MDACC Study Summary 2006-0304 (Archived)

Study Summary
No. 2006-0304:.......Cancer Prevention......Paul Cinciripini......Behavioral Science

Study Summary Title



Study Summary Number:	2006-0304

Study Title:	An international, seven-week, double-blind, placebo-controlled, two parallel group study to assess the efficacy of Dianicline 40 mg bid as an aid to smoking cessation in cigarette smokers. (EFC-5514)

Physician

New Patient Referral



Name:	Paul Cinciripini	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:	N/A

Phase of Study:	Phase III	Return Visit:	Fifteen outpatient visits, each approximately one to two hours in duration.

Treatment Agents:	Behavioral Intervention Dianicline Placebo	Home Care:	N/A

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	Unavailable

Study Objectives / Outcomes

The primary study objective is to demonstrate the efficacy of Dianicline 40 mg bid versus placebo as an aid to smoking cessation in cigarette smokers, after seven weeks of treatment. The secondary objectives are to assess: 1) nicotine craving with the Questionnaire of Smoking Urges (QSU-brief scale), 2) nicotine withdrawal symptoms with the Hughes Hatsukami Minnesota Withdrawal Scale (MNWS) during the first 3 weeks of treatment, 3) weekly point prevalence rate of abstinence during the treatment period, (i.e. segment B), 4) the number of smoke-free days, average number of cigarettes smoked during segment B, 5) the clinical and biological safety and tolerability of Dianicline during segment B, and the first week of segment C, and 6) the abstinence rate after a 19-week follow-up post-treatment period at six months from the Target Quit Date (TQD).

Study Status Information



Study Activation / Registration Date:	09/27/2006

IRB Review and Approval Date:	05/17/2006

Study Type:	Phase Iii

Recruitment Status:	Terminated

Projected Accrual:	600

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) Outpatients over legal age, smoking at least 10 cigarettes/day as a mean within the 2 months preceding the screening visit.

Exclusion Criteria:

1) Refusal or inability to give informed consent to participate in the study.

2) Level of motivation to quit less than 6 on the ten-point Likert Scale.

3) Not able to follow verbal and written instructions and to complete all aspects of the study.

4) Other participant in a household enrolled in the study.

5) Patients who have taken an investigational drug within the past six months prior to the screening visit.

6) Patients who had a previous quit attempt (>/= 1 day, with the aid of a pharmacological adjunct) in the previous three months (before screening).

7) Patients who have smoked or consumed non-tobacco cigarettes or any form of tobacco product (other than cigarettes such as cigars, pipes, smokeless tobacco, etc) more than 3 times within the 3 months preceding the screening visit.

8) Patients who currently present with (based on DSM-IV): － Psychotic Disorder － Major Depressive Episode

9) Pregnant or breast-feeding women.

10) Women of childbearing potential not protected by effective contraceptive method of birth control and/or who are unwilling or unable to be tested for pregnancy. Medically acceptable methods of birth control for this study include approved hormonal contraceptive medications or devices, approved intra-uterine contraceptive devices, use of two combined barrier methods.

11) Patients who have suffered from a myocardial infarction, unstable angina or other major cardiovascular event within the past week prior to screening.

12) Patients who have a history of multiple allergic reactions to medications in two drug classes.

13) Patients who have QTcF greater than or equal to 500 ms on the ECG.

14) Patients with mild, moderate or severe renal impairment defined as: -Creatinine clearance < 80 mL/min.

15) Patients who have an abnormal laboratory test of potential clinical significance at screening: - AST or ALT levels > 2 X ULN (Upper Limit of Normal range for the laboratory).

Links

Registration Number: NCT00387946
Study Information on Clinical Trials Registry (clinicaltrials.gov)