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Development of a Novel Therapeutic for Smoking Cessation (UH3-P2)
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.
Details
| Lead sponsor | Chengappa, K.N. Roy, MD |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 36 |
| Start date | 2014-11 |
| Completion | 2018-01 |
Conditions
- Smoking Cessation
Interventions
- Active JNJ Drug
- Placebo pill
Primary outcomes
- Quit Status — up to one week each drug phase (0-5)
Complete abstinence from smoking for 24 hr is counted as a "quit day" and is assessed daily from Mon-Fri for just one week, on the JNJ active drug and one week on placebo. This same Mon-Fri procedure for one week (only) is done for both drug phases. Total outcome in each drug condition therefore is number of quit days out of the five assessment days (range 0-5).
Countries
United States