Test of Novel Drug for Smoking Cessation
| Status: | Completed |
|---|---|
| Conditions: | Smoking Cessation |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 8/17/2018 |
| Start Date: | November 2014 |
| End Date: | January 2018 |
Development of a Novel Therapeutic for Smoking Cessation
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.
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.
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.
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.
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.
We found this trial at
1
site
200 Lothrop St
Pittsburgh, Pennsylvania 15213
Pittsburgh, Pennsylvania 15213
Principal Investigator: Kenneth A Perkins, PhD
Phone: 412-246-5397
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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