Attention Deficit Hyperactivity Disorder (ADHD)NCT01270555
Efficacy Of Bupropion For Attention Deficit Hyperactivity Disorder (ADHD) In Adults
A study testing Bupropion SR in people with Attention Deficit Hyperactivity Disorder (ADHD) and Substance Use Disorder (SUD), run by Massachusetts General Hospital.
Trial summary
The investigators propose to conduct an open study to evaluate the efficacy and tolerability of Bupropion SR using clinically relevant doses in ADHD adults with a recent history of or current substance use disorders. We hypothesize that Bupropion SR will be effective in treating ADHD in this population. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder (ADHD), Substance Use Disorder (SUD)
- What is being tested?
- Bupropion SR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- May 1999to Jul 2001
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female outpatients 18 years old or older, up to 60 years old.
- Patients with the diagnosis of Attention Deficit Hyperactivity Disorder (ADHD), by DSM-IV, as manifested in clinical evaluation and confirmed by structured interview.
- Patients within the past 6 months known to abuse or to be dependent on alcohol or any drug (nicotine addiction not included)
Who cannot join
- Any clinically unstable medical condition
- Clinically significant abnormal baseline laboratory values
- Mental retardation (I.Q. <75) or Organic brain disorders
- Seizure disorder
- Patients with a history or an eating disorder including anorexia or bulimia nervosa
- Pregnant or nursing females
Show all 11Show fewer
- Patients with current bipolar disorder
- Psychotic disorder of any type
- Patients on psychotropics known to treat ADHD (i.e. stimulants, tricyclics)
- Patients receiving psychotherapy known to treat ADHD (i.e. cognitive or cognitive/behavioral psychotherapy)
- Patients demonstrating active withdrawal from substance abuse
About this study
Official title: Efficacy Of Bupropion SR For Attention Deficit Hyperactivity Disorder (ADHD) In Adults With Recent Past or Current Substance Use Disorders
The investigators propose to conduct an open study to evaluate the efficacy and tolerability of Bupropion SR using clinically relevant doses in ADHD adults with a recent history of or current substance use disorders. We hypothesize that Bupropion SR will be effective in treating ADHD in this population.
- Being tested
- Bupropion SR
- 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.
Bupropion SRDrug
Also called Wellbutrin
100mg capsules Initial dosing 100mgSR every morning, to be titrated to 200mgSR twice daily maximum
| Study group | Role | What they receive |
|---|---|---|
| Bupropion | Experimental | Not described Receives: Drug: Bupropion SR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) Score
Assesses 18 individual criteria symptoms using a severity grid (0 = not present, 3 = severe; overall minimum score = 0, maximum score = 54)
Measured: baseline and six weeks
Self-reported Weekly Substance Use
Number of subjects who self-report using at least one of illegal drugs or alcohol, at least once in a week.
Measured: baseline and six weeks
Secondary outcomes (5)
Clinical Global Impressions (CGI) Scale of Substance Use Disorder (SUD) Severity
CGI-S 1=not ill, 7=extremely ill
Measured: baseline and six weeks
Clinical Global Impressions (CGI) Scale of ADHD Severity
Global Severity (CGI-S) 1=not ill, 7=extremely ill
Measured: baseline and six weeks
Hamilton Anxiety Scale (HAM-A)
minimum score (least severe anxiety) = 0, maximum (most severe) = 56
Measured: baseline and six weeks
Hamilton Depression Scale (HAM-D)
minimum score (least severe depression) = 0, maximum score (most severe) = 84
Measured: baseline and six weeks
Beck Depression Inventory (BDI)
minimum score (least severe depression) = 0, maximum score (most severe) = 63
Measured: baseline and six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2011 (estimated)
- Study startMay 1999
- Primary completionJul 2001
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 Attention Deficit Hyperactivity Disorder (ADHD)Studies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Timothy Wilens, MD, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01270555
- Sponsor's protocol ID
- 1999-P-009198
- Status last verified
- Mar 2013
- First submitted
- 3 Jan 2011
- Last updated
- 8 Mar 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Of Bupropion SR For Attention Deficit Hyperactivity Disorder (ADHD) In Adults With Recent Past or Current Substance Use Disorders
- ClinicalTrials.gov ID
- NCT01270555
- Acronym / sponsor ID
- 1999-P-009198
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- May 1999
- Primary completion
- Jul 2001 (actual)
- First posted
- 5 Jan 2011 (estimated)
- Results
- Posted 25 Feb 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators propose to conduct an open study to evaluate the efficacy and tolerability of Bupropion SR using clinically relevant doses in ADHD adults with a recent history of or current substance use disorders. We hypothesize that Bupropion SR will be effective in treating ADHD 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 |
|---|---|---|
| Bupropion | Experimental | Drug: Bupropion SR |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male and female outpatients 18 years old or older, up to 60 years old.
- Patients with the diagnosis of Attention Deficit Hyperactivity Disorder (ADHD), by DSM-IV, as manifested in clinical evaluation and confirmed by structured interview.
- Patients within the past 6 months known to abuse or to be dependent on alcohol or any drug (nicotine addiction not included)
Key exclusion criteria (11 listed)
- Any clinically unstable medical condition
- Clinically significant abnormal baseline laboratory values
- Mental retardation (I.Q. <75) or Organic brain disorders
- Seizure disorder
- Patients with a history or an eating disorder including anorexia or bulimia nervosa
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 |
|---|---|---|
| Bupropion SRAlso: Wellbutrin100mg capsules Initial dosing 100mgSR every morning, to be titrated to 200mgSR twice daily maximum | Drug | Bupropion |
Primary outcome
Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) Score
Time frame: baseline and six weeks
Assesses 18 individual criteria symptoms using a severity grid (0 = not present, 3 = severe; overall minimum score = 0, maximum score = 54)
Self-reported Weekly Substance Use
Time frame: baseline and six weeks
Number of subjects who self-report using at least one of illegal drugs or alcohol, at least once in a week.
5 secondary outcomes
Clinical Global Impressions (CGI) Scale of Substance Use Disorder (SUD) Severity
Time frame: baseline and six weeks
Clinical Global Impressions (CGI) Scale of ADHD Severity
Time frame: baseline and six weeks
Hamilton Anxiety Scale (HAM-A)
Time frame: baseline and six weeks
Hamilton Depression Scale (HAM-D)
Time frame: baseline and six weeks
Beck Depression Inventory (BDI)
Time frame: baseline and six weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2013.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Bupropion SR in people with Attention Deficit Hyperactivity Disorder (ADHD) and Substance Use Disorder (SUD), run by Massachusetts General Hospital.
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 8 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
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 25 Feb 2011). 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?
Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) Score (time frame: baseline and six 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?
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 8 Mar 2013.