ADHDPhase 4NCT01673594
Prevention of Stimulant-Induced Euphoria With an Opioid Receptor Antagonist
A Phase 4 study testing SODAS MPH and Naltrexone in people with ADHD and Stimulant-Induced Euphoria, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of this study is to a) assess the efficacy of naltrexone in preventing stimulant-induced euphoria in adults with ADHD, b) assess whether naltrexone will interfere with the clinical efficacy of stimulants in treating adults with ADHD, c) assess whether naltrexone will interfere with the effects of… Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- ADHD, Stimulant-Induced Euphoria
- What is being tested?
- SODAS MPH and Naltrexone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Jun 2015
- Phase
- Phase 4
- 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 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female outpatients
- age 18-30
- diagnosis of ADHD by DSM-IV, per clinical evaluation and confirmed by structured interview
- likeability response (> 5) on Question #2 of the DRQ-S after an initial test dose of 60 mg of IR MPH.
- Baseline ADHD severity of > 20 on the Adult ADHD Investigator System Report Scale (AISRS)
- Able to participate in blood draws and to swallow pills.
- Subjects must be considered reliable reporters, must understand the nature of the study and must sign an informed consent document
Who cannot join
- Any current (last month), non-ADHD Axis I psychiatric conditions
- Ham-D > 16, BDI > 19, or Ham-A > 21
- Any clinically significant chronic medical condition
- any cardiovascular disease or hypertension
- Clinically significant abnormal baseline laboratory values
- I.Q. < 80)
Show all 16Show fewer
- Organic brain disorders
- Seizures or tics
- Pregnant or nursing females
- Clinically unstable psychiatric conditions (i.e. suicidal behaviors, psychosis)
- Current or recent (within the past year) substance abuse/dependence
- patients on other psychotropics
- Current or prior adequate treatment with MPH
- known hypersensitivity to methylphenidate
- Current opioid use (by history and urine screen) or potential need for opioid analgesics during the study
- acute hepatitis or liver failure (baseline blood tests).
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
The purpose of this study is to a) assess the efficacy of naltrexone in preventing stimulant-induced euphoria in adults with ADHD, b) assess whether naltrexone will interfere with the clinical efficacy of stimulants in treating adults with ADHD, c) assess whether naltrexone will interfere with the effects of stimulants on neurotransmitter activity. We predict that naltrexone will successfully prevent stimulant-induced euphoria without interfering with the ability of stimulants to effectively treat ADHD in adults. This study will be an 8 -week trial with young adults (18-24) with ADHD.
- Conditions
- ADHD, Stimulant-Induced Euphoria
- Being tested
- SODAS MPH, Naltrexone
- Keywords
- ADHD, Naltrexone, SODAS MPH, Stimulant-Induced Euphoria, Substance Abuse, Adults
- 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.
SODAS MPHDrug
Also called Ritalin LA
Adults with ADHD will receive open-label SODAS MPH
NaltrexoneDrug
Also called Naltrexone HCl
Subjects randomized to the "active" double-blind group will receive Naltrexone HCl
| Study group | Role | What they receive |
|---|---|---|
| Naltrexone | Experimental | Arm 1: Naltrexone + SODAS MPH Receives: Drug: SODAS MPH; Drug: Naltrexone |
| Placebo | Placebo comparator | Arm 2: Placebo + SODAS MPH Receives: Drug: SODAS MPH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Score on AISRS From Baseline to Week 6
The Adult ADHD Investigator System Report Scale (AISRS) is an 18-item, DSM-IV symptom Likert scale that measures ADHD symptoms in adults. Each of the individual symptoms of ADHD is rated from 0 to 3 on a scale of severity (3 being more severe symptoms). Total scores range from 0 to 54; higher scores indicate greater symptom severity. Change was calculated as value at baseline minus value at 6 weeks.
Measured: Baseline and 6 Weeks
Safety
Number of adverse events throughout the course of the study
Measured: 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2012 (estimated)
- Study startSep 2012
- Primary completionJun 2015
- Study completionJun 2015
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 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Thomas J. Spencer, MD, Massachusetts General Hospital
- Investigators
- Thomas J Spencer, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01673594
- Sponsor's protocol ID
- 2012-P-000918
- Status last verified
- Oct 2016
- First submitted
- 21 Jun 2012
- Last updated
- 30 Nov 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Spencer TJ, Bhide P, Zhu J, Faraone SV, Fitzgerald M, Yule AM, Uchida M, Spencer AE, Hall AM, Koster AJ, Feinberg L, Kassabian S, Storch B, Biederman J. The Mixed Opioid Receptor Antagonist Naltrexone Mitigates Stimulant-Induced Euphoria: A Double-Blind, Placebo-Controlled Trial of Naltrexone. J Clin Psychiatry. 2018 Mar/Apr;79(2):17m11609. doi: 10.4088/JCP.17m11609.
PubMed 29617066Spencer TJ, Bhide P, Zhu J, Faraone SV, Fitzgerald M, Yule AM, Uchida M, Spencer AE, Hall AM, Koster AJ, Biederman J. Opiate Antagonists Do Not Interfere With the Clinical Benefits of Stimulants in ADHD: A Double-Blind, Placebo-Controlled Trial of the Mixed Opioid Receptor Antagonist Naltrexone. J Clin Psychiatry. 2018 Jan/Feb;79(1):16m11012. doi: 10.4088/JCP.16m11012.
PubMed 28640990
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Stimulant-Induced Euphoria With an Opioid Receptor Antagonist
- ClinicalTrials.gov ID
- NCT01673594
- Acronym / sponsor ID
- 2012-P-000918
- Conditions
- ADHD, Stimulant-Induced Euphoria
- Keywords
- ADHD, Naltrexone, SODAS MPH, Stimulant-Induced Euphoria, Substance Abuse, Adults
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Sep 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 28 Aug 2012 (estimated)
- Results
- Posted 30 Nov 2016
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 a) assess the efficacy of naltrexone in preventing stimulant-induced euphoria in adults with ADHD, b) assess whether naltrexone will interfere with the clinical efficacy of stimulants in treating adults with ADHD, c) assess whether naltrexone will interfere with the effects of stimulants on neurotransmitter activity. We predict that naltrexone will successfully prevent stimulant-induced euphoria without interfering with the ability of stimulants to effectively treat ADHD in adults. This study will be an 8 -week trial with young adults (18-24) with ADHD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Naltrexone | Experimental | Drug: SODAS MPH, Drug: NaltrexoneArm 1: Naltrexone + SODAS MPH |
| Placebo | Placebo comparator | Drug: SODAS MPHArm 2: Placebo + SODAS MPH |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male and female outpatients
- age 18-30
- diagnosis of ADHD by DSM-IV, per clinical evaluation and confirmed by structured interview
- likeability response (> 5) on Question #2 of the DRQ-S after an initial test dose of 60 mg of IR MPH.
- Baseline ADHD severity of > 20 on the Adult ADHD Investigator System Report Scale (AISRS)
Key exclusion criteria (16 listed)
- Any current (last month), non-ADHD Axis I psychiatric conditions
- Ham-D > 16, BDI > 19, or Ham-A > 21
- Any clinically significant chronic medical condition
- any cardiovascular disease or hypertension
- Clinically significant abnormal baseline laboratory values
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 |
|---|---|---|
| SODAS MPHAlso: Ritalin LAAdults with ADHD will receive open-label SODAS MPH | Drug | Naltrexone, Placebo |
| NaltrexoneAlso: Naltrexone HClSubjects randomized to the "active" double-blind group will receive Naltrexone HCl | Drug | Naltrexone |
Primary outcome
Change in Score on AISRS From Baseline to Week 6
Time frame: Baseline and 6 Weeks
The Adult ADHD Investigator System Report Scale (AISRS) is an 18-item, DSM-IV symptom Likert scale that measures ADHD symptoms in adults. Each of the individual symptoms of ADHD is rated from 0 to 3 on a scale of severity (3 being more severe symptoms). Total scores range from 0 to 54; higher scores indicate greater symptom severity. Change was calculated as value at baseline minus value at 6 weeks.
Safety
Time frame: 6 Weeks
Number of adverse events throughout the course of the study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29617066Spencer TJ, Bhide P, Zhu J, Faraone SV, Fitzgerald M, Yule AM, Uchida M, Spencer AE, Hall AM, Koster AJ, Feinberg L, Kassabian S, Storch B, Biederman J. The Mixed Opioid Receptor Antagonist Naltrexone Mitigates Stimulant-Induced Euphoria: A Double-Blind, Placebo-Controlled Trial of Naltrexone. J Clin Psychiatry. 2018 Mar/Apr;79(2):17m11609. doi: 10.4088/JCP.17m11609.
- Derived from this study: PubMed 28640990Spencer TJ, Bhide P, Zhu J, Faraone SV, Fitzgerald M, Yule AM, Uchida M, Spencer AE, Hall AM, Koster AJ, Biederman J. Opiate Antagonists Do Not Interfere With the Clinical Benefits of Stimulants in ADHD: A Double-Blind, Placebo-Controlled Trial of the Mixed Opioid Receptor Antagonist Naltrexone. J Clin Psychiatry. 2018 Jan/Feb;79(1):16m11012. doi: 10.4088/JCP.16m11012.
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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.
Thomas J Spencer, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing SODAS MPH and Naltrexone in people with ADHD and Stimulant-Induced Euphoria, run by Massachusetts General Hospital 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 7 inclusion and 16 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 30 Nov 2016. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 30 Nov 2016). 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?
Change in Score on AISRS From Baseline to Week 6 (time frame: Baseline and 6 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 NCT01673594, 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 30 Nov 2016.