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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00000350
Other study ID # NIDA-3-0010-15
Secondary ID Y01-3-0010-15
Status Active, not recruiting
Phase Phase 1
First received September 20, 1999
Last updated January 10, 2017
Start date March 1999

Study information

Verified date March 1999
Source National Institute on Drug Abuse (NIDA)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether DAT availability, assessed by WIN binding, in the striatum is altered in cocaine or methamphetamine dependence. To determine whether DA synthesis capacity, assessed by FDOPA uptake, in the striatum is altered in Coc or Meth dependence. To determine whether the PET tracers, WIN or FDOPA, will differentiate Meth induced alterations from those induced by Coc use. To determine whether the PET characterization of striatal alterations observed at 3-5 days since last drug use persists at least 3 months after last drug use.


Description:

4-5 Day inpatient study. Participant will have scanned pictures (MRI & PET scans) taken of their brain after being injected with a small amount of WIN, a radioactive substance. Participants give daily urine samples and fill out health related questionnaires. It is important to determine whether the alterations characterized within one week of last drug use persist over a longer time period. Based on results of the studies from aims 1 & 2, we will decide which of the 2 probes, WIN or FDOPA-PET is the more sensitive index of stimulant-dependency-induced changes.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 21 Years to 50 Years
Eligibility Inclusion Criteria:

M/F, ages 21-50. Meet DSM-IV criteria for methamphetamine and nicotine dependence. Agree to conditions of the study and sign informed consent.

Exclusion Criteria:

Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nursing women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical conditions that deem participation to be unsafe.

Study Design

Masking: Open Label, Primary Purpose: Treatment


Intervention

Procedure:
radioactive substance


Locations

Country Name City State
United States Friends Research Institute Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

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