Depressed Mood Improvement Through Nicotine Dosing 3

PHASE2RecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

April 15, 2023

Primary Completion Date

October 31, 2025

Study Completion Date

September 30, 2026

Conditions
Depressive Disorder
Interventions
DRUG

Transdermal Nicotine Patch

Participants will wear nicotine transdermal patches daily for 12-15 weeks. They will apply a study patch each morning and remove at bedtime. Active dose will titrate up from 3.5mg to 7mg, and then can optionally be further titrated to a maximum dose of 14mg. After week12, the dose will be slowly tapered over 2-3 weeks.

DRUG

Transdermal Placebo Patch

Participants will wear placebo transdermal patches daily for 12-15 weeks. They will apply a study patch each morning and remove at bedtime. Placebo patch dose will titrate up from 3.5mg to 7mg, and then can optionally be further titrated to a maximum dose of 14mg. After week12, the dose will be slowly tapered over 2-3 weeks.

Trial Locations (1)

37212

RECRUITING

Vanderbilt Psychiatric Hosptial, Nashville

All Listed Sponsors
collaborator

National Institute of Mental Health (NIMH)

NIH

lead

Vanderbilt University Medical Center

OTHER