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Smoking Cessation Agent

Smoking cessation with varenicline for Tardive Dyskinesia

Phase 4

Recruiting

Led By Stanley N Caroff, MD

Research Sponsored by Corporal Michael J. Crescenz VA Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

Summary

To test the feasibility of studying effects of smoking cessation with varenicline on antipsychotic drug-induced neurological side effects, we propose a 12 week pilot study of smoking cessation treatment with varenicline in 10 schizophrenia or schizoaffective disorder patients who are actively smoking and have pre-existing TD while receiving stable doses of antipsychotics. Subjects will be followed after a 2 week baseline period to assess changes in smoking status and neurological symptoms using standardized rating scales. The aim is to examine clinically significant effects on antipsychotic-induced neurological side effects that may warrant further investigation.

Eligible Conditions

Tardive Dyskinesia
Schizophrenia
Schizoaffective Disorder
Tobacco Smoking
Parkinson's Disease

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Self-reported 7-day point prevalence of abstinence prior to week 12

Secondary study objectives

A reduction in smoking was determined by a >50% reduction in mean number of cigarettes consumption per day at week 12 compared to baseline

Abstinence determined by 24-hour point prevalence at week 12

Abstinence determined by a CO measure cutoff of ≤ 5 ppm

Other study objectives

Mean change in the sum total of score on the AIMS (items 1-7) from the baseline to endpoint visits

Percent of patients showing at least 50% improvement in AIMS score

Percent of subjects showing Clinical Global Impression ratings of at least "much improved"

Side effects data

From 2022 Phase 4 trial • 39 Patients • NCT04011280

50%

Dysgeusia

50%

Anxiety

36%

Sleep Disturbances

29%

Nausea

21%

Agitation

21%

Depression

21%

Headache

14%

Heartburn

14%

Allergies

14%

Cold

14%

Back Pain

Confusion

Aggression

Panic

Stomach Pain

Dizziness

Fatigue

Leg Spasms

Sinusitis

Angina

Increased Blood Pressure

Palpitations

Cellulitis

Rash

Malaise

Weight Gain

Gum Disease

Pharyngitis

Leg Cramps

Muscle Pain

100%

80%

60%

40%

20%

Study treatment Arm

Low Dose Varenicline

Standard Dose Varenicline

Trial Design

1Treatment groups

Experimental Treatment

Group I: Smoking cessation with vareniclineExperimental Treatment1 Intervention

FDA-approved indication of varenicline for smoking cessation

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Varenicline

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Corporal Michael J. Crescenz VA Medical CenterLead Sponsor

30 Previous Clinical Trials

10,037 Total Patients Enrolled

Stanley N Caroff, MDPrincipal InvestigatorCpl. Michael J. Crescenz VA Medical Center

1 Previous Clinical Trials

36 Total Patients Enrolled

1 Trials studying Tardive Dyskinesia

36 Patients Enrolled for Tardive Dyskinesia

~1 spots leftby Sep 2025

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