A Phase 3 interventional study of Methylphenidate (OROS-MPH) and Methylphenidate (OROS-MPH) - Placebo in ADHD and Substance Abuse, sponsored by University of Cincinnati. Completed at 12 sites in United States. Open to participants aged 13 Years to 18 Years. Per ClinicalTrials.gov, last updated 2013-06-07.
Sponsored by University of Cincinnati · Phase 3, Interventional, and Treatment
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.
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.
2,124 studies on the registry are indexed under Substance-Related Disorders; 393 are open to participants now.
This study's enrollment of 303 is above the median of 108 across 1,727 interventional studies indexed under Substance-Related Disorders.
Browse Substance-Related Disorders studies →University of Cincinnati is the lead sponsor of 314 studies on the registry; 43 are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 15 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Methylphenidate (OROS-MPH)
Drug: Methylphenidate (OROS-MPH) - Placebo
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.
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.
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.
Time frame: 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.
Time frame: 20 weeks
OROS-MPH Abuse Liability
Assessed by pill counts in conjunction with weekly review of subjects' medication diaries and self-reported medication compliance.
Time frame: 20 weeks
Substance Use Outcomes
The mean number of negative urine drug screens (UDS).
Time frame: 20 weeks
This trial was conducted by the National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) between March 2006 and October 2008. Eleven community based treatment programs recruited participants.
| Milestone | Methylphenidate | Methylphenidate (Placebo) |
|---|---|---|
| Started | 151 | 152 |
| Completed | 118 | 109 |
| Not completed | 33 | 43 |
| Withdrew: Withdrawal by subject | 11 | 11 |
| Withdrew: Lost to follow-up | 9 | 17 |
| Withdrew: Moved from area | 3 | 1 |
| Withdrew: Practical problems | 2 | 3 |
| Withdrew: Incarceration | 4 | 5 |
| Withdrew: Pressure/advice from outsiders | 1 | 1 |
| Withdrew: Feels treatment not necessary, not worki | 0 | 1 |
| Withdrew: Other | 3 | 4 |
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.
| units on a scale | Methylphenidate | Methylphenidate (Placebo) |
|---|---|---|
| ADHD Severity | -20.6 ± 11.1 | -21.8 ± 11.9 |
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.
| days | Methylphenidate | Methylphenidate (Placebo) |
|---|---|---|
| Substance Use | -5.7 ± 0.8 | -5.2 ± 0.9 |
Assessed by pill counts in conjunction with weekly review of subjects' medication diaries and self-reported medication compliance.
| pills | Methylphenidate | Methylphenidate (Placebo) |
|---|---|---|
| OROS-MPH Abuse Liability | 15.4 ± 18.7 | 9.7 ± 11.2 |
The mean number of negative urine drug screens (UDS).
| negative UDS | Methylphenidate | Methylphenidate (Placebo) |
|---|---|---|
| Substance Use Outcomes | 3.8 ± 4.9 | 2.8 ± 4.2 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Methylphenidate | — | 4/151 (2.6%) | 70/151 (46.4%) |
| Methylphenidate (Placebo) | — | 7/152 (4.6%) | 64/152 (42.1%) |
| Event | Methylphenidate | Methylphenidate (Placebo) |
|---|---|---|
| AggressionPsychiatric disorders | 1/151 | 2/152 |
| Psychotic DisorderPsychiatric disorders | 1/151 | 0/152 |
| Cyst RuptureGeneral disorders | 1/151 | 0/152 |
| Kidney InfectionInfections and infestations | 1/151 | 0/152 |
| SyncopeNervous system disorders | 0/151 | 1/152 |
| ConcussionInjury, poisoning and procedural complications | 0/151 | 1/152 |
| AsthmaRespiratory, thoracic and mediastinal disorders | 0/151 | 1/152 |
| Drug ToxicityInjury, poisoning and procedural complications | 0/151 | 1/152 |
| BronchitisInfections and infestations | 0/151 | 1/152 |
| Event | Methylphenidate | Methylphenidate (Placebo) |
|---|---|---|
| HeadacheNervous system disorders | 70/151 | 64/152 |
| Abdominal Pain UpperGastrointestinal disorders | 25/151 | 26/152 |
| Decreased AppetiteMetabolism and nutrition disorders | 25/151 | 9/152 |
| NasopharyngitisInfections and infestations | 23/151 | 23/152 |
| Pharyngolaryngeal PainRespiratory, thoracic and mediastinal disorders | 23/151 | 21/152 |
| InsomniaPsychiatric disorders | 21/151 | 18/152 |
| ContusionInjury, poisoning and procedural complications | 20/151 | 12/152 |
| CoughRespiratory, thoracic and mediastinal disorders | 16/151 | 19/152 |
| Viral InfectionInfections and infestations | 18/151 | 14/152 |
| VomitingGastrointestinal disorders | 16/151 | 14/152 |
| Age, Categorical(Participants) | Methylphenidate | Methylphenidate (Placebo) | Total |
|---|---|---|---|
| <=18 years | 151 | 152 | 303 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age Continuous(years) | Methylphenidate | Methylphenidate (Placebo) | Total |
|---|---|---|---|
| Mean | 16.4 ± 1.3 | 16.6 ± 1.2 | 16.5 ± 1.3 |
| Sex: Female, Male(Participants) | Methylphenidate | Methylphenidate (Placebo) | Total |
|---|---|---|---|
| Female | 29 | 35 | 64 |
| Male | 122 | 117 | 239 |
| Region of Enrollment(participants) | Methylphenidate | Methylphenidate (Placebo) | Total |
|---|---|---|---|
| United States | 151 | 152 | 303 |
This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.
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