Safety Study to Assess Atomoxetine With MA Abusers and Healthy Controls
Status:
Completed
Trial end date:
2012-08-01
Target enrollment:
Participant gender:
Summary
Methamphetamine (MA) abuse is a national public health concern. People who are dependent on
MA have problems with mental functions (e.g., learning, remembering, focusing attention,
solving problems). Such problems can interfere with their treatment for MA abuse, and thereby
may promote continued drug use. While the effects of MA have been studied in rodents and
non-human primates, its effects on the human brain have not been well characterized.
This is a study of nontreatment seeking individuals who use MA compared to individuals who do
not use MA(control participants). 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, placebocontrolled,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
structuraland 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 atomoxotime 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.