Test of Novel Drug for Smoking Cessation

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2018-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Smoking Cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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JNJ Active Drug

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.

Group Type EXPERIMENTAL

Active JNJ Drug

Intervention Type DRUG

200 mg/day (100 mg b.i.d.) of Active JNJ Drug will be used for one week while attempting to briefly quit smoking on Mon-Fri of that week.

Placebo pill

Intervention Type DRUG

Placebo pill will be taken daily to assess ability to briefly quit smoking on Mon-Fri for one week.

Placebo Pill

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

Group Type EXPERIMENTAL

Active JNJ Drug

Intervention Type DRUG

200 mg/day (100 mg b.i.d.) of Active JNJ Drug will be used for one week while attempting to briefly quit smoking on Mon-Fri of that week.

Placebo pill

Intervention Type DRUG

Placebo pill will be taken daily to assess ability to briefly quit smoking on Mon-Fri for one week.

Interventions

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Active JNJ Drug

200 mg/day (100 mg b.i.d.) of Active JNJ Drug will be used for one week while attempting to briefly quit smoking on Mon-Fri of that week.

Intervention Type DRUG

Placebo pill

Placebo pill will be taken daily to assess ability to briefly quit smoking on Mon-Fri for one week.

Intervention Type DRUG

Other Intervention Names

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JNJ-39393406

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes