NCT06617312

Examining the Effects of Cytisinicline on Neural Substrates of Cigarette Cue-reactivity

Examining the Effects of Cytisinicline on Neural Substrates of Cigarette Cue-Reactivity

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: University of California, Los Angeles · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study will randomize 64 non-treatment seeking individuals who smoke cigarettes daily in a double-blind, placebo-controlled laboratory study testing the effects of cytisinicline on the neural substrates of cigarette cue reactivity.

Detailed description

The objective of this study is to examine the effects of cytisinicline on neural substrates of cigarette cue-reactivity. We will randomize 64 adults who smoke cigarettes daily (N=32 cytisinicline, N=32 placebo; 50% female) into a double-blind, placebo-controlled laboratory study of cytisinicline. Specifically, participants will complete a 2- to 3-week outpatient protocol that includes taking cytisinicline (3 mg, 3 times daily) or matched placebo (0 mg, 3 times daily) and completing a brief daily diary assessment of cigarette use and craving. Following 2- to 3-weeks of cytisinicline (or placebo) treatment, participants will complete a cigarette cue-exposure task during fMRI. Total study participation will be approximately 4 weeks.

Conditions

• Smoking Cessation
• Tobacco Use Disorder

Interventions

Type	Name	Description
DRUG	Cytisinicline	Targets α4β2 nicotinic acetylcholine receptors
DRUG	Placebo Oral Capsule	Matched to active drug, cytisinicline

Timeline

• Start date: 2024-12-05
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2024-09-27
• Last updated: 2025-12-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study