Clinical trial NCT02217527: Test of Novel Drug for Smoking Cessation
Official title: Development of a Novel Therapeutic for Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Smoking Cessation
Keywords: crossover
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2014-08-15
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover of active JNJ vs. placebo for 2 weeks each, involving 1 week of dose run-up and 1 week of attempting to quit each day on that drug condition. A one-week washout separates these drug conditions, which are administered in counter-balanced order.
Primary purpose: BASIC_SCIENCE

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 quitting (i.e. crossover design). Medication effects on reducing withdrawal and cognitive impairment will help assess the mechanism to support quit smoking attempts.

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 screening procedure that optimally combines the validity of randomized clinical trials with the practicality of lab- based medication studies. Notably, it employs a within-subject, cross-over design comparing active versus placebo effects on quitting smoking to maximize statistical power without a large sample, in contrast to the large samples needed for between-groups randomized treatment conditions. Using this procedure, we will evaluate effects of JNJ-39393406 vs. placebo on short-term smoking abstinence in smokers who already have a high interest in quitting soon. We predict that, compared with placebo, JNJ-39393406 will increase days of abstinence, identifying initial evidence of efficacy for smoking cessation. Our main dependent measure is days of very stringent biochemically validated (expired CO\<5 ppm) 24-hr smoking abstinence, with post-quit withdrawal and cognitive function as secondary measures. Potential for adverse side-effects will be assessed at each visit.

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.

Primary outcomes:
measure: Quit Status
timeFrame: up to one week each drug phase (0-5)
Secondary outcomes:
measure: Minnesota Nicotine Withdrawal Scale (MNWS) During Attempt to Quit on Active JNJ Drug and on Placebo
timeFrame: only on days quit while on JNJ or on placebo
measure: 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
timeFrame: first day during quit week on JNJ, and during quit week on placebo.
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Univ of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: Univ of PIttsburgh
name: Kenneth Perkins, PhD
role: PRINCIPAL_INVESTIGATOR
References: