Status:
COMPLETED
An fMRI Study of SYN115 in Cocaine Dependent Subjects
Lead Sponsor:
Virginia Commonwealth University
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
The University of Texas Health Science Center, Houston
Conditions:
Cocaine Dependence
Eligibility:
All Genders
18-50 years
Phase:
EARLY_PHASE1
Brief Summary
The dopamine system is critical in modulation of reward and has been implicated in the initiation and maintenance of addiction (Volkow et al 2004). Medications that increase dopamine either directly o...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA: (1) 13 Male and 13 female subjects age 18 to 50 who currently meet DSM-IV criteria for cocaine dependence. (2) At least one cocaine positive urine during screening. (3) Female subjects: a negative pregnancy test.
- EXCLUSION CRITERIA: (1) current or past DSM-IV Axis I disorder other than substance abuse/dependence (2) any significant non-psychiatric medical illness requiring ongoing medical treatment (3) any clinically significant abnormality on EKG (4) hypertension (5) cardiovascular disease (6) substance dependence other than cocaine, marijuana, or nicotine within the last 3 months. (7) Positive breath alcohol (8) Positive urine drug screen for drugs other than cocaine or THC at the time of behavioral testing (9) For female subjects: known pregnancy or a positive pregnancy test or current breast feeding (10) Diagnosis of Adult Attention Deficit Disorder as determined by: a) meeting DSM-IV criteria for childhood ADHD, b) currently has impairing ADHD symptoms, c) ADHD symptoms can not have remitted at any period since childhood (11) HIV positive (12) I.Q. below 70 (13) Use of medications which affect the central nervous system (CNS) or could interact with SYN115. (13) History of pacemaker or metal implants or welding or metal work without protective eyewear.
Exclusion
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00783276
Start Date
October 1 2008
End Date
January 1 2013
Last Update
July 19 2019
Active Locations (1)
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1
University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030