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NCT00261872
Treatment of Patients With Alcoholism and Attention Deficit Disorder
Phase 4 trial testing Methylphenidate in Alcoholism in 100 participants. Completed in 9 April 2007.
Quick facts
| Lead sponsor | National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 1 December 2005 |
| Estimated completion | 9 April 2007 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Methylphenidate (methylphenidate) — full drug profile →
Conditions studied
- Alcoholism — all drugs for Alcoholism →
- Attention Deficit Disorder — all drugs for Attention Deficit Disorder →
Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Who can join
Adults 21 to 65, any sex, with Alcoholism or Attention Deficit Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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)
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00261872
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00261872 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Last refreshed: 2 July 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00261872.
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