Test of Novel Drug for Smoking Cessation (UH3-P2)
16. juli 2018 oppdatert 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
36
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, Forente stater, 15213
- Univ of Pittsburgh Medical Center
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
Andre navn:
Placebo pill will be taken daily to assess ability to briefly quit smoking on Mon-Fri for one week.
|
|
Eksperimentell: Placebo pille
Placebo-pille brukt i en ukes forsøk på å slutte, som en del av crossover-designet.
|
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.
Andre navn:
Placebo pill will be taken daily to assess ability to briefly quit smoking on Mon-Fri for one week.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Quit Status
Tidsramme: up to one week each drug phase (0-5)
|
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).
|
up to one week each drug phase (0-5)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Minnesota Nicotine Withdrawal Scale (MNWS) During Attempt to Quit on Active JNJ Drug and on Placebo
Tidsramme: only on days quit while on JNJ or on placebo
|
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.
|
only on days quit while on JNJ or on placebo
|
|
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
Tidsramme: first day during quit week on JNJ, and during quit week on placebo.
|
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.
|
first day during quit week on JNJ, and during quit week on placebo.
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Kenneth Perkins, PhD, Univ of Pittsburgh
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. november 2014
Primær fullføring (Faktiske)
1. juli 2017
Studiet fullført (Faktiske)
1. januar 2018
Datoer for studieregistrering
Først innsendt
24. juli 2014
Først innsendt som oppfylte QC-kriteriene
14. august 2014
Først lagt ut (Anslag)
15. august 2014
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
15. august 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
16. juli 2018
Sist bekreftet
1. juli 2018
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- UH3-PRO14070319
- UH3TR000958 (U.S. NIH-stipend/kontrakt)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .