MDACC Study Summary 2008-0540

Study Summary
No. 2008-0540:.......Cancer Prevention......Maher Karam-Hage......Behavioral Science

Study Summary Title



Study Summary Number:	2008-0540

Study Title:	Phase IV, Prospective, Multi-National, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Smoking Cessation with Varenicline Tartrate Compared with Placebo in the Setting of Patient Self-Selected (Flexible) Quit Date

Physician

New Patient Referral



Name:	Maher Karam-Hage	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Behavioral Science	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-0919 Contact us about clinical trials

General Information



Disease Group:	Cancer Prevention	Supported By:	Pfizer

Phase of Study:	Phase IV	Return Visit:	There are 21 total visits; 18 of which require the patient to come to MDACC. For the first 14 weeks, patients are required to return to the clinic on a weekly basis. The remaining in-person visits are spaced by a 3 - 4 week time interval.

Treatment Agents:	Placebo Varenicline	Home Care:	Patients will be provided medications during clinic visits that they will need to take while in the home environment in order to be compliant with study requirements. They will also receive 3 in-home telephone counseling calls.

Treatment Loc:	Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions

Estimated Length of Stay in Houston:	This is an outpatient only study.


Description/ Intervention:	The goal of this clinical research study is learn if Chantix (varenicline) can help smokers to quit smoking. Researchers also want to learn if allowing smokers to pick their own date to quit, rather than the doctor giving a quit date, will help smokers to be more successful in quitting smoking and staying smoke-free.

Study Objectives / Outcomes

The primary efficacy objective of this protocol is to compare 12 weeks of treatment with varenicline 1 mg BID to placebo for smoking cessation in the setting of a patient self-selected quit date (before Week 5 visit), to evaluate continuous abstinence from smoking for 12 weeks after the treatment period. The additional secondary objectives of comparing treatments for urge to smoke, smoking satisfaction, and the psychological reward over time will be accomplished by analyses of the results from the Minnesota Nicotine Withdrawal Scale (MNWS), and the Modified Cigarette Evaluation Questionnaire (mCEQ), respectively. The safety objective is to gather safety data for 12 weeks of treatment with varenicline 1 mg BID or placebo followed by 12 weeks of non-treatment follow -up, and to evaluate safety and tolerability when used in the setting of a subject self-selected quit date.

The primary efficacy endpoint is the 4-week continuous abstinence rate (CAR) for weeks 9 - 12 (i.e., the proportion of subjects who are able to maintain complete abstinence from cigarette smoking and other nicotine use, with end-expiratory exhaled CO measurements of less than or equal to 10 ppm, for the planned last 4 weeks of treatment).

The key secondary efficacy endpoint is continuous abstinence (CA) from smoking from Week 9 through Week 24 (i.e., the proportion of subjects who are able to maintain complete abstinence from cigarette smoking for Weeks 9 through 24).

Additional secondary efficacy endpoints are long-term quit rate (LTQR) through Week 24 (defined as the proportion of subjects who have successfully quit during the treatment phase of the study based on the 4-week CAR from Week 9 through Week 12 and who have had no more than 6 days of smoking during the non-treatment phase of the study), 7-day point prevalence of nonsmoking at Weeks 12 and 24 (defined as the proportion of subjects who are able to maintain complete abstinence from cigarette smoking for the 7 days prior to Week 12 and Week 24, respectively) and 4-week point prevalence of nonsmoking at Week 24 (defined as the proportion of subjects who are able to maintain complete abstinence from cigarette smoking for the 4-weeks prior to Week 24).

Other efficacy related endpoints are change in Fagerstrom Test for Nicotine Dependence (FTND) from baseline to day of first quit attempt, change in number of cigarettes smoked daily before the first quite attempt, change in urine cotinine before the first quit attempt, and time to first quit attempt.

Study Status Information



Study Activation / Registration Date:	01/28/2009

IRB Review and Approval Date:	11/05/2008

Study Type:	Other

Recruitment Status:	Open

Projected Accrual:	652

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Current cigarette smokers, male or female, who are between the ages of 18 and 75 years, inclusive, and who are motivated to stop smoking.

2) Subjects must have smoked an average of at least 10 cigarettes per day during the past year and during the month prior to the screening visit, with no continuous period of abstinence greater than 3 months in the past year.

3) Females who are not of childbearing potential (i.e., who are surgically sterilized or at least 2 years postmenopausal) and who are not nursing.

4) Females of childbearing potential may be included provided that they are not pregnant, not nursing, agree to avoid pregnancy through 30 days after the last dose of study medication, have a negative serum pregnancy test, and agree to use a medically acceptable birth control method.

5) Subjects must have no serious or unstable disease within the past 6 months.

6) Subjects must be outpatients, assessed in a clinic setting, and be able and willing to comply with all study visits, treatment plan, laboratory tests, and other trial procedures during the treatment and non-treatment phases.

7) Subjects must provide a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the trial.

8) Only one subject per household may participate.

Exclusion Criteria:

1) Subjects currently suffering with depression, or who have been diagnosed with depression or treated with an anti-depressant for their depression within the past 12 months, as indicated by a score of higher than 5 on the PHQ, or a score of greater than 0 on item 9 regarding suicidal ideation or behavior.

2) Subjects with any history of suicidal ideation or suicidal behavior as assessed by the Columbia Suicide-Severity Rating Scale (C-SSRS-Baseline Version) in the past 5 years, or at the time of the Baseline Visit.

3) Subjects with a past or present history of psychosis; subjects with panic attacks or anxiety disorders, or bipolar disorder.

4) Subjects with known severe chronic obstructive pulmonary disease (COPD).

5) Subjects with clinically unstable cardiovascular disease in the past 6 months.

6) Subjects with systolic blood pressure greater than 150 mmHg or a diastolic blood pressure greater than 95 mmHG at screening or baseline.

7) Subjects with clinically significant neurological disorders or cerebrovascular diseases.

8) Subjects with a history of clinically significant or unstable endocrine disorders or gastrointestinal diseases, including insulin dependent diabetes, Type 2 diabetes mellitus with HGA1C greater than 9, uncontrolled hyperthyroidism, and active peptic ulcer.

9) Subjects with clinically significant hepatic impairment [AST or ALT greater than 1.5 times the ULN or total bilirubin greater than 1.1 times ULN] or renal impairment [estimated creatinine clearance by Cockcroft-Gault equaltion less than 30 ml/min) or other clinically significant abnormal laboratory tests.

10) Subjects with a history of cancer (cured basal cell or squamous cell carcinoma of the skin allowed).

11) Subjects with evidence or history of serious or life-threatening allergic reactions to drugs.

12) Subjects with a history of drug (except nicotine) or alcohol abuse or dependence within the past 12 months.

13) Subjects with a positive urine drug screen for drugs of abuse/potential abuse not prescribed for the treatment of a medical condition.

14) Subjects with a body mass index (BMI) of less than 15 or greater than 38 when wearing indoor clothing without shoes. No subject will be enrolled with a weight less than 45.5 kg.

15) Subjects who have previously taken varenicline.

16) Subjects who participated previously in this trial or participated in any other studies involving investigational or marketed products, concomitantly or within 30 days (or 5 half-lives, whichever is longer) prior to entry into this study.

17) Subjects taking a concomitant medication that is prohibited by this protocol.

18) Subjects requiring other medications during the study that might interfere with the evaluation of the study drug.

19) Subjects who have used a nicotine replacement product, bupropion, clonidine, or nortriptyline for a quit attempt within the past 3 months, or have participated in a study with an experimental drug for smoking cessation within the past one year. Subjects who have recently used NRT for short intervals for management of craving and withdrawal during periods where smoking was prohibited (e.g., a plan trip) may be included.

20) Subjects who do not agree to completely abstain from using non-cigarette tobacco products (including, for example, pipe tobacco, cigars, snuff, nicotine replacement therapy, etc.) during study participation.

21) Subjects who donate blood or blood components while receiving study drug or within 1 month of the completion of the study treatment.

22) Subjects unable and/or unlikely to comprehend and follow the study protocol, including subjects unable and/or unwilling to participate in the non-treatment follow-up.

23) Subjects who in the investigator's opinion will be unlikely to commit to the study.

Links

Registration Number: NCT00691483
Study Information on Clinical Trials Registry (clinicaltrials.gov)