Status:
COMPLETED
Novel Smoking Cessation Drug for Schizophrenia
Lead Sponsor:
K.N. Roy Chengappa
Collaborating Sponsors:
University of Pittsburgh
National Institutes of Health (NIH)
Conditions:
Smoking Cessation
Eligibility:
All Genders
18-66 years
Phase:
PHASE2
Brief Summary
The investigators will evaluate effects of a novel drug that improves nicotinergic receptor function vs. placebo on short-term smoking abstinence in smokers with schizophrenia who have a high interest...
Detailed Description
Objective: This is a Proof of Concept study planned over nearly 2 years to determine the potential efficacy of a novel drug for smokers with schizophrenia. This study will assess 60 smokers with a d...
Eligibility Criteria
Inclusion
- List the specific criteria for inclusion of potential subjects.
- Men or women of any race, ages 18 to 65 years, (≥18 years, ≤ 66 years)
- Willing to provide written informed consent
- MINI (Sheehan et al 1998, 2008) chart and/or clinician consensus affirmed DSM IV TR or (DSM -V) diagnoses of schizophrenia or schizoaffective disorder.
- Patients whose PANSS total scores have been stable for ≥ 4 weeks (clinician and/or subject affirmed) and at ≤ 70
- No recent ( ≤ 3months) hospitalization, aggression, or suicidal attempts
- Stable doses of antipsychotic medication, ≥ 4 weeks
- Smoking
- Smoke ≥ 5 cigarettes/day
- Smoking cigarettes ≥ 1 year
Exclusion
- Smoking/Nicotine Exclusions:
- Use of smokeless tobacco or snuff or chewing tobacco
- Use of e-cigarettes, or any non-tobacco nicotine products (e.g. nicotine gum, lozenges, patch, etc.)
- Current enrollment or plans to enroll in another smoking cessation program. (Bupropion use for depression will be assessed on a case by case basis)
- Alcohol/Illicit Substance
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 9 2017
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT02230384
Start Date
September 1 2014
End Date
March 9 2017
Last Update
April 2 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Western Psychiatric Institute and Clinic and affilated sites
Pittsburgh, Pennsylvania, United States, 15213