The purpose of this study is to study the genetically-mediated individual differences in acute responses to abused substances that contribute to the mechanisms through which specific human allelic variants influence individual differences in vulnerability to drug abuse/dependence...
Date First Received: October 31, 2005
Last Updated: October 31, 2005
Verified by: National Institute on Drug Abuse (NIDA), October 2005
Clinical Trial Phase: N/A | Start Date:
Overall Status: Not yet recruiting
Estimated Enrollment: 120
Brief Summary
Official Title: “Methylphenidate Studies for Drug Abuse Vulnerability Molecular Genetics”
Condition Keyword(s):
Intervention(s):
The purpose of this study is to study the genetically-mediated individual differences in acute responses to abused substances that contribute to the mechanisms through which specific human allelic variants influence individual differences in vulnerability to drug abuse/dependence.
Study Type: Observational
Study Design: Natural History, Cross-Sectional, Case Control, Prospective Study
Detailed Clinical Trial Description
Several human chromosomal regions that contain genetic markers have been associated with vulnerability to substance abuse/dependence in several different human populations. Little is known about the biological or behavioral mechanism by which specific molecular genetic characteristics enhance risks for drug disorders. This protocol will characterize individual differences in response to a one time oral dose of methylphenidate (30mg), study the genotype of individuals who display high- or low-level responses to this oral dose of methylphenidate administration, and allow the identification of which addiction-associated human gene variants alter subjective and physiologic responses to the administration of methylphenidate.
Methylphenidate was chosen due to: a) its wide clinical use, b) its low risk which are largely well understood as a result of its widespread use, and c) its prior usefulness to others as a probe for reward system activities in patients with dopaminergic brain lesions.
The dose of 30mg was chosen due to: a) prior success with this dose in a brain lesion candidate population, b) preliminary work with candidate gene studies in individuals administered oral doses of up to 60-70mg, and c) prior use of the intravenous dose of 0.5mg/kg with few reported adverse events by other workers in the field.
Intervention(s) in this Clinical Trial
- Drug: Methylphenidate
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Participated in NIDA-IRP-#1148
- Substance abuser
- White or African American
- Able to swallow pills
- Willing to have blood drawn
- Able to read
Exclusion Criteria:
- Hispanic or Latino, American Indian/Alaskan Native or Asian
- History of seizures or serious head injury
- Serious cardiovascular abnormalities
- Hypertension
- Clinically significant anxiety or a diagnosis of panic disorder by history
- A major medical diagnosis (e.g., coronary artery disease)
- History of dependence on methylphenidate
- History of an adverse reaction to psychostimulant drugs (e.g., cocaine, amphetamine, or methylphenidate)
- Positive urine sample for psychostimulants the morning of the study day
- Clinically-significant abnormalities of the renal or hepatic function
- History of adverse reactions to psychostimulants including over the counter stimulants
- History of movement disorder
- History of current psychostimulant dependence
- History of glaucoma
- Scores >75 on SCL-90 testing
- Recent use of monoamine oxidase inhibitors
- Individuals who are cognitively impaired
- Women who are of child bearing age and not using effective contraception
- Women who are pregnant or lactating (a urine test will be performed prior to the study session for all women participants
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 21 Years
Maximum Age for this Clinical Trial: 50 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: National Institute on Drug Abuse (NIDA)
Overall Clinical Trial Officials and Contacts
George Uhl, M.D., Ph.D. Principal Investigator National Institute on Drug Abuse (NIDA)
Overall Contact: Fred Snyder 410-550-1502 fsnyder@mail.nih.gov
Related Publications
References
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Additional Information
Information obtained from ClinicalTrials.gov on August 28, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00247689
Study ID Number: NIDA-IRP-381
ClinicalTrials.gov Identifier: NCT00247689
Health Authority: United States: Federal Government
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