NCT02432066

Effects of GTS-21 on Smoking Behavior and Neurocognitive Functions

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 25 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Attempts to quit cigarette smoking are often accompanied by negative mood and problems in attention and memory. These effects, in turn, may contribute to smoking relapse. This exploratory/developmental project examines the effects of a novel medication, GTS-21, on individuals interested in smoking cessation. It is hypothesized that GTS-21 will reduce negative affect, improve cognition and/or reduce smoking relapse in healthy adult men and women who are chronic cigarette smokers.

Detailed description

The project is a clinical trial assessing the effects of GTS-21 (an α7 nicotinic receptor partial agonist) on smoking, mood, neurocognition, and neurophysiology, in a small sample of chronic smokers who are currently healthy and interested in smoking cessation. Using a double-blind, placebo controlled, parallel group design, 54 (27 women) community smokers who have demonstrated a readiness to quit will participate over a 7 week active trial. Subjects will be randomly assigned to active drug or placebo groups. Across the study period, participants will undergo repeated neurobehavioral testing, laboratory assessments of cardiovascular and liver function, and provide weekly updates regarding smoking behavior, mood state and side-effects.

Conditions

• Tobacco Use Disorder

Interventions

Type	Name	Description
DRUG	GTS-21	GTS-21 is a partial alpha7 nicotinic agonist. GTS-21 will be compounded by the UF investigational pharmacy, and administered orally.
DRUG	Placebo	Oral placebo pills, compounded by the UF investigational pharmacy

Timeline

• Start date: 2018-09-29
• Primary completion: 2018-12-29
• Completion: 2020-12-29
• First posted: 2015-05-01
• Last updated: 2019-03-25

Regulatory

• FDA-regulated drug study