MDACC Study Summary 2008-0148

Study Summary
No. 2008-0148:.......Psychosocial......Jason D. Robinson......Behavioral Science

Study Summary Title



Study Summary Number:	2008-0148

Study Title:	The Effects of Smoking and Expectancy on ERP Measures of Attentional Bias

Physician

New Patient Referral



Name:	Jason D. Robinson	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:	Psychosocial	Supported By:	NIDA

Phase of Study:	N/A	Return Visit:	Participants will attend between 5 - 6 in-person visits: an Orientation and/or screening visit, and 4 laboratory sessions, each lasting between 1-3 hours in length depending on type of visit. All visits, will be separated by at least one day.

Treatment Agents:	None	Home Care:	None.

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	No hospitalization is required under this protocol.


Description/ Intervention:	The goal of this research study is to learn more about the way nicotine affects attention and emotions.

Study Objectives / Outcomes

This NIDA-funded study will be the first to evaluate the cognitive bias of smokers using a balanced placebo design (BPD), allowing us to separate the effects of drug from those of drug instruction and drug cues (i.e., the act of smoking). This study will seek to address the following specific aims and hypotheses:
1. To distinguish the effects of nicotine's pharmacological properties from those resulting from learned associations on the attentional distraction by smoking and affective cues in dependent smokers.
1.1. Deprived smokers Given-Nic should produce increased P3b to smoking and affective slides compared to when Given-Denic.
1.2. Deprived smokers Told-Nic should produce increased P3b to smoking and affective slides compared to when Told-Denic.
2. To determine whether gender differences exist in the attentional distraction by smoking and affective cues.
2.1. Women smokers, compared to men, are expected to show less differences in P3b attentional gating of salient smoking and affective cues due to nicotine dose.
3. To determine whether the expectation of imminent tobacco use increases the attentional distraction by smoking and affective cues.
3.1. Deprived smokers Told-Nic will demonstrate decreased P3b to smoking and affective slides compared to when Told-Denic, during the block prior to smoking.
4. To assess whether ERP measures of attentional distraction by smoking and affective cues correlate with traditional self-reported measures of nicotine dependence, craving, and affect.
4.1. ERP responses following smoking cues should modestly negatively correlate with self-reported craving.
Buccal samples will be collected at the separate Orientation session or at the combined Orientation/Screening Session in order to obtain genetic markers that have in the past been connected with nicotine dependence. As part of exploratory analyses, we will examine whether any of the genes related to neurotransmitter expression that are part of the nicotine pathway (e.g., CHRNA5, DRD2, 5-HTTLPR) are related to our measures of attentional distraction by smoking and affective cues.

Study Status Information



Study Activation / Registration Date:	06/17/2009

IRB Review and Approval Date:	07/09/2008

Study Type:	Behavioral

Recruitment Status:	Closed

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) Must be between the ages of 18 and 65.

2) Must smoke 10 or more cigarettes per day over the past month.

3) Must produce an expired carbon monoxide level greater than or equal to 6 ppm at the screening session.

4) Must possess fluency in spoken and written English as determined by the Rapid Estimate of Adult Literacy in Medicine (REALM).

5) Must agree to not use marijuana or other illicit drugs during the course of the study.

6) Must sign the Picture Consent Form.

7) Provide informed consent and agree to all assessments and study procedures.

Exclusion Criteria:

1) Taking psychotropic or narcotic medication.

2) Meets criteria for a current psychiatric disorder or reports current suicidal ideation as determined by the Patient's Health Questionnaire (PHQ).

3) Is involved in current or imminent smoking cessation activity.

4) Lacks a telephone.

5) Expresses interest in quitting within the next 45 days.

6) Fails to agree to comply with experimental procedures.

7) A woman who reports being pregnant, breast-feeding, or of childbearing potential who is not protected by a medically acceptable method of birth control while enrolled in the study.

8) Reports uncorrected visual acuity problems.

9) Must not have used marijuana or other illicit drugs within the week preceding screening.

10) Subject considered by the investigator as unsuitable or unstable candidate to be followed up throughout the entire duration of the study.

Links

Registration Number: Not Applicable Clinical Trial