Smoking Cessation With Varenicline in Schizophrenia: Antipsychotic-Induced Neurological Symptoms as Correlates

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Corporal Michael J. Crescenz VA Medical Center
Study ID
NCT03495024
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Varenicline — DRUG
    Oral medication approved to facilitate smoking cessation

Study Details

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.

Key Dates

Start date
Jan 1, 2019
Status verified
Mar 2019
Primary completion
Apr 30, 2020
Completion
Jun 30, 2020

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Smoking cessation with varenicline
    FDA-approved indication of varenicline for smoking cessation

Primary Outcome Measure

Self-reported 7-day point prevalence of abstinence prior to week 12 [ Time Frame: 12 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Corporal Michael J Crescenz VA Medical CenterPhiladelphiaPennsylvania19104
Stanley N Caroff, MD
[email protected]
215-823-4065
Rosalind M Berkowitz, MD
[email protected]
215-823-4065

Find similar trials in Philadelphia, PA

By condition
Schizophrenia
By specialty
PsychiatryMental healthBehavioral health
By research site
Corporal Michael J Crescenz VA Medical Center· Philadelphia, PA

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