Test of Novel Drug for Smoking Cessation (UH3-P2)

Chengappa, K.N. Roy, MD

Status and phase: Completed; Phase 2

Conditions: Smoking Cessation

Treatments: Drug: Active JNJ Drug; Drug: Placebo pill

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02217527

UH3-PRO14070319

UH3TR000958 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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36 participants in 2 patient groups

JNJ Active Drug

Experimental group

Description:

200 mg (100 mg b.i.d.) Active JNJ Drug used to assess quitting for one week, as part of crossover design. This JNJ experimental compound has NO name, just a company number.

Treatment:

Drug: Active JNJ Drug

Drug: Placebo pill

Placebo Pill

Experimental group

Description:

Placebo pill used for one week quit attempt, as part of crossover design.

Treatment:

Drug: Active JNJ Drug

Drug: Placebo pill