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Effects of Stimulant Dependence on Human Striatal Dopamine System - 15

Primary Purpose

Amphetamine-Related Disorders, Tobacco Use Disorder

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
radioactive substance
Sponsored by
National Institute on Drug Abuse (NIDA)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amphetamine-Related Disorders focused on measuring amphetamine dependence

Eligibility Criteria

21 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Friends Research Institute

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 20, 1999
Last Updated
January 10, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00000350
Brief Title
Effects of Stimulant Dependence on Human Striatal Dopamine System - 15
Official Title
Effects of Stimulant Dependence on Human Striatal Dopamine System
Study Type
Interventional

2. Study Status

Record Verification Date
March 1999
Overall Recruitment Status
Unknown status
Study Start Date
March 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute on Drug Abuse (NIDA)

4. Oversight

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amphetamine-Related Disorders, Tobacco Use Disorder
Keywords
amphetamine dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Masking
None (Open Label)
Enrollment
0 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
radioactive substance

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walter Ling, M.D.
Organizational Affiliation
Friends Research Institute, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Friends Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Effects of Stimulant Dependence on Human Striatal Dopamine System - 15

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