- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02217527
Test of Novel Drug for Smoking Cessation (UH3-P2)
16 juli 2018 uppdaterad av: Kenneth A. Perkins, PhD., Chengappa, K.N. Roy, MD
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
36
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Pennsylvania
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Pittsburgh, Pennsylvania, Förenta staterna, 15213
- Univ of Pittsburgh Medical Center
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 65 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
Healthy male and female dependent smokers wanting to quit soon
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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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 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.
|
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.
Andra namn:
Placebo pill will be taken daily to assess ability to briefly quit smoking on Mon-Fri for one week.
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Experimentell: Placebo-piller
Placebo-piller användes under en veckas försök att sluta, som en del av crossover-designen.
|
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.
Andra namn:
Placebo pill will be taken daily to assess ability to briefly quit smoking on Mon-Fri for one week.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Quit Status
Tidsram: up to one week each drug phase (0-5)
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Complete abstinence from smoking for 24 hr is counted as a "quit day" and is assessed daily from Mon-Fri for just one week, on the JNJ active drug and one week on placebo.
This same Mon-Fri procedure for one week (only) is done for both drug phases.
Total outcome in each drug condition therefore is number of quit days out of the five assessment days (range 0-5).
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up to one week each drug phase (0-5)
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Minnesota Nicotine Withdrawal Scale (MNWS) During Attempt to Quit on Active JNJ Drug and on Placebo
Tidsram: only on days quit while on JNJ or on placebo
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Severity of withdrawal symptoms will be assessed with standard self-report measure of Minnesota Nicotine Withdrawal Scale (MNWS) each quit day during one week only on active JNJ, and each quit day during one week on placebo.
Ratings are made on 0-100 visual analog scale, with 0="not at all" to 100="very much", and are averaged to create a total score also ranging from 0-100.
Higher scores indicate more severe withdrawal.
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only on days quit while on JNJ or on placebo
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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
Tidsram: first day during quit week on JNJ, and during quit week on placebo.
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This measure of cognitive performance (mean of median speed of correct responding on computer keyboard to letters and numbers) was assessed only on Monday (day 1) of the 0-5 days during each drug/placebo condition.
Data only from those shown to have CO<10 ppm were analyzed, to confirm responding during abstinence while on drug/placebo condition.
Cognitive testing consisted of standard Continuous Performance Task (CPT), on active JNJ and on placebo phases.
This measure is assessed to determine potential mechanism of drug efficacy in relieving disrupted cognitive processing function caused by tobacco deprivation and withdrawal.
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first day during quit week on JNJ, and during quit week on placebo.
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Kenneth Perkins, PhD, Univ of Pittsburgh
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 november 2014
Primärt slutförande (Faktisk)
1 juli 2017
Avslutad studie (Faktisk)
1 januari 2018
Studieregistreringsdatum
Först inskickad
24 juli 2014
Först inskickad som uppfyllde QC-kriterierna
14 augusti 2014
Första postat (Uppskatta)
15 augusti 2014
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
15 augusti 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
16 juli 2018
Senast verifierad
1 juli 2018
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- UH3-PRO14070319
- UH3TR000958 (U.S.S. NIH-anslag/kontrakt)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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