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NCT00261872 · ClinicalTrials.gov registry record · Phase 4
Treatment of Patients With Alcoholism and Attention Deficit Disorder
A Phase 4 study, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- Completed
- Registry status
- Phase 4
- Development phase
- 100
- Enrollment target
NCT00261872 is a Phase 4 study that has completed, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA). The registered enrollment target is 100 participants.
The verdict
NCT00261872, a Phase 4 study, has completed, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA).
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 100 participants
- Enrollment target
Study Summary
This study of persons with both alcoholism and ADHD will determine whether adding the drug methylphenidate to a standard treatment program will decrease alcohol use. In approximately half of patients with ADHD, symptoms persist into adulthood, and the untreated condition is associated with a significantly increased incidence of substance use disorder. Also, more than one-third of adults with substance use disorder have symptoms of ADHD. This study will evaluate the effectiveness of adding methylphenidate to a standard alcohol treatment program in improving patients' treatment compliance and decreasing adverse consequences of drinking, as well as monitoring their attention deficit/hyperactivity symptoms, People 21 to 65 years of age with alcoholism and attention deficit hyperactivity disorder (ADHD) may be eligible for this study. Participants are randomly assigned to receive either slow-release methylphenidate (an approved medication for ADHD) or placebo. All subjects participate in NIAAA's alcohol treatment program, which includes a standardized 12-week behavioral therapy course and treatment with naltrexone, a medication to prevent relapse. Patients are assessed once a week with the standard NIAAA treatment evaluation battery, including: * Timeline Followback: A validated self-report method to assess a person's drinking over a defined interval in time * Addiction Severity Index: A validated interview that measures problem severity in seven areas related to drug and alcohol abuse * Biomarkers for alcohol abuse * Conners Adult ADHD Rating Scale (a rating scale for ADHD symptoms and severity)
Interventions
- DRUG Methylphenidate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2005-12-01 |
| Est. Completion | 2007-04-09 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00261872
The ClinicalTrials.gov registry entry for NCT00261872 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute on Alcohol Abuse and Alcoholism (NIAAA), which has 93 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Methylphenidate is the first listed.
NCT00261872 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00261872 about?
NCT00261872 is a clinical study titled "Treatment of Patients With Alcoholism and Attention Deficit Disorder". This study of persons with both alcoholism and ADHD will determine whether adding the drug methylphenidate to a standard treatment program will decrease alcohol use. In approximately half of patients with ADHD, symptoms persist into adulthood, and the untreated condition is associated with a signifi...
What is the current status of trial NCT00261872?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 100 participants. The study started on 2005-12-01. Estimated completion is 2007-04-09.
What interventions are being tested in trial NCT00261872?
The interventions under investigation include: Methylphenidate (DRUG).
Who is sponsoring clinical trial NCT00261872?
This trial is sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA), which has 93 total clinical trials registered on ClinicalTrials.gov.
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