Adult Attention Deficit Hyperactivity Disorder (ADHD)NCT00780208
Evaluating the Methylphenidate Patch to Treat Former Stimulant Users With ADHD
A study testing Daytrana (methylphenidate patch) in people with Adult Attention Deficit Hyperactivity Disorder (ADHD), run by Medical University of South Carolina at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness and safety of Daytrana® in the treatment of attention deficit hyperactivity disorder (ADHD) in adults who have abused stimulants in the past. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Adult Attention Deficit Hyperactivity Disorder (ADHD)
- What is being tested?
- Daytrana (methylphenidate patch)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Feb 2009
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy men and women, 18 to 65 years of age
- Meet DSM-IV criteria for past stimulant (cocaine, methamphetamine, or prescription stimulant) abuse or dependence, with past abuse/dependence defined as a minimum of three months since meeting DSM-IV criteria, or have exhibited a pattern of stimulant misuse. For the purposes of this study, stimulant misuse will be defined as using someone else's stimulant ADHD medication for a minimum of four times in a one-month period, and this misuse must have occurred for at least three months.
- Meet DSM-IV criteria for current ADHD, determined by a clinical interview and confirmed by semi-structured interview with the Conners' Adult ADHD Diagnostic Interview for DSM-IV (CAAR-D; Conners et al, 1999)
- ADHD symptom severity indicated by a score of 12 or greater on the Wender-Reimherr Adult Attention Deficit Disorder Scale
- All subjects will agree to and sign a written, IRB-approved informed consent
- Subjects must live within a 60-mile radius of Charleston, SC, to facilitate study visit compliance
Who cannot join
- Individuals meeting DSM-IV dependence for any substance with the exception of nicotine and caffeine
- Individuals meeting DSM-IV criteria for a lifetime history of schizophrenia or another non-affective psychotic disorder or bipolar disorder, since these patients will most likely be taking other psychotropic medications and often require intensive psychiatric care
- Individuals meeting DSM-IV criteria for current major depressive disorder or eating disorder, since these individuals will likely require treatment with psychotropic medications.
- Individuals who present significant suicidal risk
- Individuals with significant cognitive impairment as measured by a score of less than 26 on the Mini-Mental Status Exam, as they may be unable to understand the informed consent, comply with study protocol, or accurately complete assessments
- Individuals currently receiving stimulants, benzodiazepines, antidepressant or antipsychotic medications.
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- Individuals currently receiving psychotherapy focusing on reducing ADHD symptoms, as this could confound the effects of methylphenidate treatment
- Pregnant or nursing women, or women who refuse to use adequate birth control, as methylphenidate has not been approved for use in pregnancy
- Individuals without stable housing, as contacting these individuals would be difficult
- Individuals with major medical illnesses (e.g., HIV, renal failure, unstable angina, chronic obstructive pulmonary disease, infectious hepatitis)
- Patients with uncontrolled hypertension (defined as having blood pressure greater than 140/90 measured on 3 or more occasions), as methylphenidate treatment can be associated with increases in blood pressure
- Individuals with a significant family history of cardiac abnormalities, as these individuals may be more susceptible to cardiac adverse events
- Individuals who are obese (greater than 30% over ideal weight or BMI greater than 30) as this may interfere with absorption of methylphenidate
- Individuals who, in the investigators' opinion, would not be able to comply with study procedures, such as individuals unable to reliably present for intake appointments
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: The Evaluation of the Safety and Efficacy of the Methylphenidate Patch in Former Stimulant Users With ADHD
The purpose of this study is to evaluate the effectiveness and safety of Daytrana® in the treatment of attention deficit hyperactivity disorder (ADHD) in adults who have abused stimulants in the past. Daytrana® is a stimulant medication that has been approved by the Food and Drug Administration for the treatment of ADHD in children over the age of 6 years old.
Read the detailed description
Methylphenidate and amphetamines are considered to be the first line of treatment for ADHD in children (Biederman et al, 1997). Although treating children and adolescents with stimulants does not appear to increase the risk of substance use disorders (Wilens et al, 2003), little is known about the abuse of prescription stimulants in adults with ADHD. A review of the literature on the abuse potential of methylphenidate in animals and humans found that methylphenidate produced reinforcing, discriminative-stimulus, and subjective effects similar to amphetamines or cocaine (Kollins et al, 2001). Although the abuse rates of methylphenidate and other stimulant medications used for the treatment of ADHD have not been empirically established, significant concern exists so that regulatory mandates are enforced to control distribution, and some physicians may be reluctant to use stimulants in patients with drug abuse histories. The introduction of a methylphenidate patch is an important advancement, as the patch formulation should increase compliance while minimizing abuse potential, making it an attractive treatment option in the large population of individuals who have a history of previous drug misuse. The primary aim of this study is to assess the efficacy of the methylphenidate patch in adult individuals with ADHD who have abused stimulants in the past. It is hypothesized that the methylphenidate patch will be efficacious in reducing ADHD symptoms in this population.
- Being tested
- Daytrana (methylphenidate patch)
- Keywords
- Attention Deficit Hyperactivity ADHD
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daytrana (methylphenidate patch)Drug
Also called Daytrana Patch, Methylphenidate Patch
Subjects will be provided with a 7-day supply of medication at each study visit. The dose will be flexible and will be titrated based on effect and tolerability. Unless a subject is experiencing side effects, the dose will be increased if a 25% reduction in ADHD symptoms as determined by the WRAADDS is not obtained. A proposed dosing schedule is as follows: Week 1: 12.5 cm2, Week 2: 18.75 cm2, Week 3: 25 cm2, Week 4: 37.5 cm2. The dose may be decreased as needed for tolerability.
| Study group | Role | What they receive |
|---|---|---|
| Daytrana (methylphenidate patch) | Other | Methylphenidate patch Receives: Drug: Daytrana (methylphenidate patch) |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADHD Symptom Severity
Primary efficacy endpoint will be ADHD symptom severity, as measured by mean change from baseline in the Wender-Reimherr Adult Attention Deficit Disorder Scale total score (WRAADS).The WRAADS measures symptoms in 7 categories: attention difficulties, hyperactivity/restlessness, temper, affective lability, emotional overreactivity, disorganization, and impulsivity. The scale rates individual items from 0 to 2 (0 = not present, 1 = mild, 2 = clearly present) so there may be a minimum total score of 0 (no symptoms present) through a maximum score of 56 (symptoms clearly present).
Measured: Baseline, Week 8
Secondary outcomes (1)
Number of Participants With Positive Drug Screen
Secondary efficacy endpoints will be substance use during the study, as measured by total number of participants testing positive for substances other than a stimulant on weekly urine drug screens
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2008 (estimated)
- Study startApr 2007
- Primary completionOct 2008
- Study completionFeb 2009
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.
- Other trials for Adult Attention Deficit Hyperactivity Disorder (ADHD)Studies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Shire
- Responsible party
- Principal investigator, Aimee McRae-Clark, Medical University of South Carolina
- Investigators
- Aimee L. McRae-Clark, Pharm.D., Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00780208
- Sponsor's protocol ID
- HR#16784
- Status last verified
- Jun 2018
- First submitted
- 23 Oct 2008
- Last updated
- 14 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of the Safety and Efficacy of the Methylphenidate Patch in Former Stimulant Users With ADHD
- ClinicalTrials.gov ID
- NCT00780208
- Acronym / sponsor ID
- HR#16784
- Keywords
- Attention Deficit Hyperactivity ADHD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Shire
- Study start
- Apr 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 27 Oct 2008 (estimated)
- Results
- Posted 14 Jun 2018
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 evaluate the effectiveness and safety of Daytrana® in the treatment of attention deficit hyperactivity disorder (ADHD) in adults who have abused stimulants in the past. Daytrana® is a stimulant medication that has been approved by the Food and Drug Administration for the treatment of ADHD in children over the age of 6 years old.
Detailed description
Methylphenidate and amphetamines are considered to be the first line of treatment for ADHD in children (Biederman et al, 1997). Although treating children and adolescents with stimulants does not appear to increase the risk of substance use disorders (Wilens et al, 2003), little is known about the abuse of prescription stimulants in adults with ADHD. A review of the literature on the abuse potential of methylphenidate in animals and humans found that methylphenidate produced reinforcing, discriminative-stimulus, and subjective effects similar to amphetamines or cocaine (Kollins et al, 2001). Although the abuse rates of methylphenidate and other stimulant medications used for the treatment of ADHD have not been empirically established, significant concern exists so that regulatory mandates are enforced to control distribution, and some physicians may be reluctant to use stimulants in patients with drug abuse histories. The introduction of a methylphenidate patch is an important advancement, as the patch formulation should increase compliance while minimizing abuse potential, making it an attractive treatment option in the large population of individuals who have a history of previous drug misuse. The primary aim of this study is to assess the efficacy of the methylphenidate patch in adult individuals with ADHD who have abused stimulants in the past. It is hypothesized that the methylphenidate patch will be efficacious in reducing ADHD symptoms in this population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Daytrana (methylphenidate patch) | Other | Drug: Daytrana (methylphenidate patch)Methylphenidate patch |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy men and women, 18 to 65 years of age
- Meet DSM-IV criteria for past stimulant (cocaine, methamphetamine, or prescription stimulant) abuse or dependence, with past abuse/dependence defined as a minimum of three months since meeting DSM-IV criteria, or have exhibited a pattern of stimulant misuse. For the purposes of this study, stimulant misuse will be defined as using someone else's stimulant ADHD medication for a minimum of four times in a one-month period, and this misuse must have occurred for at least three months.
- Meet DSM-IV criteria for current ADHD, determined by a clinical interview and confirmed by semi-structured interview with the Conners' Adult ADHD Diagnostic Interview for DSM-IV (CAAR-D; Conners et al, 1999)
- ADHD symptom severity indicated by a score of 12 or greater on the Wender-Reimherr Adult Attention Deficit Disorder Scale
- All subjects will agree to and sign a written, IRB-approved informed consent
Key exclusion criteria (14 listed)
- Individuals meeting DSM-IV dependence for any substance with the exception of nicotine and caffeine
- Individuals meeting DSM-IV criteria for a lifetime history of schizophrenia or another non-affective psychotic disorder or bipolar disorder, since these patients will most likely be taking other psychotropic medications and often require intensive psychiatric care
- Individuals meeting DSM-IV criteria for current major depressive disorder or eating disorder, since these individuals will likely require treatment with psychotropic medications.
- Individuals who present significant suicidal risk
- Individuals with significant cognitive impairment as measured by a score of less than 26 on the Mini-Mental Status Exam, as they may be unable to understand the informed consent, comply with study protocol, or accurately complete assessments
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 |
|---|---|---|
| Daytrana (methylphenidate patch)Also: Daytrana Patch, Methylphenidate PatchSubjects will be provided with a 7-day supply of medication at each study visit. The dose will be flexible and will be titrated based on effect and tolerability. Unless a subject is experiencing side effects, the dose will be increased if a 25% reduction in ADHD symptoms as determined by the WRAADDS is not obtained. A proposed dosing schedule is as follows: Week 1: 12.5 cm2, Week 2: 18.75 cm2, Week 3: 25 cm2, Week 4: 37.5 cm2. The dose may be decreased as needed for tolerability. | Drug | Daytrana (methylphenidate patch) |
Primary outcome
ADHD Symptom Severity
Time frame: Baseline, Week 8
Primary efficacy endpoint will be ADHD symptom severity, as measured by mean change from baseline in the Wender-Reimherr Adult Attention Deficit Disorder Scale total score (WRAADS).The WRAADS measures symptoms in 7 categories: attention difficulties, hyperactivity/restlessness, temper, affective lability, emotional overreactivity, disorganization, and impulsivity. The scale rates individual items from 0 to 2 (0 = not present, 1 = mild, 2 = clearly present) so there may be a minimum total score of 0 (no symptoms present) through a maximum score of 56 (symptoms clearly present).
1 secondary outcome
Number of Participants With Positive Drug Screen
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Aimee L. McRae-Clark, Pharm.D. principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daytrana (methylphenidate patch) in people with Adult Attention Deficit Hyperactivity Disorder (ADHD), run by Medical University of South Carolina at 1 site 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 6 inclusion and 14 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 14 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jun 2018). 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 Symptom Severity (time frame: Baseline, Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jun 2018.