Human Laboratory Study of Varenicline and Bupropion for Nicotine Dependence (ChanBan)

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00749658
First received: September 5, 2008
Last updated: July 9, 2012
Last verified: October 2010

September 5, 2008
July 9, 2012
November 2008
September 2010   (final data collection date for primary outcome measure)
  • Nicotine withdrawal and craving [ Time Frame: All visits ] [ Designated as safety issue: No ]
  • Attention and concentration [ Time Frame: 3 human laboratory visits ] [ Designated as safety issue: No ]
  • Psychophysiology [ Time Frame: 2 human laboratory visits ] [ Designated as safety issue: No ]
  • Stress Tolerance [ Time Frame: 2 human laboratory visits ] [ Designated as safety issue: No ]
  • Motivation to smoke [ Time Frame: 2 human laboratory visits ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00749658 on ClinicalTrials.gov Archive Site
Medication side effects [ Time Frame: All visits ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Human Laboratory Study of Varenicline and Bupropion for Nicotine Dependence
Human Laboratory Study of Varenicline and Bupropion for Nicotine Dependence

The objective of this proposal is to elucidate effects of bupropion SR + varenicline on smoking-cessation related processes in early abstinence using a human laboratory model. A within-subjects design will be used to assess the additive effects of bupropion and varenicline in 48 treatment seeking smokers [bupropion SR (300 mg/day)+placebo, varenicline (2 mg/day+placebo, and bupropion SR (300 mg/day)+varenicline (2 mg/day)]. Outcomes include withdrawal and craving, cognition, stress tolerance, anxiety, the reinforcing effects of smoking, and smoking topography.

Hypotheses: We hypothesize that greatest treatment effects will be observed in the bupropion SR+varenicline group followed by varenicline+placebo and bupropion SR+placebo groups.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Nicotine Dependence
  • Nicotine Withdrawal
  • Drug: Bupropion SR
    Form: tablet, Dosage, Frequency, Duration: Days 1-3, 150 mg, q.d., Days 4-11, 150 mg, b.i.d.
    Other Names:
    • Zyban
    • Wellbutrin
  • Drug: Varenicline
    Form: tablet, Dosage, Frequency, Duration: Days 1-3, .5 mg, q.d., Days 4-7, .5 mg, b.i.d., Days 8-11, 1 mg, b.i.d.
    Other Name: Chantix
  • Active Comparator: 1
    Order 1: Bupropion + Placebo Varenicline \Varenicline + Placebo Bupropion; Order 2: Varenicline + Placebo Bupropion \Bupropion + Placebo Varenicline
    Interventions:
    • Drug: Bupropion SR
    • Drug: Varenicline
  • Active Comparator: 2
    Order 1: Bupropion + Varenicline \Varenicline + Placebo Bupropion; Order 2: Varenicline + Placebo Bupropion \Bupropion + Varenicline
    Interventions:
    • Drug: Bupropion SR
    • Drug: Varenicline
  • Active Comparator: 3
    Order 1: Bupropion + Varenicline \Bupropion + Placebo Varenicline; Order 2: Bupropion+ Placebo Varenicline \Bupropion + Varenicline
    Interventions:
    • Drug: Bupropion SR
    • Drug: Varenicline

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
September 2010
September 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. 18 years and up.
  2. Smoked at least 10 cigarettes/day for at least 1 year.
  3. English speaking and reading.
  4. Females who are of childbearing potential must practice effective contraception and meet the following criteria:

    1. Are instructed to avoid pregnancy through 30 days after the last dose of study medication.
    2. Have a negative urine pregnancy test at baseline.
    3. Agree to use of the birth control methods listed: an oral contraceptive agent, an intrauterine device (IUD), an implantable contraceptive (e.g., Norplant), or an injectable contraceptive (e.g., Depo-Provera) for at least one month prior to entering the study and will continue its use through at least 30 days after the last dose of the study medication. A barrier method of contraception (e.g., condom or diaphragm with spermicide) while participating in the study and 30 days after the last dose of study medication.
  5. Willingness to not use illicit drugs during study period including marijuana.

Exclusion Criteria:

  1. Any unstable medical condition.
  2. Unstable angina, myocardial infarction, or coronary angioplasty within the past 3 months or an untreated cardiac dysrhythmia.
  3. Personal history of seizures.
  4. Closed head trauma with any loss of consciousness or amnesia in the last 5 years.
  5. A history of closed head trauma with > 30 minutes of loss of consciousness or amnesia or resulting in skull fracture or subdural hematoma/brain contusion.
  6. A history of psychosis, bipolar disorder, bulimia or anorexia nervosa.
  7. Current depression as assessed by Center for Epidemiologic Studies Depression Scale (CES-D).
  8. Medications that might affect the outcome measures of nicotine reward, cognition, anxiety, and stress will also be a basis for exclusion. These medications include psychotropic drugs (i.e., anti-psychotic, anti-depressant, anti-anxiety, or stimulant), anti- hypertensive agents (e.g., beta-blockers), and other drugs that can influence the outcome domains.
  9. Active substance abuse other than nicotine.
  10. Used an investigational drug within the last 30 days.
  11. Are currently using a behavioral or pharmacologic tobacco treatment.
  12. Use of bupropion or varenicline in the previous 30 days.
  13. Current (past 14 days) use of antipsychotic or antidepressant medications.
  14. An allergy to bupropion or varenicline.
  15. Untreated hypertension or baseline systolic blood pressure > 180 or diastolic > 100.
  16. Impaired kidney function (creatinine clearance < 30).
  17. Having plans to leave the immediate geographical area within 2 months.
  18. Unwillingness or inability to give written informed consent.

    -

Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00749658
GCRC 10047, K01DA019446, DPMC
Yes
Marc E. Mooney, Ph.D./Assistant Professor of Psychiatry, University of Minnesota
National Institute on Drug Abuse (NIDA)
Pfizer
Principal Investigator: Marc E Mooney, Ph.D. University of Minnesota - Clinical and Translational Science Institute
National Institute on Drug Abuse (NIDA)
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP