Smoking Cessation Study In Healthy Adolescent Smokers

Smoking Cessation Clinical Trial

Official title:

A Twelve-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-ranging Study With Follow-up Evaluating The Safety And Efficacy Of Varenicline For Smoking Cessation In Healthy Adolescent Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01312909
• Other study ID #: A3051073
• Secondary ID: CHANTIX
• Status: Completed
• Phase: Phase 4
• Start date: April 2011
• Est. completion date: January 2018

Study information

• Verified date: July 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is designed to see if varenicline combined with age appropriate (adolescent) smoking cessation counseling will help teens quit smoking.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 312
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 19 Years

Eligibility

Inclusion Criteria:

• Healthy male and female subjects between the ages of 12 and 19, inclusive.

• Subjects smoking at least an average of 5 cigarettes per day, motivated to stop smoking,

• Subjects must have at least one prior failed attempt to quit smoking.

Exclusion Criteria:

• Subjects with history, current diagnosis, or treatment of major depression disorder, anxiety disorders, panic disorder, hostility or aggression disorder, perceptual/thinking disturbances, mania, psychosis, bipolar disorder, personality disorder, eating disorder or severe emotional problems (in the past year).

• Subjects with a prior suicide attempt: subjects hospitalized within the past 12 months due to suicidal ideation or suicidal behavior; subjects considered to have serious suicidal ideation or suicidal behavior in the past 12 months; active suicidal ideation or behavior identified at the screening or baseline visit.

• Evidence of alcohol and substance abuse/dependence (other than nicotine) within 3 months prior to screening.

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Drug:
• Varenicline 1mg BID
Oral Varenicline 1mg BID, or 1/2 that dose (0.5mg BID) for those subjects that weigh less than or equal to 55kg at baseline, for twelve weeks, follow-up through Week 52
• Varenicline 0.5mg BID
Oral Varenicline 0.5mg BID, or 1/2 that dose (0.5 QD) for those subjects that weigh less than or equal to 55kg at baseline, for twelve weeks, follow-up through Week 52
• Placebo
Oral placebo for twelve weeks,follow-up through Week 52

Locations

Country	Name	City	State
Canada	Kids Clinic	Ajax	Ontario
Canada	SKDS Research Inc.	New Market	Ontario
Canada	Private Practice of Robert J. Camargo	Newmarket	Ontario
Georgia	LTD" Rustavi Psychological Health Center"	Rustavi
Korea, Republic of	Hallym University Sacred Heart Hospital	Anyang-si	Gyeonggi-do
Korea, Republic of	Keimyung University Dongsan Hospital	Daegu
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do
Korea, Republic of	The Catholic University of Korea St. Vincent Hospital	Suwon-si	Gyeonggi-do
Russian Federation	GBUZ City childrens out-patient clinic # 10 of Moscow	Moscow
Russian Federation	GOBUZ Murmansk Regional Narcology Dispensary	Murmansk
Russian Federation	LLC City Neurological Center "Sibneuromed"	Novosibirsk
Russian Federation	First St. Petersburg State Medical University	Saint-Petersburg
Russian Federation	FSBI V.M.Bekhterev National Research Medical Center for Psychiatry and Neurology of RF MoH	Saint-Petersburg
Russian Federation	LLC " Alliance Biomedical - Russian Group"	Saint-Petersburg
Russian Federation	LLC Medical Technologies	Saint-Petersburg
Russian Federation	LLC Medical Technologies	Saint-Petersburg
Russian Federation	GBUZ Samara Regional Childrens Health camp Yunost	Samara
Russian Federation	Leningrad Regional Dispensary of Narcology	Village Novoe Devyatkino	Leningrad Region
Taiwan	Kaohsiung Veterans General Hospital	Kaohsiung City
Taiwan	Far Eastern Memorial Hospital	New Taipei City
Taiwan	Taipei Medical University Shuang Ho Hospital	New Taipei City
Taiwan	China Medical University Hospital	Taichung city
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	Taipei Veterans General Hospital	Taipei City
United States	Anaheim Clinical Trials, LLC	Anaheim	California
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado
United States	Kentucky Pediatric/Adult Research	Bardstown	Kentucky
United States	Neuro-Behavioral Clinical Research, Inc.	Canton	Ohio
United States	Medical University of South Carolina	Charleston	South Carolina
United States	MCB Clinical Research Centers	Colorado Springs	Colorado
United States	FutureSearch Trials of Dallas, L.P.	Dallas	Texas
United States	Avail Clinical Research, LLC	DeLand	Florida
United States	Western Affiliated Research Institute	Denver	Colorado
United States	Insite Clinical Research, LLC	DeSoto	Texas
United States	Midwest Behavioral Health	Evansville	Indiana
United States	Dedicated Clinical Research	Goodyear	Arizona
United States	Goldpoint Clinical Research, LLC	Indianapolis	Indiana
United States	The Center for Pharmaceutical Research, P.C.	Kansas City	Missouri
United States	Eastside Therapeutic Resource	Kirkland	Washington
United States	Hope Clinical Research	Kissimmee	Florida
United States	Omega Clinical Trials, LLC	La Habra	California
United States	R/D Clinical Research, Inc.	Lake Jackson	Texas
United States	Central Kentucky Research Associates, Inc.	Lexington	Kentucky
United States	Premier Psychiatric Research Institute, LLC	Lincoln	Nebraska
United States	Arkansas Psychiatric Clinic Clinical Research Trials, P.A.	Little Rock	Arkansas
United States	Florida Clinical Research Center, LLC	Maitland	Florida
United States	Barney Greenspan, Ph.D	Meridian	Idaho
United States	Solaris Clinical Research	Meridian	Idaho
United States	L & L Research Choices	Miami	Florida
United States	Pharmax Research Clinic, Inc.	Miami	Florida
United States	Dean Foundation for Health Research and Education	Middleton	Wisconsin
United States	Coastal Carolina Research Center	Mount Pleasant	South Carolina
United States	Synergy Clinical Research Center	National City	California
United States	Connecticut Mental Health Center	New Haven	Connecticut
United States	Yale University	New Haven	Connecticut
United States	Yale University, SATU	New Haven	Connecticut
United States	Louisiana Research Associates, Inc	New Orleans	Louisiana
United States	Pedia Research, LLC	Newburgh	Indiana
United States	Bravo Health Care Center	North Bay Village	Florida
United States	Psychiatric Care & Research Center	O'Fallon	Missouri
United States	Pacific Research Partners, LLC	Oakland	California
United States	North County Clinical Research	Oceanside	California
United States	Cutting Edge Research Group	Oklahoma City	Oklahoma
United States	Medical Research Group of Central Florida	Orange City	Florida
United States	Pedia Research, LLC	Owensboro	Kentucky
United States	Research Integrity, LLC	Owensboro	Kentucky
United States	IICR, Inc. (DBA: International Institute of Clinical Research)	Ozark	Alabama
United States	Wake Internal Medicine Consultants, Inc	Raleigh	North Carolina
United States	Wake Research Associates	Raleigh	North Carolina
United States	Zain Research, LLC	Richland	Washington
United States	Clinical Research Partners, LLC	Richmond	Virginia
United States	Rochester Center for Behavioral Medicine	Rochester Hills	Michigan
United States	Mid-America Clinical Research, LLC	Saint Louis	Missouri
United States	Comprehensive Clinical Development Inc.	Saint Petersburg	Florida
United States	Clinical Trials of Texas, Inc.	San Antonio	Texas
United States	Thomas Murray DeMoor, MD	San Antonio	Texas
United States	Neurology & Neuroscience Center of Ohio	Toledo	Ohio
United States	Adams Clinical Trials, LLC	Watertown	Massachusetts
United States	Heartland Research Associates, LLC	Wichita	Kansas
United States	PMG Research of Wilmington, LLC	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Canada,  Georgia,  Korea, Republic of,  Russian Federation,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants With Treatment-Emergent Adverse Events (AEs)	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both non-serious AEs and SAEs.	First dose up to last dose (up-to Week 12) plus 30 days
Other	Number of Participants With Treatment Emergent Treatment-Related Adverse Events (AEs)	Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent were events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to drug Varenicline was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category. An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both non-serious AEs and SAEs.	First dose up to last dose (up-to Week 12) plus 30 days
Other	Number of Participants With Treatment-Emergent Neuropsychiatric Adverse Event Elicited by Neuropsychiatric Adverse Event Interview (NAEI)	An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE: AE causing: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent/significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug and up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Solicited AEs collected by semi-structured NAEI inquiring about AEs: depression, anxiety, delusions, hallucinations, paranoia, psychosis, mania, panic, agitation, dissociative states, feeling abnormal, hostility, aggression and homicidal ideation. If a participant had a positive response to any item on the NAEI, investigator determined if it met criteria AE criteria.	First dose up to last dose (up-to Week 12) plus 30 days
Other	Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)	The C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) categories);was an interview-based instrument to systematically assess suicidal ideation and suicidal behavior.C-SSRS assessed whether participant experienced any of the following:completed suicide;suicide attempt(response of "Yes" on "actual attempt");preparatory acts toward imminent suicidal behavior ("Yes" on "preparatory acts or behavior","aborted attempt" or "interrupted attempt"),suicidal ideation ("Yes" on "wish to be dead","non-specific active suicidal thoughts","active suicidal ideation with methods without intent to act or some intent to act,without specific plan or with specific plan and intent,any self-injurious behavior with no suicidal intent ("Yes" on "Has participant engaged in non-suicidal self-injurious behavior").Here,number of participants with positive response (response of "yes") to suicidal behavior or/and Ideation,any non-suicidal self-injurious behavior were reported.	Screening, Baseline, Week 1 up to Week 12 (treatment-emergent [TE]), thereafter up to Week 52 (last follow-up [FU])
Other	Change From Baseline in Hospital Anxiety and Depression Scale (HADS) - Anxiety (HADS-A) Total Scores at Specified Time-points	The HADS is a self-administered questionnaire measuring anxiety. Hospital Anxiety and Depression Scale Anxiety subscale (HADS-A) consisted of 7 items that were assessed on a scale of 0 = no anxiety to 3 = severe feeling of anxiety. Total HADS-A subscale score range from 0 = no anxiety to 21 = severe anxiety; higher scores indicated more severe anxiety.	Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 20, 28, 36, 44, and 52
Other	Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Scores - Depression Total Score at Specified Time-Points	Hospital Anxiety and Depression Scale Depression subscale (HADS-D) consists of 7 items that were assessed on a scale of 0 = no depression to 3 = severe feeling of depression. Total HADS-D subscale score range from 0 = no depression to 21 = severe feeling of depression; higher scores indicated a greater intensity of depression.	Baseline, Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 20, 28, 36, 44, and 52
Other	Number of Participants With Laboratory Abnormalities	Criteria for laboratory abnormalities: Lymphocytes Absolute (Abs), Lymphocytes percentage (%), Total Neutrophils (Abs), Neutrophils %: <0.8*LLN or >1.2*ULN; Basophils (Abs), Basophils %Eosinophils (Abs), Eosinophils %, Monocytes (Abs), Monocytes %:> 1.2*ULN; Total Bilirubin milligram per deciliter (mg/dl) >1.5*ULN; alanine aminotransferase: >3.0*ULN; Blood urea nitrogen, Creatinine: >1.3*ULN; Uric acid :> 1.2*ULN.	Baseline up to Week 12
Other	Change From Baseline in Blood Pressure (BP) at Week 12	Measurement of BP included supine and sitting systolic BP, standing systolic BP, supine and sitting diastolic BP and standing diastolic BP. Blood pressure was taken after participants rested in a sitting position for 5 minutes. BP was recorded after participants had been supine for approximately 5 minutes, and then orthostatic blood pressure was recorded immediately when the participant stood.	Baseline, Week 12
Other	Change From Baseline in Pulse Rate at Week 12	Measurement of pulse rate included supine, sitting and standing pulse rate. Pulse rate was taken after participants rested in a sitting position for 5 minutes. Pulse rate was recorded after participants had been supine for approximately 5 minutes and then immediately upon standing.	Baseline, Week 12
Primary	4-Week Continuous Abstinence Rate: Percentage of Participants Who Remained Abstinent From Week 9 Through Week 12	The percentage of participants who, at each visit from Week 9 through Week 12, reported no smoking and no use of other nicotine-containing products since the last study visit (on the Nicotine Use Inventory) and at each of these visits were confirmed to have quit based on urine cotinine less than 200 nanograms/milliliter (ng/mL).	Week 9 through Week 12
Secondary	Percentage of Participants With 7-Day Point Prevalence of Smoking Abstinence at Weeks 12, 24 and 52	The percentage of participants who reported no smoking and no use of other nicotine-containing products (treatment phase) or tobacco products (non-treatment phase) on the Nicotine Use Inventory in the 7 days prior to the study visits or telephone contacts at Week 12,24 and 52.	Weeks 12, 24 and 52
Secondary	Daily Number of Cigarettes Smoked at Baseline	The average number of cigarettes smoked per day in the past 7 days reported at the baseline visit.	Baseline
Secondary	Change From Baseline in Daily Number of Cigarettes Smoked at Weeks 12, 24, and 52	The reduction in the number of the cigarettes smoked was calculated by subtracting the reported average number of cigarettes smoked per day in the past 7 days at Weeks 12, 24 and 52 from the average number of cigarettes smoked per day in the past 7 days reported at the baseline visit.	Baseline, Weeks 12, 24, and 52
Secondary	Continuous Abstinence Rate: Percentage of Participants Who Remained Abstinent From Week 9 Through Week 24 and Week 52	The percentage of participants who, at each visit from Week 9 to 52 (inclusive), reported no smoking and no use of other nicotine-containing products (Weeks 9-12) or tobacco products (Weeks 13-52) since the last study visit/last contact (on the Nicotine Use Inventory) and at any of the study visits were confirmed to have quit based on urine cotinine less than 200 ng/mL.	Week 9 through Week 24; Week 9 through Week 52

External Links

•   To obtain contact information for a study center near you, click here.