A Double-Blind Comparison of Naltrexone and Placebo in Adults With Attention Deficit Hyperactivity Disorder

This is an interventional treatment trial for ADHD focused on measuring ADHD, Attention Deficit Hyperactivity Disorder, Psychopharmacology, Psychiatry, Non-stimulant treatment Read More

Inclusion Criteria

1. Male and female outpatients 18-55 years of age.
2. Diagnosis of ADHD, by Diagnostic and Statistical Manual-IV (DSM-IV) by clinical evaluation by an expert clinician.
3. 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.
4. 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.
5. 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).

Exclusion Criteria

1. Any clinically unstable psychiatric conditions including any history of psychosis or mania, suicidality, sociopathy, criminality, or delinquency.
2. Current (last 3 months) substance use disorders (alcohol or drugs),
3. 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.
4. A condition that will or may require treatment with opioid analgesics.
5. Clinically significant abnormal baseline laboratory LFT's, which is defined as LFT's greater than the ULN.
6. Mental retardation (IQ < 80).
7. Organic brain disorders including delirium, dementia, seizures, stroke, neurosurgery, and head trauma with loss of consciousness.
8. Pregnant or nursing females.
9. Subjects with current adequate treatment for ADHD.
10. 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).

11. Non-English speaking subjects will not be allowed into the study for the following reasons:

    1. The assessment instruments are unavailable and have not been adequately standardized in other languages;
    2. 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;
    3. Psychiatric questionnaires and evaluations are taxing, and adding the complexity of a translator has the potential to make the patient experience even more exhausting.