ADHDPhase 2/3NCT00061087
Treatment of Adult Attention Deficit Hyperactivity Disorder (ADHD) in Methadone Patients - 1
A Phase 2/3 study testing Methylphenidate and Bupropion in people with ADHD and Opioid-Related Disorders, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
The purpose of this study is to treat Adult Attention Deficit Hyperactivity Disorder (ADHD) in methadone patients. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- ADHD, Opioid-Related Disorders, Cocaine Dependence
- What is being tested?
- Methylphenidate and Bupropion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 1998to Oct 2004
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Individuals who meet DSM-IV criteria for opiate dependence and are currently maintained on methadone
- Patients must meet DSM-IV criteria for persistent adult ADHD
- Must be on stable methadone dose for at least 3 weeks
- Individuals positive for HIV will not be excluded.
Who cannot join
- Patients meeting DSM-IV criteria for current psychiatric disorders (other than ADHD or substance abuse) which requires psychiatric intervention
- Patients who are physiologically dependent on either sedatives or alcohol such that they experience symptoms requiring medical attention during periods of abstinence or significant reduction in amount of use
- Individuals diagnosed with other forms of adult ADHD other than persistent, particularly substance-induced ADHD
- Those who have an unstable medical condition which might make participation hazardous, including but not restricted to: uncontrolled hypertension, (SBP >160, DBP>100, PULSE >110), uncontrolled liver disease, uncontrolled diabetes, acute hepatitis, uncontrolled heart disease as indicated by history or abnormal ECG, glaucoma, or history of urinary retention or seizures, or advanced AIDS will not be included
- Patients who are taking prescription psychotropic medications other than methadone
- Patients who have exhibited suicidal or homicidal behavior within the past two years
Show all 12Show fewer
- Patients with known sensitivity to MPH or BPR
- Patients with cognitive impairment or who cannot read or understand the self-report assessment forms unaided or are so severely disabled they cannot comply with the requirements of the study.
- Patients unable to give full and informed consent
- Patients with a history of an eating disorder
- Patients recently convicted of a violent crime. (last two years)
- Nursing mothers and pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
Research Foundation for Mental Hygiene, Inc.
New York, New York, 10032
About this study
Official title: Treatment of Adult ADHD in Methadone Patients
The purpose of this study is to treat Adult Attention Deficit Hyperactivity Disorder (ADHD) in methadone patients.
Read the detailed description
This project is a three armed double-blind, placebo-controlled, randomized trial comparing the efficacy of MPH and BPR, relative to each other and to placebo, for treating persistent ADHD in methadone-maintained patients. One hundred and twenty subjects, will be randomized to receive either MPH, BPR, or placebo with equal probability. Randomization will be stratified by site, and whether or not cocaine is also being used. Efficacy will be measured by treatment retention, reduction in illicit drug use and drug craving, improvement of ADHD symptoms and overall functional status.
- Conditions
- ADHD, Opioid-Related Disorders, Cocaine Dependence
- Being tested
- Methylphenidate, Bupropion, Placebo
- Keywords
- ADHD, Cocaine, Treatment, Methadone
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Opioid-Related Disorders, Cocaine-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethylphenidateDrug
Methylphenidate 80mg/day
BupropionDrug
Bupropion 400mg/day
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| METHYLPHENIDATE | Active comparator | Methylphenidate Receives: Drug: Methylphenidate |
| BUPROPION | Active comparator | Bupropion Receives: Drug: Bupropion |
| PLACEBO | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cocaine use based on urine toxicology
Measured: collected 3 times per week for 12 weeks of the trial or length of study participation
ADHD symptom severity based on the ADHD Rating scale score
Measured: measured once per week for 12 weeks or length of study participation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2003 (estimated)
- Study startFeb 1998
- Primary completionOct 2004
- Study completionOct 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ADHDStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Frances R Levin, New York State Psychiatric Institute
- Investigators
- Frances R Levin, M.D., Principal investigator, Research Foundation for Mental Hygiene, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00061087
- Sponsor's protocol ID
- NIDA-011444-1,#4184R
- Other IDs
- R01DA011444, 4184R
- Status last verified
- Apr 2019
- First submitted
- 21 May 2003
- Last updated
- 23 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Brooks DJ, Vosburg SK, Evans SM, Levin FR. Assessment of cognitive functioning of methadone-maintenance patients: impact of adult ADHD and current cocaine dependence. J Addict Dis. 2006;25(4):15-25. doi: 10.1300/J069v25n04_02.
PubMed 17088222Levin FR, Evans SM, Brooks DJ, Kalbag AS, Garawi F, Nunes EV. Treatment of methadone-maintained patients with adult ADHD: double-blind comparison of methylphenidate, bupropion and placebo. Drug Alcohol Depend. 2006 Feb 1;81(2):137-48. doi: 10.1016/j.drugalcdep.2005.06.012. Epub 2005 Aug 15.
PubMed 16102908
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Adult ADHD in Methadone Patients
- ClinicalTrials.gov ID
- NCT00061087
- Acronym / sponsor ID
- NIDA-011444-1,#4184R
- Conditions
- ADHD, Opioid-Related Disorders, Cocaine Dependence
- Keywords
- ADHD, Cocaine, Treatment, Methadone
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Feb 1998
- Primary completion
- Oct 2004 (actual)
- Study completion
- Oct 2004 (actual)
- First posted
- 22 May 2003 (estimated)
- Results
- Not posted in the source record
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 treat Adult Attention Deficit Hyperactivity Disorder (ADHD) in methadone patients.
Detailed description
This project is a three armed double-blind, placebo-controlled, randomized trial comparing the efficacy of MPH and BPR, relative to each other and to placebo, for treating persistent ADHD in methadone-maintained patients. One hundred and twenty subjects, will be randomized to receive either MPH, BPR, or placebo with equal probability. Randomization will be stratified by site, and whether or not cocaine is also being used. Efficacy will be measured by treatment retention, reduction in illicit drug use and drug craving, improvement of ADHD symptoms and overall functional status.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| METHYLPHENIDATE | Active comparator | Drug: MethylphenidateMethylphenidate |
| BUPROPION | Active comparator | Drug: BupropionBupropion |
| PLACEBO | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Individuals who meet DSM-IV criteria for opiate dependence and are currently maintained on methadone
- Patients must meet DSM-IV criteria for persistent adult ADHD
- Must be on stable methadone dose for at least 3 weeks
- Individuals positive for HIV will not be excluded.
Key exclusion criteria (12 listed)
- Patients meeting DSM-IV criteria for current psychiatric disorders (other than ADHD or substance abuse) which requires psychiatric intervention
- Patients who are physiologically dependent on either sedatives or alcohol such that they experience symptoms requiring medical attention during periods of abstinence or significant reduction in amount of use
- Individuals diagnosed with other forms of adult ADHD other than persistent, particularly substance-induced ADHD
- Those who have an unstable medical condition which might make participation hazardous, including but not restricted to: uncontrolled hypertension, (SBP >160, DBP>100, PULSE >110), uncontrolled liver disease, uncontrolled diabetes, acute hepatitis, uncontrolled heart disease as indicated by history or abnormal ECG, glaucoma, or history of urinary retention or seizures, or advanced AIDS will not be included
- Patients who are taking prescription psychotropic medications other than methadone
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 |
|---|---|---|
| MethylphenidateMethylphenidate 80mg/day | Drug | METHYLPHENIDATE |
| BupropionBupropion 400mg/day | Drug | BUPROPION |
| PlaceboPlacebo | Other | PLACEBO |
Primary outcome
Cocaine use based on urine toxicology
Time frame: collected 3 times per week for 12 weeks of the trial or length of study participation
ADHD symptom severity based on the ADHD Rating scale score
Time frame: measured once per week for 12 weeks or length of study participation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2019.
- Background: PubMed 17088222Brooks DJ, Vosburg SK, Evans SM, Levin FR. Assessment of cognitive functioning of methadone-maintenance patients: impact of adult ADHD and current cocaine dependence. J Addict Dis. 2006;25(4):15-25. doi: 10.1300/J069v25n04_02.
- Results publication: PubMed 16102908Levin FR, Evans SM, Brooks DJ, Kalbag AS, Garawi F, Nunes EV. Treatment of methadone-maintained patients with adult ADHD: double-blind comparison of methylphenidate, bupropion and placebo. Drug Alcohol Depend. 2006 Feb 1;81(2):137-48. doi: 10.1016/j.drugalcdep.2005.06.012. Epub 2005 Aug 15.
- Substance and Research Service of the Division on Substance Abuse of the NYSPILink provided by the sponsor.
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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.
Frances R Levin, M.D. principal investigator
Research Foundation for Mental Hygiene, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Methylphenidate and Bupropion in people with ADHD and Opioid-Related Disorders, run by New York State Psychiatric Institute 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 4 inclusion and 12 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 23 Apr 2019. 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. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cocaine use based on urine toxicology (time frame: collected 3 times per week for 12 weeks of the trial or length of study participation). 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 NCT00061087, 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 23 Apr 2019.