NCT01019707

Safety Assessment of Atomoxetine With MA IV Administration

A Study to Assess the Cardiovascular, Cognitive and Subjective Effects of Atomoxetine in Combination With Intravenous Methamphetamine

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: University of California, Los Angeles · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

This is a study of 4 nontreatment seeking individuals who were MA-dependent and the safety and tolerability of atomoxetine. This double-blind, placebo-controlled, within-subjects study is to determine the safety and tolerability of atomoxetine. 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 components of the study that will occur in the University of California Los Angeles (UCLA) General Clinical Research Center (GCRC). 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 components. During the inpatient components participants will receive alternating study drugs; atomoxetine or placebo and four sessions of IV MA administration or saline.

Detailed description

The safety of using atomoxetine in MA users will be characterized by measuring the cardiovascular effects of MA and by determining the occurrence of adverse reactions during treatment with atomoxetine and placebo. We will evaluate atomoxetine (0 and 40 mg, BID) and MA doses (0 and 30 mg, IV). Participants will be randomized to atomoxetine or matched placebo for 6 days. Study drug will be administered once daily at 40 mg/day on the first two study days, twice daily for days 3-5, \& once on day 6. After discharge from the first component, and at least a 2-week washout period, participants will be re-admitted to the UCLA GCRC and switched to the opposite study medication for an additional 6 days. Methamphetamine/saline will be administered non-contingently on component I day 13, and component II day 7, over 1 min using a syringe pump activated by the study physician or nurse practitioner in order to assess safety and tolerability of atomoxetine. During drug administration sessions, heart rate and blood pressure will be monitored frequently. A code team will respond if required. Vital signs must remain within values specified under Stopping Criteria for initiation of MA administration. The physician or nurse practitioner will administer the MA/placebo and will be available in-house on pager for at least 4 h after each infusion. In addition, heart rate and blood pressure will be assessed three times daily throughout the inpatient portion of the protocol.

Conditions

• Methamphetamine Abuse
• Methamphetamine Dependence

Interventions

Type	Name	Description
DRUG	Atomoxetine, then Placebo	As this is a within-subject, crossover design, all subjects complete both study medication assignments in a double-blind fashion. Based on random assignment to start on either atomoxetine or placebo, study drug will be administered once daily at 40 mg/day on the first 2 study days, then twice daily for the third, fourth and fifth study days, and once daily on the sixth study day.
DRUG	Placebo, then Atomoxetine	As this is a within-subject, crossover design, all subjects complete both study medication assignments in a double-blind fashion. Based on random assignment to start on either atomoxetine or placebo, study drug will be administered once daily at 40 mg/day on the first 2 study days, then twice daily for the third, fourth and fifth study days, and once daily on the sixth study day.

Timeline

• Start date: 2009-10-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2009-11-25
• Last updated: 2017-06-02
• Results posted: 2013-07-31

Locations

1 site across 1 country: United States