CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 38 enrolled
Drug / intervention
Nicotine patch +3 moredrug
Likely dose
Nicotine lozenge 4 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03822416
NCT03822416Phase 2Completed

Treating Tobacco Dependence in Smokers With Severe Mental Illness

University of Minnesota·interventional·Posted Jan 30, 2019·Updated May 25, 2021

In Brief

A Phase 2 clinical trial evaluating Nicotine patch, Nicotine lozenge, and 2 other interventions for Smoking Cessation and 7 related conditions. Completed, enrolled 38 participants across 1 site.

Detailed Summary

This is a smoking cessation study that will enroll smokers who have been diagnosed with a severe mental illness. The study will use a combination of intensive tobacco treatment counseling and nicotine replacement therapy to assist smokers in cutting back on and quitting smoking over the course of six months.

Study Details

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedJan 30, 2019
Enrollment StartMar 1, 2019
Primary CompletionMay 4, 2020
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 7.4 years ago

Interventions

Nicotine patchdrug

Nicotine patch (dose based on number of cigarettes per day) (4-week, 8-week, or 12-week supply) depending on participant preference and how much they are smoking based on FDA guidelines for use

Nicotine lozengedrug

Nicotine lozenge (2 or 4 mg if less or greater than 30 minutes to first cigarette in the morning respectively) (4-week, 8-week, or 12-week supply) depending on participant preference and how much they are smoking based on FDA guidelines for use

Therapybehavioral

In-person meeting at baseline, 6 phone counseling sessions with participants over 8 weeks after initial in-person meeting, possible additional phone counseling (3 phone calls) from 8 weeks to 6 months after initial in-person meeting, and possible text messages when agreed to by participants during the 8 week to 6 month phase

Informationother

Information about smoking and mental illness and referrals to both the QUITPLAN helpline and additional resources in the community