Clinical trial NCT03973489: Effects of Genotype on Resting State Connectivity During Methamphetamine Administration
Official title: Effects of Genotype on Resting State Connectivity During Methamphetamine Administration
Conditions: Methamphetamine-dependence
Summary: Addiction to methamphetamine (MA) is a serious health problem in the United States. Right now, there are no medically approved treatments for MA dependence. More research is needed to understand how MA affects the brain and to eventually develop medical interventions for MA addiction. The purpose of the study is to learn more about how MA use affects the brain by investigating a receptor in the brain called trace amine-associated receptor 1 (TAAR1). The investigators are hoping to find out if individuals with certain versions of the brain receptor react differently when given MA. The TAAR1 receptor has two prevalent genetic variations due to a single nucleotide polymorphism. These are the wild type (WT) and a common variant (CV). Preliminary studies have shown that these variants produce different connectivity (resting state functional connectivity or RSFC) in the brains of individuals with MA use disorder (MUD), specifically that individuals with the CV genotype exhibit lower RSFC than WT. In this study, MA will be administered to individuals with MA use disorder and healthy controls in order to:
1. Determine the influence of CV vs. WT genotype on RSFC and craving in individuals with chronic MUD and healthy controls.
2. Determine the effect of acute methamphetamine or placebo administration on the interaction of CV vs WT genotype on RSFC, craving, cognitive control, attention and subjective experience in MUD and healthy controls.
Interventions:
description: On visits 2 and 3, subjects will undergo a baseline MRI scan approximately 1 hour after the start of each visit followed by drug administration (placebo or MA) and a second scan 1.5 hours after that.
name: Magnetic resonance imaging (MRI)
type: Behavioral
description: Study participants will receive an oral dose of methamphetamine hydrochloride on one of two scan days and an identical looking placebo in tablet form on the other scan day. Drug type will be randomized between the two visits. Participants will receive the following doses of methamphetamine hydrochloride in accordance with their weight: if weight is between 50-60 kg, 15 mg dose of methamphetamine hydrochloride will be administered. Similarly, for 60-80 kg, 20 mg dose; 80-100 kg, 25 mg dose; and 100+ kg, 30 mg dose.
name: Methamphetamine Hydrochloride Tablets
other_name: Desoxyn
type: Drug
description: Study participants will receive an oral dose of methamphetamine hydrochloride on one of two scan days and an identical looking placebo in tablet form on the other scan day. Drug type will be randomized between the two visits.
name: Placebo oral tablet
type: Drug
Study arms:
design_group_description: Wild Type (WT) Group: individuals who are WT for the TAAR1 gene
design_group_title: Wild Type (WT) MUD Group
design_group_type: Experimental
design_group_description: Common Variant (CV) Group: individuals who are hetero-or homozygous for the valine codon occurring at amino acid position 288, designated V288V, SNP on the TAAR1 gene
design_group_title: Common Variant (CV) MUD Group
design_group_type: Experimental
design_group_description: Wild Type (WT) Group: individuals who are WT for the TAAR1 gene
design_group_title: Wild Type (WT) Healthy Control Group
design_group_type: Experimental
design_group_description: Common Variant (CV) Group: individuals who are hetero-or homozygous for the V288V SNP on the TAAR1 gene
design_group_title: Common Variant (CV) Healthy Control Group
design_group_type: Experimental
Sponsor: Oregon Health & Science University
Collaborators: Portland VA Medical Center
Drug name mappings:
name: 盐酸去氧麻黄碱
lang: CN
name: Methamphetamine Hydrochloride
lang: EN
name: メタンフェタミン塩酸塩
lang: JP