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
  Purpose

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.


Condition Intervention Phase
Nicotine Dependence
Nicotine Withdrawal
Drug: Bupropion SR
Drug: Varenicline
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Human Laboratory Study of Varenicline and Bupropion for Nicotine Dependence

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Medication side effects [ Time Frame: All visits ] [ Designated as safety issue: Yes ]

Enrollment: 10
Study Start Date: November 2008
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Order 1: Bupropion + Placebo Varenicline \Varenicline + Placebo Bupropion; Order 2: Varenicline + Placebo Bupropion \Bupropion + Placebo Varenicline
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: 2
Order 1: Bupropion + Varenicline \Varenicline + Placebo Bupropion; Order 2: Varenicline + Placebo Bupropion \Bupropion + Varenicline
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: 3
Order 1: Bupropion + Varenicline \Bupropion + Placebo Varenicline; Order 2: Bupropion+ Placebo Varenicline \Bupropion + Varenicline
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.

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  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: NCT00749658

Locations
United States, Minnesota
University of Minnesota, Tobacco Use Research Center
Minneapolis, Minnesota, United States, 55414
Sponsors and Collaborators
Pfizer
Investigators
Principal Investigator: Marc E Mooney, Ph.D. University of Minnesota - Clinical and Translational Science Institute
  More Information

Additional Information:
Publications:

Responsible Party: Marc E. Mooney, Ph.D./Assistant Professor of Psychiatry, University of Minnesota
ClinicalTrials.gov Identifier: NCT00749658     History of Changes
Other Study ID Numbers: GCRC 10047, K01DA019446, DPMC
Study First Received: September 5, 2008
Last Updated: July 9, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institute on Drug Abuse (NIDA):
Tobacco
Nicotine
Smoking
Varenicline
Bupropion
Human laboratory study
Stress tolerance
Startle response
Cognitive assessment
Progressive ratio
Motivation

Additional relevant MeSH terms:
Tobacco Use Disorder
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Bupropion
Nicotine
Varenicline
Antidepressive Agents
Antidepressive Agents, Second-Generation
Autonomic Agents
Central Nervous System Agents
Cholinergic Agents
Cholinergic Agonists
Dopamine Agents
Dopamine Uptake Inhibitors
Ganglionic Stimulants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Nicotinic Agonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014