Phase 2
Completed N=36
Test of Novel Drug for Smoking Cessation
Source: ClinicalTrials.gov NCT02217527 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcomePrimary: Quit Status — 0.5; 0.2; 0.7; 0.5 number of days quit
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 quitting (i.e. crossover design). Medication effects on reducing withdrawal and cognitive impairment will help assess the mechanism to support quit smoking attempts.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Quit Status |
0.5; 0.2; 0.7; 0.5 | — |
| SECONDARY Minnesota Nicotine Withdrawal Scale (MNWS) During Attempt to Quit on Active JNJ Drug and on Placebo |
12.4; 24.0; 15.5; 23.1 | — |
| SECONDARY Cognitive Function on Continuous Performance Task (CPT) for Those With CO<10 During First Assessment Day (Mon) of Attempt to Quit Smoking During Both JNJ and Plac Quit Periods |
444.3; 443.3; 434.2; 439.2 | — |
Eligibility Criteria
Inclusion Criteria
Healthy male and female dependent smokers wanting to quit soon
-
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02217527). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.