Pharmacogenetics, Emotional Reactivity and Smoking

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Tobacco Use Disorder, Smoking Cessation

In brief

The goals of this placebo-controlled randomized clinical trial were to evaluate the differences in emotional reactivity (peak startle response to affective stimuli) during a cessation attempt among smokers treated with bupropion, varenicline, or placebo, and to determine if these differences were moderated by genotype.

Key facts

Study ID

NCT00507728

Run by

M.D. Anderson Cancer Center

People needed

646

Starts

2005-12-08

Expected to finish

2019-12-18

Last updated by the study team

2021-05-06

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age: 18-65 years old
• Smoking: >/= 5 cigarettes per day within the 2 months preceding the screening visit and expired CO greater than or equal to 6 ppm.
• Able to follow verbal and written instructions in English and complete all aspects of the study
• Have an address and home telephone number where they may be reached
• Provide informed consent and agree to all assessments and study procedures
• Be the only participant in their household

You may not qualify if…

• 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
• Within the month immediately preceding the screening visit; use of marijuana in any form on 3 or more days within a week
• Within the two weeks immediately preceding the screening visit, involvement on more than 3 days in any formal smoking cessation activities
• Current visual or auditory problems that in the opinion of the investigator would interfere with the completion of study assessments
• Treatment on a continuous basis within 2 weeks before the screening visit: any contraindicated medication for Varenicline or Bupropion.
• Uncontrolled hypertension or other major contraindications for Bupropion or Varenicline.
• Severe renal impairment (CR Clearance <30 ml/min/1.73 m2).
• Laboratory evaluations outside normal limits and of potential clinical significance in the opinion of the investigator
• 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.
• Subject rated as moderate to high on suicidality as assessed by the MINI.
• Psychiatric hospitalization within 1 year of screening date.
• 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.
• 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
• Use of Varenicline or Bupropion within two weeks before the screening visit.
• History of hypersensitivity or allergic reaction to Varenicline, tricyclic antidepressant, Bupropion (Wellbutrin, Zyban) or similar chemical classes or any component of these formulations.
• 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.

Where it is running

• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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