Status:
COMPLETED
Test of Novel Drug for Smoking Cessation
Lead Sponsor:
Chengappa, K.N. Roy, MD
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Smoking Cessation
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The study will assess a novel active drug vs. placebo on ability to reduce smoking and aid cessation during a one-week "practice" quit period for each condition in smokers with a high interest in quit...
Detailed Description
We aim to test the proof of principal that an alpha-7 PAM drug, JNJ-39393406, promotes smoking cessation when compared to placebo. We have developed, tested, and validated an efficient Phase 2a screen...
Eligibility Criteria
Inclusion
- Healthy male and female dependent smokers wanting to quit soon
- \-
Exclusion
- Use of non-smoked nicotine products
- Already enrolled in cessation program.
- Recent alcohol or substance dependence (≤ 3 months)
- Women who are pregnant, planning a pregnancy, or lactating; all female participants shall undergo a pregnancy test at screening and will be excluded if positive.
- Serious or unstable medical disorder within the past 3 months
- Epilepsy
- Current diagnosis (within last 6-months) of abnormal cardiac rhythms; unstable cardiovascular disease e.g. stroke, myocardial infarction in the last 6 months
- Evidence impaired liver function test (LFT)
- Evidence of kidney failure
- Any subject with a history of hematological cancers examples: leukemia, lymphoma etc.
- Any clinically significant hematological laboratory abnormality.
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2018
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT02217527
Start Date
November 1 2014
End Date
January 1 2018
Last Update
August 15 2018
Active Locations (1)
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1
Univ of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213