approximately 300 participants will be recruited at 11 sites and randomly assigned to either OROS-MPH or matching placebo for a 16-week treatment period, during which all participants will receive individual cognitive-behavioral therapy as a standardized treatment for substance abuse.
- Conditions
- ADHD, Substance Abuse
- Being tested
- Methylphenidate (OROS-MPH), Methylphenidate (OROS-MPH) - Placebo
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylphenidate (OROS-MPH)Drug
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.
Methylphenidate (OROS-MPH) - PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Methylphenidate | Active comparator | Not described Receives: Drug: Methylphenidate (OROS-MPH) |
| Methylphenidate (Placebo) | Placebo comparator | Not described Receives: Drug: Methylphenidate (OROS-MPH) - Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 20 weeks
Secondary outcomes (2)
OROS-MPH Abuse Liability
Assessed by pill counts in conjunction with weekly review of subjects' medication diaries and self-reported medication compliance.
Measured: 20 weeks
Substance Use Outcomes
The mean number of negative urine drug screens (UDS).
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2005 (estimated)
- Study startFeb 2006
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), University of Colorado, Denver
- Responsible party
- Principal investigator, Theresa Winhusen, University of Cincinnati
- Investigators
- Paula Riggs, M.D., Principal investigator, University of Colorado, DenverTheresa Winhusen, Ph.D., Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00264797
- Sponsor's protocol ID
- NIDA-CTN-0028
- Other IDs
- 5U10DA013732
- Status last verified
- May 2013
- First submitted
- 10 Dec 2005
- Last updated
- 7 Jun 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 21871372Tamm 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.
PubMed 22889694
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Osmotic-Release Methylphenidate (OROS-MPH) for Attention Deficit Hyperactivity Disorder (ADHD) in Adolescents With Substance Use Disorders (SUD)
- ClinicalTrials.gov ID
- NCT00264797
- Acronym / sponsor ID
- NIDA-CTN-0028
- Conditions
- ADHD, Substance Abuse
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), University of Colorado, Denver
- Study start
- Feb 2006
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 13 Dec 2005 (estimated)
- Results
- Posted 7 Jun 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Research shows a high prevalence of Attention Deficit Hyperactivity Disorder (ADHD) in adolescents with substance abuse disorders and indicates that they have poorer substance use treatment outcomes and poorer prognosis and risk of persistence and progression of drug use and behavior problems into adulthood. Although research indicates that the majority are not treated for ADHD while in substance treatment, we do not know whether concurrent pharmacotherapy for ADHD will improve treatment outcomes. This Clinical Trials Network (CTN) study will evaluate the efficacy of osmotic-release methylphenidate (OROS-MPH), relative to placebo, in treating ADHD and decreasing substance use in adolescents (13-18 years old) with ADHD and a substance use disorder. Approximately 300 participants will be recruited at 11 sites and randomly assigned to either OROS-MPH or matching placebo for a 16-week treatment period, during which all participants will receive individual cognitive-behavioral therapy as a standardized treatment for substance abuse.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methylphenidate | Active comparator | Drug: Methylphenidate (OROS-MPH) |
| Methylphenidate (Placebo) | Placebo comparator | Drug: Methylphenidate (OROS-MPH) - Placebo |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Meet Diagnostic and Statistical Manual for Mental Disorders, 4th Edition (DSM-IV) diagnostic criteria for ADHD
- Meet DSM-IV diagnostic criteria for at least one non-nicotine substance use disorder
- Has a DSM-IV ADHD Symptom Checklist score ≥ 22 derived from the adolescent-completed checklist
Key exclusion criteria (11 listed)
- Serious medical illness
- History of tic disorder
- Pregnant or breastfeeding
- Meet DSM-IV criteria for current or life-time psychotic disorder
- Meet DSM-IV criteria for current or life-time bipolar disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methylphenidate (OROS-MPH)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. | Drug | Methylphenidate |
| Methylphenidate (OROS-MPH) - PlaceboParticipants 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. | Drug | Methylphenidate (Placebo) |
Primary outcome
ADHD Severity
Time frame: 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.
Substance Use
Time frame: 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.
2 secondary outcomes
OROS-MPH Abuse Liability
Time frame: 20 weeks
Substance Use Outcomes
Time frame: 20 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21871372Riggs 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.
- Derived from this study: PubMed 22889694Tamm 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paula Riggs, M.D. principal investigator
University of Colorado, Denver
Theresa Winhusen, Ph.D. principal investigator
University of Cincinnati
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Methylphenidate (OROS-MPH) in people with ADHD and Substance Abuse, run by University of Cincinnati at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jun 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ADHD Severity (time frame: baseline and 20 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00264797, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2013.