NCT01498549

Cognitive Effects of Atomoxetine in Humans: Genetic Moderators

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 21 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The overall goal of this study is to determine if atomoxetine treatment improves selective cognitive functions in abstinent cocaine users, compared to healthy controls. The study will also test if a functional variation of the NET promoter polymorphic region (NETpPR) moderates the cognitive effects of atomoxetine.

Detailed description

This will be a double-blind, placebo-controlled, crossover study, with cocaine use (cocaine users vs. healthy controls) and NET AAGG4 status (L4/ L4 vs. L4/S4 or S4/ S4 genotype) as the between-subject factors. Similar to previous studies, we propose to compare individuals with two copies of the L4 allele to participants with at least one S4 allele because only less than two percent of the general population is homozygous for the S4 allele. Forty cocaine users and 40 healthy controls will participate in 3 test sessions, where they will be assigned to 40 mg atomoxetine, 80 mg atomoxetine, or placebo. Outcome measures will include physiological, subjective, and cognitive performance measures. To date this study has 35 completers and currently in data analysis. (January 2016)

Conditions

• Addiction

Interventions

Type	Name	Description
DRUG	Atomoxetine	Atomoxetine 40mg and 80mg compared to the sugar pill
DRUG	Sugar Pill	Sugar pill compared to Atomoxetine 40mg and 80mg.

Timeline

• Start date: 2011-12-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2011-12-23
• Last updated: 2017-07-11
• Results posted: 2017-06-08

Locations

1 site across 1 country: United States