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Pharmacogenetics, Emotional Reactivity and Smoking

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00507728
First Posted: July 26, 2007
Last Update Posted: January 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
  Purpose
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.

Condition Intervention Phase
Tobacco Use Disorder Smoking Cessation Drug: Bupropion Drug: Varenicline Drug: Placebo Behavioral: Smoking Cessation Counseling Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Pharmacogenetics, Emotional Reactivity and Smoking

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Patient Emotional Reactivity During Smoking Cessation [ Time Frame: Baseline to 8 Months ]
    Emotional reactivity assessed by startle responding to positive and negative emotional cues.


Enrollment: 646
Actual Study Start Date: December 5, 2005
Estimated Study Completion Date: December 1, 2018
Estimated Primary Completion Date: December 1, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bupropion
Bupropion starting dose 150 mg by mouth daily (150 mg every morning for three days; 150 mg twice a day thereafter).
Drug: Bupropion
Starting dose 150 mg by mouth daily (150 mg every morning for three days; 150 mg twice a day thereafter)
Other Names:
  • Wellbutrin
  • Wellbutrin SR
  • Zyban
Behavioral: Smoking Cessation Counseling
Counseling over 8 months and telephone support calls.
Experimental: Varenicline
Varenicline starting dose 0.5 mg by mouth daily (0.5 mg every morning for days 1 - 3, then 0.5 mg twice a day for days 4 - 7, then 1 mg twice a day thereafter).
Drug: Varenicline
Starting dose 0.5 mg by mouth daily (0.5 mg every morning for days 1 - 3, then 0.5 mg twice a day for days 4 - 7, then 1 mg twice a day thereafter)
Other Name: Chantix
Behavioral: Smoking Cessation Counseling
Counseling over 8 months and telephone support calls.
Placebo Comparator: Placebo
Placebo by mouth for 12 weeks.
Drug: Placebo
Placebo by mouth for 12 weeks.
Behavioral: Smoking Cessation Counseling
Counseling over 8 months and telephone support calls.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00507728


Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Paul Cinciripini, PhD M.D. Anderson Cancer Center
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00507728     History of Changes
Other Study ID Numbers: 2003-1024
1R01DA017073 ( U.S. NIH Grant/Contract )
NCI-2012-02108 ( Registry Identifier: NCI CTRP )
First Submitted: July 25, 2007
First Posted: July 26, 2007
Last Update Posted: January 31, 2017
Last Verified: January 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Pharmacogenetics
Emotional Reactivity
Smoking Cessation Counseling
Smoking
Bupropion
Wellbutrin
Wellbutrin SR
Zyban
Varenicline
Chantix
Placebo

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Varenicline
Bupropion
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Agents
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors


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