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Smoking Cessation Agent
Smoking Cessation With Varenicline in Schizophrenia: Antipsychotic-Induced Neurological Symptoms as Correlates
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
No Placebo-Only Group
Drug Has Already Been Approved
Pivotal Trial
All Individual Drugs Already Approved
Approved for 5 Other Conditions
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
- Parkinson's disease
- Schizoaffective Disorder
- Tobacco Smoking
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
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 • NCT0401128050%
Dysgeusia
50%
Anxiety
36%
Sleep Disturbances
29%
Nausea
21%
Agitation
21%
Depression
21%
Headache
14%
Heartburn
14%
Allergies
14%
Cold
14%
Back Pain
7%
Confusion
7%
Aggression
7%
Panic
7%
Stomach Pain
7%
Dizziness
7%
Fatigue
7%
Leg Spasms
7%
Sinusitis
7%
Angina
7%
Increased Blood Pressure
7%
Palpitations
7%
Cellulitis
7%
Rash
7%
Malaise
7%
Weight Gain
7%
Gum Disease
7%
Pharyngitis
7%
Leg Cramps
7%
Muscle Pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Low Dose Varenicline
Standard Dose Varenicline
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
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
Find a Location
Who is running the clinical trial?
Corporal Michael J. Crescenz VA Medical CenterLead Sponsor
30 Previous Clinical Trials
9,887 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