Methamphetamine Dependence Clinical Trial
Official title:
A Study to Assess the Cardiovascular, Cognitive and Subjective Effects of Atomoxetine in Combination With Intravenous Methamphetamine
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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