Status:
TERMINATED
Methylphenidate Studies for Drug Abuse Vulnerability Molecular Genentics
Lead Sponsor:
National Institute on Drug Abuse (NIDA)
Conditions:
Substance Abuse
Eligibility:
All Genders
21-50 years
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 tende...
Detailed Description
Scientific Goals. We and others have now identified several human chromosomal regions that contain genetic markers that have been associated with vulnerability to substance abuse/dependence in several...
Eligibility Criteria
Inclusion
- 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:
- 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)
- 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
- Diagnosed with a movement disorder
- Diagnosed with glaucoma
- Currently taking any of the following: monoamine oxidase inhibitors (within 2 weeks of protocol participation), insulin, and/or a psychostimulant
- A major medical diagnosis (i.e. .stroke, rheumatoid arthritis on therapy, diabetes)
- 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.
- 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
Exclusion
Key Trial Info
Start Date :
December 22 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 27 2015
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00247689
Start Date
December 22 2004
End Date
February 27 2015
Last Update
December 12 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Institute on Drug Abuse
Baltimore, Maryland, United States, 21224