Pharmacogenetics, Emotional Reactivity and Smoking

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00507728
First received: July 25, 2007
Last updated: January 27, 2014
Last verified: January 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 375
Study Start Date: December 2005
Estimated Primary Completion Date: December 2015 (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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00507728

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Paul Cinciripini, PhD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided by M.D. Anderson Cancer Center

Additional 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
Study First Received: July 25, 2007
Last Updated: January 27, 2014
Health Authority: United States: Institutional Review Board

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
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Bupropion
Varenicline
Antidepressive Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Cholinergic Agents
Cholinergic Agonists
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Nicotinic Agonists
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014