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ChanBan: Human Laboratory Study of Varenicline and Bupropion for Nicotine Dependence

Sponsor
University of Minnesota (Other)
Overall Status
Completed
CT.gov ID
NCT00749658
Collaborator
National Institute on Drug Abuse (NIDA) (NIH), Pfizer (Industry)
121
Enrollment
1
Location
2
Arms
22
Duration (Months)
5.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
121 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Human Laboratory Study of Varenicline and Bupropion for Nicotine Dependence
Study Start Date :
Nov 1, 2008
Actual Primary Completion Date :
Sep 1, 2010
Actual Study Completion Date :
Sep 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Bupropion + Placebo Varenicline

Bupropion + Placebo Varenicline \Varenicline + Placebo Bupropion; Varenicline + Placebo Bupropion \Bupropion + Placebo Varenicline

Drug: Bupropion
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 Names:
  • Chantix

    		•
    Active Comparator: upropion + Varenicline

    Bupropion + Varenicline \Varenicline + Placebo Bupropion; Varenicline + Placebo Bupropion \Bupropion + Varenicline

    Drug: Bupropion
    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 Names:
  • Chantix

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Nicotine Withdrawal and Craving [Change from Base line to 33 weeks]

      Subjects were analyzed by how they self reported withdrawal or craved cigarettes during treatment Subjects self reported during study visits along with surveys

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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:

    5. Are instructed to avoid pregnancy through 30 days after the last dose of study medication.

    6. Have a negative urine pregnancy test at baseline.

    7. 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.

    8. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Minnesota, Tobacco Use Research Center Minneapolis Minnesota United States 55414

    Sponsors and Collaborators

    • University of Minnesota
    • National Institute on Drug Abuse (NIDA)
    • Pfizer

    Investigators

    • Principal Investigator: Marc E Mooney, Ph.D., University of Minnesota

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    University of Minnesota
    ClinicalTrials.gov Identifier:
    NCT00749658
    Other Study ID Numbers:
    • GCRC 10047
    • K01DA019446
    • DPMC
    First Posted:
    Sep 9, 2008
    Last Update Posted:
    Nov 23, 2020
    Last Verified:
    Oct 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by University of Minnesota
    Tobacco
    Nicotine
    Smoking
    Varenicline
    Bupropion
    Human laboratory study
    Stress tolerance
    Startle response
    Cognitive assessment
    Progressive ratio
    Motivation
    Additional relevant MeSH terms:
    Tobacco Use Disorder
    Bupropion
    Varenicline

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Bupropion + Placebo Varenicline Varenicline + Placebo Bupropion
    Arm/Group Description Order 1: Bupropion + Placebo Varenicline \Varenicline + Placebo Bupropion; Order 2: Varenicline + Placebo Bupropion \Bupropion + Placebo Varenicline Bupropion SR: Form: tablet, Dosage, Frequency, Duration: Days 1-3, 150 mg, q.d., Days 4-11, 150 mg, b.i.d. 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. Order 1: Bupropion + Varenicline \Varenicline + Placebo Bupropion; Order 2: Varenicline + Placebo Bupropion \Bupropion + Varenicline Bupropion SR: Form: tablet, Dosage, Frequency, Duration: Days 1-3, 150 mg, q.d., Days 4-11, 150 mg, b.i.d. 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.
    Period Title: Overall Study
    STARTED 60 61
    COMPLETED 60 61
    NOT COMPLETED 0 0

    Baseline Characteristics

    Arm/Group Title Bupropion + Placebo Varenicline Upropion + Varenicline Total
    Arm/Group Description Order 1: Bupropion + Placebo Varenicline \Varenicline + Placebo Bupropion; Order 2: Varenicline + Placebo Bupropion \Bupropion + Placebo Varenicline Bupropion SR: Form: tablet, Dosage, Frequency, Duration: Days 1-3, 150 mg, q.d., Days 4-11, 150 mg, b.i.d. 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. Order 1: Bupropion + Varenicline \Varenicline + Placebo Bupropion; Order 2: Varenicline + Placebo Bupropion \Bupropion + Varenicline Bupropion SR: Form: tablet, Dosage, Frequency, Duration: Days 1-3, 150 mg, q.d., Days 4-11, 150 mg, b.i.d. 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. Total of all reporting groups
    Overall Participants 60 61 121
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    39.5
    (11.2)
    40.2
    (11.3)
    39.85
    (11.25)
    Sex: Female, Male (Count of Participants)
    Female
    30
    50%
    30
    49.2%
    60
    49.6%
    Male
    30
    50%
    31
    50.8%
    61
    50.4%
    Race/Ethnicity, Customized (Count of particpants) [Number]
    White
    56
    52
    108
    Region of Enrollment (participants) [Number]
    United States
    60
    100%
    61
    100%
    121
    100%

    Outcome Measures

    1. Primary Outcome
    Title Nicotine Withdrawal and Craving
    Description Subjects were analyzed by how they self reported withdrawal or craved cigarettes during treatment Subjects self reported during study visits along with surveys
    Time Frame Change from Base line to 33 weeks

    Outcome Measure Data

    Analysis Population Description
    All efforts were made to contact the PI/study team members, but were unsuccessful. No outcome measure study data are available.
    Arm/Group Title Bupropion + Placebo Varenicline Varenicline + Placebo Bupropion
    Arm/Group Description Order 1: Bupropion + Placebo Varenicline \Varenicline + Placebo Bupropion; Order 2: Varenicline + Placebo Bupropion \Bupropion + Placebo Varenicline Bupropion SR: Form: tablet, Dosage, Frequency, Duration: Days 1-3, 150 mg, q.d., Days 4-11, 150 mg, b.i.d. 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. Order 1: Bupropion + Varenicline \Varenicline + Placebo Bupropion; Order 2: Varenicline + Placebo Bupropion \Bupropion + Varenicline Bupropion SR: Form: tablet, Dosage, Frequency, Duration: Days 1-3, 150 mg, q.d., Days 4-11, 150 mg, b.i.d. 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.
    Measure Participants 0 0
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Bupropion + Placebo Varenicline, Varenicline + Placebo Bupropion
    Comments
    Type of Statistical Test Other
    Comments Two tailed testing
    Statistical Test of Hypothesis p-Value 0.07
    Comments
    Method SAS
    Comments

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title Bupropion + Placebo Varenicline Varenicline + Placebo Bupropion
    Arm/Group Description Order 1: Bupropion + Placebo Varenicline \Varenicline + Placebo Bupropion; Order 2: Varenicline + Placebo Bupropion \Bupropion + Placebo Varenicline Bupropion SR: Form: tablet, Dosage, Frequency, Duration: Days 1-3, 150 mg, q.d., Days 4-11, 150 mg, b.i.d. 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. Order 1: Bupropion + Varenicline \Varenicline + Placebo Bupropion; Order 2: Varenicline + Placebo Bupropion \Bupropion + Varenicline Bupropion SR: Form: tablet, Dosage, Frequency, Duration: Days 1-3, 150 mg, q.d., Days 4-11, 150 mg, b.i.d. 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.
    All Cause Mortality
    Bupropion + Placebo Varenicline Varenicline + Placebo Bupropion
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Bupropion + Placebo Varenicline Varenicline + Placebo Bupropion
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/60 (0%) 0/61 (0%)
    Other (Not Including Serious) Adverse Events
    Bupropion + Placebo Varenicline Varenicline + Placebo Bupropion
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/60 (0%) 0/61 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Marc Mooney PhD
    Organization University of Minnesota
    Phone
    Email moon0078@umn.edu
    Responsible Party:
    University of Minnesota
    ClinicalTrials.gov Identifier:
    NCT00749658
    Other Study ID Numbers:
    • GCRC 10047
    • K01DA019446
    • DPMC
    First Posted:
    Sep 9, 2008
    Last Update Posted:
    Nov 23, 2020
    Last Verified:
    Oct 1, 2020