An Assessment of the Safety of Varenicline in Methamphetamine-dependent Volunteers
Status:
Completed
Trial end date:
2009-09-01
Target enrollment:
Participant gender:
Summary
More people worldwide use amphetamine-type stimulants than any illicit drug besides cannabis,
and methamphetamine (MA) abuse and dependence is the fastest growing drug problem in the
United States. Much work remains in identifying an effective pharmacotherapy for MA
dependence. The neurobiological actions produced by MA involve dopamine (DA), serotonin, and
norepinephrine, but also include alterations to cholinergic neurotransmitter systems.
Candidate compounds that target acetylcholine (ACh) are attractive options for development
that have not received adequate attention. Varenicline is a drug that increases the release
of DA in the brain and it is logical to assume that it would to some extent compensate for
the reduction in these neurotransmitters that occurs in MA withdrawal.
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). We will take blood samples and test for these genes in order
to relate the findings to brain function.
This is a double-blind, placebo-controlled, within-subjects study to determine the safety and
tolerability of MA in MA-dependent volunteers treated with varenicline and placebo.