Test of Novel Drug for Smoking Cessation
Completed · Phase 2 · Has a placebo group
Conditions studied: Smoking Cessation
In brief
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 quitting (i.e. crossover design). Medication effects on reducing withdrawal and cognitive impairment will help assess the mechanism to support quit smoking attempts.
Key facts
- Study ID
- NCT02217527
- Run by
- Chengappa, K.N. Roy, MD
- People needed
- 36
- Starts
- 2014-11-01
- Expected to finish
- 2018-01-01
- Last updated by the study team
- 2018-08-15
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Healthy male and female dependent smokers wanting to quit soon
You may not qualify if…
- 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.
Where it is running
- Univ of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
Full record on ClinicalTrials.gov
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