Methylphenidate Studies for Drug Abuse Vulnerability Molecular Genentics

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00247689
First received: October 31, 2005
Last updated: July 10, 2014
Last verified: June 2014
  Purpose

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.

Condition
Substance Abuse

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Methylphenidate Studies for Drug Abuse Vulnerability Molecular Genentics

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 120
Study Start Date: December 2004
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

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.

EXCLUSION CRITERIA:

  1. Do NOT have a history of

    1. Seizures,
    2. Head injury resulting in unconsciousness and/or requiring hospitalization
    3. Cardiovascular abnormalities (i.e. murmur)
    4. Uncontrolled or untreated hypertension

      -Diastolic > 95 mmHg and/or Systolic > 145 mmHg

    5. Clinically significant anxiety, depression, and/or panic disorder
    6. 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.
    7. Dependence on methylphenidate or a psychostimulant
    8. History of an adverse reaction to cocaine, methylphenidate, amphetamine, other psychostimulant, herb and/or over the counter medication
    9. 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)
    10. Clinically significant abnormal renal and/or liver function

      • Renal (lab cut off ): BUN > 35mg/dl; Cr > 2.0 mg/dl
      • Liver (lab cut off): AST > 200 U/L; ALT > 200 U/L; Alk P > 200 U/L; GGT> 400 U/L
    11. Diagnosed with a movement disorder
    12. Diagnosed with glaucoma
    13. Currently taking any of the following: monoamine oxidase inhibitors (within 2 weeks of protocol participation), insulin, and/or a psychostimulant
    14. A major medical diagnosis (i.e. .stroke, rheumatoid arthritis on therapy, diabetes)
  2. Competent to give informed consent. Competency of research participation at the NIDA will be determined by a Shipley Institute of Living Scales estimated IQ score of 80 or greater and an SCL-90-R Global Severity Index T-score of 70 or less. Cognitive impairment will be defined using the Shipley Institute of Living Scale or WRAT (equivalent to WAIS-R IQ < 79). With individuals having SCL-90-R scores greater than 70 referred for evaluation to a Counselor or Physician before admission to the study can be complete. The counselor or physician using his/her clinical judgment will make 1 of 2 determinations: a) The applicant may continue with the screening process; b) The applicant is disqualified from participation in the study and an appropriate referral is made if indicated.
  3. To evaluate the understanding of the study, its risk and benefits, and how to withdrawal from the study at anytime will be determined by a Consent Quiz score of 80 percent or greater (answering 8 of 10 questions correctly) in NIDA participants
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00247689

Locations
United States, Maryland
National Institute on Drug Abuse
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Investigators
Principal Investigator: George R Uhl, M.D. National Institute on Drug Abuse (NIDA)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00247689     History of Changes
Other Study ID Numbers: 999905381, 05-DA-N381
Study First Received: October 31, 2005
Last Updated: July 10, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Ritalin
Substance Abuse
Allelic Variants
Genotype
Addiction-Associated Human Gene Variants
Methylphenidate

Additional relevant MeSH terms:
Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014