Safety Study to Assess Atomoxetine With MA Abusers and Healthy Controls

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.

Conditions

• Continuous Methamphetamine Dependence
• Methamphetamine Dependence in Remission

Interventions

DRUG

Atomoxetine

MA Group: Dispense 1 cap @ 8 AM on Treatment day 9 and 10 (total daily dose 40mg or 0); 1 cap SID @ 8 AM and 4 PM on day 11,12, and 13 (total daily dose 80mg or 0); 1 cap @ 8 AM on day 14 (total daily dose, 40mg or 0). Control Group Schedule: * Day 1: 40mg @ 8:00am * Day 2: 40mg @ 8:00am * Day 3: 40mg @ 8:00am, 40mg @ 8:00pm * Day 4: 40mg @ 8:00am, 40mg @ 8:00pm * Day 5: 40mg @ 8:00am, 40mg @ 8:00pm * Day 6: 40mg @ 8:00am = Testing day (fMRI scan \& cognitive testing session)

OTHER

Placebo

Control Group: Day 1: 40mg @ 8am Day 2: 40mg @ 8am Day 3: 40mg @ 8am, 40mg @ 8pm Day 4: 40 mg @ 8am, 40mg @ 8pm Day 5: 40mg @ 8am, 40 mg @ 8pm Day 6: 40 mg @ 8am = Testing day (fMRI scan \& cognitive testing session)

Sponsors & Collaborators

• University of California, Los Angeles

  lead OTHER

Principal Investigators

• Edythe London, Ph.D. · University of California, Los Angeles

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2009-08-31

Primary Completion

2012-08-31

Completion

2012-08-31