NCT00247689

Methylphenidate Studies for Drug Abuse Vulnerability Molecular Genentics

Terminated Last updated 12 December 2019

What this trial tests

trial in Substance Abuse in 31 participants. Terminated before completion.

Timeline

22 December 2004

27 February 2015

Quick facts

Lead sponsor	National Institute on Drug Abuse (NIDA)
Status	Terminated
Study type	OBSERVATIONAL
Enrollment	31
Start date	22 December 2004
Estimated completion	27 February 2015
Sites	1 location across United States

Conditions studied

• Substance Abuse — all drugs for Substance Abuse →

Sponsor

National Institute on Drug Abuse (NIDA)

Who can join

Adults 21 to 50, any sex, with Substance Abuse. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background:

* Research has shown that several human genes have been associated with vulnerability to substance abuse and dependence. However, little is known about how people with these genetic tendencies react to drugs in controlled settings.
* Methylphenidate, also known as Ritalin, is commonly prescribed for a number of conditions, including attention deficit disorder. Because methylphenidate is widely used in studies of brain chemistry and behavior and has relatively low risks associated with it use, researchers are interested in seeing how it affects the thinking processes of people with apparent genetic vulnerability to drug abuse.

Objectives:

\- To evaluate whether individuals with apparent genetic vulnerability to drug abuse react differently to methylphenidate than people who do not have this vulnerability.

Eligibility:

\- Individuals at least 18 years of age or older who have participated in the NIDA protocol Allelic Linkage in Substance Abuse.

Design:

* Participants will be asked to avoid using a number of over-the-counter medications, including antihistamines, cough medicines, and nasal decongestants, for 24 hours before the study day. Participants will also be asked to avoid consuming caffeinated beverages, nicotine or tobacco products, or alcohol on the morning of the day of the study, and will provide a urine sample at the start of the study to be tested for chemicals that may interfere with the study.
* Because of the nature of the study drug, participants will not be allowed to drive to the clinical center on the day of the study. (Return transportation will be arranged.)
* At the start of the study, participants will take two tablets (each 1 hour apart), and will not be told whether the tablets are the study drug or a placebo.
* Participants will give regular answers to questions about mood and thinking processes on a computer for approximately 5 hours. Blood samples will be taken during this part of the study.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.