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- Klinische proef NCT01639560
Varenicline for Light Smokers (ChanLight)
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 4
Contacten en locaties
Studie Locaties
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Minnesota
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Rochester, Minnesota, Verenigde Staten, 55905
- Mayo Clinic
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Subjects must be ≥ 18 years of age;
- smokes 5 to 10 CPD for at least 6 months;
- express interest in quitting smoking;
- indicate ability to complete all study visits; and
- provide written informed consent to participate in the study.
- Subject is a female subject of non-childbearing potential or a female subject of childbearing potential - who is using contraceptives and has a negative pregnancy test result;
- Subject is in good health as determined by the investigator;
- Subject has the ability to participate fully in all aspects of the study and keep scheduled appointments.
Exclusion Criteria:
- An active medical condition such as unstable angina, myocardial infarction, or coronary angioplasty within the past 3 months or an untreated cardiac dysrhythmia;
- History of renal failure;
- Cancer [excluding non-melanoma skin cancer] not in remission;
- Psychosis or bipolar disorder;
- Current unstable or untreated moderate or severe depression as assessed by the CES-D;
- have, as defined by the C-SSRS (Columbia-Suicide Severity Rating Scale), current non-specific suicidal thoughts, or have a lifetime history of a suicidal attempt (defined as "potentially self-injurious act committed with at least some wish to die, as a result of act.");
Substance dependence other than nicotine, defined as:
a. Patient has a recent history (past month) of heavy alcohol consumption as defined by NIAAA: i. Men: More than 4 drinks on any day or 14 per week ii. Women: More than 3 drinks on any day or 7 per week. b. Use of cocaine, heroin, club drugs (i.e., MDMA/"ecstasy"), methamphetamine, or hallucinogens (e.g., LSD) at any time during the past month.
c. Use of marijuana on a weekly basis for the past month
- An allergy to varenicline;
- Current use of a behavioral or pharmacologic tobacco dependence treatment and unwilling or unable to discontinue use;
- Another member of their household already participating in this study; and
- Current treatment with another investigational drug (within 30 days of study entry).
- Has an unstable medical condition;
- Subject has untreated hypertension or baseline systolic blood pressure > 180 or diastolic > 100;
- Women of child-bearing potential, or who are pregnant, lactating or likely to become pregnant during the trial and are unwilling to use an acceptable form of contraception during the medication phase will also be excluded. All female subjects of childbearing potential must have a negative pregnancy test and must agree to use approved contraception during participation in the study.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Actieve vergelijker: Varenicline
1 mg of varenicline twice per day for 12 weeks.
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1 mg of varenicline twice per day for 12 weeks and brief behavioral counseling
Andere namen:
|
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Placebo-vergelijker: placebo
1 placebo tablet twice a day for 12 weeks
|
1 placebo tablet twice per day for 12 weeks and brief behavioral counseling
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Point Prevalence Smoking Outcome at 12 Weeks (End of Treatment)
Tijdsspanne: 12 weeks
|
To determine the efficacy of 12 weeks of varenicline therapy in achieving increased smoking abstinence rates in light smokers.
Point prevalence is defined as no smoking in the past 7 days.
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12 weeks
|
|
Prolonged Smoking Outcome at 12 Weeks (End of Treatment)
Tijdsspanne: 12 weeks
|
To determine the efficacy of 12 weeks of varenicline therapy in achieving increased smoking abstinence rates in light smokers.
Prolonged abstinence is defined as no smoking since 2 weeks after the target quit date.
|
12 weeks
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Point Prevalence Smoking Outcome at 24 Weeks (End of Study)
Tijdsspanne: 24 weeks
|
To determine the efficacy of 12 weeks of varenicline therapy in achieving increased smoking abstinence rates at 6 months in light smokers.
Point prevalence is defined as no smoking in the past 7 days.
|
24 weeks
|
|
Prolonged Smoking Outcome at 24 Weeks (End of Study)
Tijdsspanne: 24 weeks
|
To determine the efficacy of 12 weeks of varenicline therapy in achieving increased smoking abstinence rates at 6 months in light smokers.
Prolonged abstinence is defined as no smoking since 2 weeks after the target quit date.
|
24 weeks
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Ivana T. Croghan, PhD, Mayo Clinic
- Hoofdonderzoeker: Jon O. Ebbert, MD, Mayo Clinic
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 12-005652
- WS2293926 (Ander subsidie-/financieringsnummer: Pfizer Inc)
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