ADHDPhase 4NCT01721330
A Double-Blind Comparison of Naltrexone and Placebo in Adults With Attention Deficit Hyperactivity Disorder
A Phase 4 study testing Naltrexone in people with ADHD and Attention Deficit Hyperactivity Disorder, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The primary aim of this study is to assess whether naltrexone as a monotherapy is effective in treating ADHD in adults. Medications that increase dopamine are often effective treatments for ADHD. Since naltrexone is a kappa opioid receptor antagonist, it increases dopamine in the brain. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- ADHD, Attention Deficit Hyperactivity Disorder
- What is being tested?
- Naltrexone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Feb 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female outpatients 18-55 years of age.
- Diagnosis of ADHD, by Diagnostic and Statistical Manual-IV (DSM-IV) by clinical evaluation by an expert clinician.
- A CGI of 7 (among the most extremely ill patients) at the pre-baseline visit is exclusionary, and any subject who presents a CGI-S of 7 at any point during the study will be removed from participation.
- Subjects presenting with a CGI-S score of 6 (severely ill) at two consecutive visits after week 2 will be dropped from the study (i.e. A subject with a CGI of 6 at his/her week 3 visit and at week 4 visit will be dropped from the study at the week 4 visit). Subjects who are dropped for severe or worsening symptoms after exposure to the study medication will receive free follow up care as described in the detailed protocol and protocol summary.
- Subjects treated for anxiety disorders and depression who are on a stable medication regimen for at least one month, and who have a disorder-specific CGI-Severity score ≤ 3 (mildly ill) and who have a score on the Hamilton-Depression and Hamilton-Anxiety rating scales below 15 (mild range).
Who cannot join
- Any clinically unstable psychiatric conditions including any history of psychosis or mania, suicidality, sociopathy, criminality, or delinquency.
- Current (last 3 months) substance use disorders (alcohol or drugs),
- Medical condition or treatment that will either jeopardize subject safety or affect the scientific merit of the study including cardiovascular disease, current untreated hypertension, or history of renal or hepatic impairment.
- A condition that will or may require treatment with opioid analgesics.
- Clinically significant abnormal baseline laboratory LFT's, which is defined as LFT's greater than the ULN.
- Mental retardation (IQ < 80).
Show all 14Show fewer
- Organic brain disorders including delirium, dementia, seizures, stroke, neurosurgery, and head trauma with loss of consciousness.
- Pregnant or nursing females.
- Subjects with current adequate treatment for ADHD.
- Any other concomitant medication with primarily central nervous system activity other than specified in Concomitant Medication portion of the protocol (a stable and effective treatment regimen of an SSRI or benzodiazepine is permitted per clinical review).
- Non-English speaking subjects will not be allowed into the study for the following reasons:
- The assessment instruments are unavailable and have not been adequately standardized in other languages;
- Even if such translation services were available, the assessments in the English language conducted by English-speaking clinicians and raters with English-speaking subjects are already extremely time-consuming, lasting many hours, making it unfeasible, unrealistic, and of dubious clinical validity to conduct them with a translator with non-English-speaking subjects;
- Psychiatric questionnaires and evaluations are taxing, and adding the complexity of a translator has the potential to make the patient experience even more exhausting.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Cambridge, Massachusetts, 02138
About this study
The primary aim of this study is to assess whether naltrexone as a monotherapy is effective in treating ADHD in adults. Medications that increase dopamine are often effective treatments for ADHD. Since naltrexone is a kappa opioid receptor antagonist, it increases dopamine in the brain. The investigators predict that naltrexone as a monotherapy will be effective for ADHD symptoms in adults with ADHD.
The investigators also plan to assess the effects of naltrexone on dopamine as measured by changes in serum prolactin. The investigators predict that naltrexone will increase dopamine as indexed by decreases in serum prolactin. This study will be a six-week, double-blind, placebo-controlled pilot study with adults 18-55 years of age with ADHD.
Read the detailed description
This will be a six-week, randomized, double-blind, placebo-controlled, parallel design study of adult ADHD with naltrexone monotherapy. Eligible and consenting subjects will be recruited into the study. The first visit will consist of a meeting with a study clinician who obtains consent, assesses for eligibility, and completes study rating scales. After this evaluation, subjects will complete a neuropsychological assessment and study rating scales (two hours; this visit can take place over multiple days, if necessary). Subjects will then be randomized to naltrexone (50 mg) once a day with breakfast or placebo at a ratio of 1:1 to be increased, if tolerated, to 100 mg by week 1.
Blood will be drawn for prolactin, basic metabolic panel, CBC, and LFT's at pre-baseline and upon completion of the study. Ten cc's (approximately two teaspoons) of blood will be required for the basic metabolic panel, CBC, and LFT's at each drawing. An additional five cc's (approximately one teaspoon) of blood will be required for laboratory testing of prolactin levels at each drawing. Dipstick urine drug testing will be done at pre-baseline.
Women of child bearing age will also have a urine pregnancy test at pre-baseline.
Although every effort will be made to encourage subjects to keep regularly scheduled appointments, in the event that a subject is unable to come into the office within a reasonable timeframe of a scheduled visit, and the treating research clinician feels that subject safety will not be jeopardized by doing so, the clinician can conduct the visit with the subject over the telephone. However, study evaluation visit (pre-baseline), baseline visit, mid-point visit (week 3), or the final study visit may not be conducted over the phone. Additionally, phone visits may not occur for two consecutive visits.
- Conditions
- ADHD, Attention Deficit Hyperactivity Disorder
- Being tested
- Naltrexone, Placebo
- Keywords
- ADHD, Attention Deficit Hyperactivity Disorder, Psychopharmacology, Psychiatry, Non-stimulant treatment
- 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.
NaltrexoneDrug
Up to 100mg of Naltrexone once a day for 6 weeks
PlaceboDrug
Placebo twice a day for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Naltrexone | Active comparator | Active Naltrexone administered twice daily up to a maximum total dose of 100mg/day. Receives: Drug: Naltrexone |
| Placebo | Placebo comparator | Naltrexone-masked placebo administered twice daily up to a maximum total dose of 100mg/day. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Adult Investigator Symptom Rating Scale (AISRS) Score
The AISRS is an 18-item clinician rating scale to evaluate individual ADHD symptoms on a scale of 0 (none) to 3 (severe). The total sum ranges from 0 (no ADHD symptoms) to 54 (extremely severe ADHD symptoms). We measured the change in AISRS score from baseline to week 6.
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 posted5 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionFeb 2015
- Study completionFeb 2015
Why it stopped: Competing studies
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 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- 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
- NCT01721330
- Sponsor's protocol ID
- 2012P-002252
- Status last verified
- Apr 2016
- First submitted
- 30 Oct 2012
- Last updated
- 27 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind Comparison of Naltrexone and Placebo in Adults With Attention Deficit Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT01721330
- Acronym / sponsor ID
- 2012P-002252
- Conditions
- ADHD, Attention Deficit Hyperactivity Disorder
- Keywords
- ADHD, Attention Deficit Hyperactivity Disorder, Psychopharmacology, Psychiatry, Non-stimulant treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Competing studies
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 5 Nov 2012 (estimated)
- Results
- Posted 12 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim of this study is to assess whether naltrexone as a monotherapy is effective in treating ADHD in adults. Medications that increase dopamine are often effective treatments for ADHD. Since naltrexone is a kappa opioid receptor antagonist, it increases dopamine in the brain. The investigators predict that naltrexone as a monotherapy will be effective for ADHD symptoms in adults with ADHD.
The investigators also plan to assess the effects of naltrexone on dopamine as measured by changes in serum prolactin. The investigators predict that naltrexone will increase dopamine as indexed by decreases in serum prolactin. This study will be a six-week, double-blind, placebo-controlled pilot study with adults 18-55 years of age with ADHD.
Detailed description
This will be a six-week, randomized, double-blind, placebo-controlled, parallel design study of adult ADHD with naltrexone monotherapy. Eligible and consenting subjects will be recruited into the study. The first visit will consist of a meeting with a study clinician who obtains consent, assesses for eligibility, and completes study rating scales. After this evaluation, subjects will complete a neuropsychological assessment and study rating scales (two hours; this visit can take place over multiple days, if necessary). Subjects will then be randomized to naltrexone (50 mg) once a day with breakfast or placebo at a ratio of 1:1 to be increased, if tolerated, to 100 mg by week 1.
Blood will be drawn for prolactin, basic metabolic panel, CBC, and LFT's at pre-baseline and upon completion of the study. Ten cc's (approximately two teaspoons) of blood will be required for the basic metabolic panel, CBC, and LFT's at each drawing. An additional five cc's (approximately one teaspoon) of blood will be required for laboratory testing of prolactin levels at each drawing. Dipstick urine drug testing will be done at pre-baseline.
Women of child bearing age will also have a urine pregnancy test at pre-baseline.
Although every effort will be made to encourage subjects to keep regularly scheduled appointments, in the event that a subject is unable to come into the office within a reasonable timeframe of a scheduled visit, and the treating research clinician feels that subject safety will not be jeopardized by doing so, the clinician can conduct the visit with the subject over the telephone. However, study evaluation visit (pre-baseline), baseline visit, mid-point visit (week 3), or the final study visit may not be conducted over the phone. Additionally, phone visits may not occur for two consecutive visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Naltrexone | Active comparator | Drug: NaltrexoneActive Naltrexone administered twice daily up to a maximum total dose of 100mg/day. |
| Placebo | Placebo comparator | Drug: PlaceboNaltrexone-masked placebo administered twice daily up to a maximum total dose of 100mg/day. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male and female outpatients 18-55 years of age.
- Diagnosis of ADHD, by Diagnostic and Statistical Manual-IV (DSM-IV) by clinical evaluation by an expert clinician.
- A CGI of 7 (among the most extremely ill patients) at the pre-baseline visit is exclusionary, and any subject who presents a CGI-S of 7 at any point during the study will be removed from participation.
- Subjects presenting with a CGI-S score of 6 (severely ill) at two consecutive visits after week 2 will be dropped from the study (i.e. A subject with a CGI of 6 at his/her week 3 visit and at week 4 visit will be dropped from the study at the week 4 visit). Subjects who are dropped for severe or worsening symptoms after exposure to the study medication will receive free follow up care as described in the detailed protocol and protocol summary.
- Subjects treated for anxiety disorders and depression who are on a stable medication regimen for at least one month, and who have a disorder-specific CGI-Severity score ≤ 3 (mildly ill) and who have a score on the Hamilton-Depression and Hamilton-Anxiety rating scales below 15 (mild range).
Key exclusion criteria (14 listed)
- Any clinically unstable psychiatric conditions including any history of psychosis or mania, suicidality, sociopathy, criminality, or delinquency.
- Current (last 3 months) substance use disorders (alcohol or drugs),
- Medical condition or treatment that will either jeopardize subject safety or affect the scientific merit of the study including cardiovascular disease, current untreated hypertension, or history of renal or hepatic impairment.
- A condition that will or may require treatment with opioid analgesics.
- Clinically significant abnormal baseline laboratory LFT's, which is defined as LFT's greater than the ULN.
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 |
|---|---|---|
| NaltrexoneUp to 100mg of Naltrexone once a day for 6 weeks | Drug | Naltrexone |
| PlaceboPlacebo twice a day for 6 weeks | Drug | Placebo |
Primary outcome
Change in Adult Investigator Symptom Rating Scale (AISRS) Score
Time frame: 6 weeks
The AISRS is an 18-item clinician rating scale to evaluate individual ADHD symptoms on a scale of 0 (none) to 3 (severe). The total sum ranges from 0 (no ADHD symptoms) to 54 (extremely severe ADHD symptoms). We measured the change in AISRS score from baseline to week 6.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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 Naltrexone in people with ADHD and Attention Deficit Hyperactivity Disorder, 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 5 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: stopped early, as of the sponsor's last update on 27 May 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 12 Apr 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 Adult Investigator Symptom Rating Scale (AISRS) Score (time frame: 6 weeks). 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 27 May 2016.