Safety Assessment of Atomoxetine With MA IV Administration
This is a study of 30 nontreatment seeking individuals who use MA compared to 30 individuals who do not use MA (control subjects). The study has three goals: 1. it aims to identify the brain regions and pathways that may contribute to the problems of MA abusers in performing mental tasks; 2. it will serve as a double-blind, placebo-controlled, within-subjects study to determine the safety and tolerability, and positive effects of MA in MA- abusing volunteers treated with atomoxetine or placebo; 3. It aims to compare the brain activity as measured by structural and functional magnetic resonance imaging (fMRI). These are noninvasive brain imaging procedures, that will be used to study brain function while control and MA using participants take atomoxetine or placebo and perform tests of memory and concentration.
MA abusing participants will undergo a 1-day outpatient screening and if it is safe for the participants to proceed with the study they will participate in two inpatient phases of the study that will occur in the UCLA research setting, the General Clinical Research Center. The first inpatient stay will be 15 days, and the second will be a 9 days stay that includes drug administration and assessments. There will be at least a two week interval between inpatient phases. During the inpatient phases participants will receive alternating study drugs; atomoxetine or placebo and four sessions of IV MA administration or placebo.
The study schedule for control participants will include a 1-day outpatient screening and two phases of outpatient administration of atomoxetine or placebo with a two week study drug free interval between the phases. Four to five of the outpatient study visits will involve cognitive tests and brain imaging studies.
In addition, current research has linked certain genes that are related to neurotransmitters with drug abuse and memory impairment (e.g., A1 allele for the D2 dopamine receptor and catechol-O-methyltransferase). Therefore blood samples will be obtained to test for these genes in order to relate the findings to brain function.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Study to Assess the Cardiovascular, Cognitive and Subjective Effects of Atomoxetine in Combination With Intravenous Methamphetamine|
- Cardiovascular parameters and adverse events [ Time Frame: Daily with IV MA infusion and medication ] [ Designated as safety issue: Yes ]
- Subjective effects will be assessed using visual-analogue scales. [ Time Frame: Daily with MA IV infusion and medication ] [ Designated as safety issue: No ]
|Study Start Date:||October 2009|
|Study Completion Date:||December 2010|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
|Placebo Comparator: Arm 1||
Based on random assignment, placebo tablets will be administered once daily at 40 mg/day on the first two study days, then twice daily for the third, fourth and fifth study days, and once daily on the sixth study day, then stop.
|Active Comparator: Arm 2||
Based on random assignment, atomoxetine tablets will be administered once daily at 40 mg/day on the first two study days, then twice daily for the third, fourth and fifth study days, and once daily on the sixth study day, then stop.
Other Name: Strattera
|United States, California|
|UCLA Semel Institute NPI|
|Los Angeles, California, United States, 90095|
|Principal Investigator:||Steven Shoptaw, PhD||University of California, Los Angeles|