Methylphenidate Studies for Drug Abuse Vulnerability Molecular Genentics

NCT00247689 | Terminated

• 2 other identifiers: 99990538105-DA-N381
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Substance Abuse

Keywords

Ritalin; Substance Abuse; Allelic Variants; Genotype; Addiction-Associated Human Gene Variants; Methylphenidate

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Self-reported White/Caucasian or Black/African American individual who have participated in the protocol #148 (90-DA-N448) in order to obtain the molecular genetic variables needed in the current study. We will contact only those individuals (substance abusers, non-substance abusing controls, and family members if the proband does not qualify) who have participated in study #148 (90-DA-N448) at times when their consent included written agreement to be contacted at a later date and are enrolled at the NIDA Intramural Research Program.

You may not qualify if:

• Do NOT have a history of
• Seizures,
• Head injury resulting in unconsciousness and/or requiring hospitalization
• Cardiovascular abnormalities (i.e. murmur)
• Uncontrolled or untreated hypertension
• Diastolic \>95 mmHg and/or Systolic \> 145 mmHg
• Clinically significant anxiety, depression, and/or panic disorder
• Coronary artery disease.
• History of known coronary artery disease,
• History of a prior myocardial infarction or stroke.
• An 12 lead EKG will be done during screening (no more than three months prior to enrollment), reviewed by an M.D, and may be sent to an outside cardiologist for manual reading.
• EKG abnormalities which will EXCLUDE a subject will include the following: QTc interval \> 450 ms or changes suggesting acute ischemia, second or third degree heart block, left bundle branch block, atrial fibrillation, signs of left ventricular hypertrophy or other clinically important arrhythmias.
• Dependence on methylphenidate or a psychostimulant
• History of an adverse reaction to cocaine, methylphenidate, amphetamine, other psychostimulant, herb and/or over the counter medication
• Urine sample positive for a psychostimulant on the day of the study. (An observed urine specimen will be tested on the day of the study)

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): lead

Study Sites (1)

National Institute on Drug Abuse

Baltimore, Maryland, 21224, United States

Location

Related Publications (3)

• Brown WA, Corriveau DP, Ebert MH. Acute psychologic and neuroendocrine effects of dextroamphetamine and methylphenidate. Psychopharmacology (Berl). 1978 Jul 6;58(2):189-95. doi: 10.1007/BF00426906. No abstract available.

  PMID: 98790 BACKGROUND

• Clark CR, Geffen GM, Geffen LB. Catecholamines and attention. II: Pharmacological studies in normal humans. Neurosci Biobehav Rev. 1987 Winter;11(4):353-64. doi: 10.1016/s0149-7634(87)80007-6.

  PMID: 3325865 BACKGROUND

• Evans WE, McLeod HL. Pharmacogenomics--drug disposition, drug targets, and side effects. N Engl J Med. 2003 Feb 6;348(6):538-49. doi: 10.1056/NEJMra020526. No abstract available.

  PMID: 12571262 BACKGROUND

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• George R Uhl, M.D.

  National Institute on Drug Abuse (NIDA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2005
• First Posted: November 2, 2005
• Study Start: December 22, 2004
• Study Completion: February 27, 2015
• Last Updated: December 12, 2019

Record last verified: 2015-02-27

Locations

US (1)