MDACC Study Summary 2003-1024

Study Summary
No. 2003-1024:.......Cancer Prevention......Paul Cinciripini......Behavioral Science

Study Summary Title



Study Summary Number:	2003-1024

Study Title:	Pharmacogenetics, Emotional Reactivity & Smoking

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 II/Phase III	Return Visit:	9 outpatient visits, 3 approximately three to four hours in duration; the other six approximately one to two hours in duration.

Treatment Agents:	Behavioral Intervention Bupropion Varenicline	Home Care:	Five telephone support calls will be provided over the span of the program.

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	N/A

Description/
Intervention:

The goal of this behavioral research study is to learn more about how the drugs
Bupropion and Varenicline affect mood and physiological responses in different
groups of people as they attempt to quit smoking. Researchers want to learn
how these drugs affect responses related to changes in emotion and whether or
not a person's genetic make-up makes a difference in how they respond to the
medication.

Study Objectives / Outcomes

Recent advances in smoking cessation have focused on the use of Varenicline and antidepressants (e.g., Bupropion) for the treatment of nicotine dependence. While the efficacy of these treatments has been established in previous studies, we know little about how they work. The specific aims of this project are to assess the effects of these drugs on changes in emotional reactivity during cessation, to determine if these effects are moderated by genotype, and to determine whether emotional reactivity predicts time to relapse. A standardized laboratory assessment procedure, known as the acoustic startle probe, will be used to assess emotional reactivity. In this study, 375 smokers will be randomly assigned to receive Bupropion, Varenicline or placebo. Participants will complete three startle assessments consisting of the presentation of an acoustic stimulus (startle probe), immediately preceded by positive, negative or neutral emotional cues or smoking related stimuli. We hypothesize that the emotional reactivity of all smokers during cessation will be significantly less for those treated with either Varenicline or Bupropion in comparison to placebo. It is also hypothesized that emotional reactivity will be lower for those carrying the DRD2 A1 allele and using Varenicline vs. A1 smokers using either Bupropion or placebo. Homozygous A2s are expected to respond similarly to both drugs with higher levels of emotional reactivity being observed for placebo. We will also characterize other potential markers for neurotransmitter function (DRD4, DAT, SERT, NET) in terms of differences in both baseline emotional reactivity, and response to pharmacotherapy vs. the control. We hope to understand more fully how pharmacotherapies for smoking cessation affect emotional reactivity during cessation (nicotine withdrawal) and what role genetics may play in conferring an advantage to one treatment vs. another, through this mechanism.

Study Status Information



Study Activation / Registration Date:	12/08/2005

IRB Review and Approval Date:	03/12/2004

Study Type:

Recruitment Status:	Open

Projected Accrual:	N/A

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) Age: 18-65 years old

2) Smoking: >/= 5 cigarettes per day within the 2 months preceding the screening visit and expired CO greater than or equal to 6 ppm.

3) Able to follow verbal and written instructions in English and complete all aspects of the study

4) Have an address and home telephone number where they may be reached

5) Provide informed consent and agree to all assessments and study procedures

6) Be the only participant in their household

Exclusion Criteria:

1) Within the month immediately preceding the screening visit; use of any form of tobacco product other than cigarettes on 3 or more days within a week only if the individual refuses to refrain from non-cigarette tobacco use during the course of this study

2) Within the month immediately preceding the screening visit; use of marijuana in any form on 3 or more days within a week

3) Within the two weeks immediately preceding the screening visit, involvement on more than 3 days in any formal smoking cessation activities

4) Current visual or auditory problems that in the opinion of the investigator would interfere with the completion of study assessments

5) Treatment on a continuous basis within 2 weeks before the screening visit: any contraindicated medication for Varenicline or Bupropion.

6) Uncontrolled hypertension or other major contraindications for Bupropion or Varenicline.

7) Severe renal impairment (CR Clearance <30 ml/min/1.73 m2).

8) Laboratory evaluations outside normal limits and of potential clinical significance in the opinion of the investigator

9) Meet current criteria for psychiatric disorders or substance abuse as assessed by the MINI for items A, B, D, I, J, K, L, M and N, including a past manic or hypomanic episode as well as a lifetime psychotic disorder.

10) Subject rated as moderate to high on suicidality as assessed by the MINI.

11) Psychiatric hospitalization within 1 year of screening date.

12) A positive urine pregnancy test during the screening period. Women who are two years post menopausal, one year post-tubal ligation, or who have had a partial or full hysterectomy will not be subject to a urine pregnancy test.

13) Pregnant, breast-feeding, or of childbearing potential who is not protected by a medically acceptable, effective method of birth control while enrolled in the study

14) Use of Varenicline or Bupropion within two weeks before the screening visit.

15) History of hypersensitivity or allergic reaction to Varenicline, tricyclic antidepressant, Bupropion (Wellbutrin, Zyban) or similar chemical classes or any component of these formulations.

16) Subject considered by the investigator as unsuitable candidate for receipt of an investigational drug, or unstable to be followed up throughout the entire duration of the study.

Links

Registration Number: NCT00507728
Study Information on Clinical Trials Registry (clinicaltrials.gov)