Human Laboratory Study of Varenicline and Bupropion for Nicotine Dependence

NCT00749658

Last updated date
Study Location
University of Minnesota, Tobacco Use Research Center
Minneapolis, Minnesota, 55414, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Nicotine Dependence, Nicotine Withdrawal
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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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Nicotine Dependence, Nicotine WithdrawalHuman Laboratory Study of Varenicline and Bupropion for Nicotine Dependence
NCT00749658
  1. Minneapolis, Minnesota
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Human Laboratory Study of Varenicline and Bupropion for Nicotine Dependence
Official Title  ICMJE Human Laboratory Study of Varenicline and Bupropion for Nicotine Dependence
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Nicotine Dependence
  • Nicotine Withdrawal
Intervention  ICMJE
  • 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 Name: Chantix
Study Arms  ICMJE
  • Active Comparator: Bupropion + Placebo Varenicline
    Bupropion + Placebo Varenicline \Varenicline + Placebo Bupropion; Varenicline + Placebo Bupropion \Bupropion + Placebo Varenicline
    Interventions:
    • Drug: Bupropion
    • Drug: Varenicline
  • Active Comparator: upropion + Varenicline
    Bupropion + Varenicline \Varenicline + Placebo Bupropion; Varenicline + Placebo Bupropion \Bupropion + Varenicline
    Interventions:
    • Drug: Bupropion
    • Drug: Varenicline
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 30, 2020)
121
Original Estimated Enrollment  ICMJE
 (submitted: September 5, 2008)
48
Actual Study Completion Date  ICMJE September 2010
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

    -

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00749658
Other Study ID Numbers  ICMJE GCRC 10047
K01DA019446 ( U.S. NIH Grant/Contract )
DPMC ( Other Identifier: NIDA )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party University of Minnesota
Study Sponsor  ICMJE University of Minnesota
Collaborators  ICMJE
  • National Institute on Drug Abuse (NIDA)
  • Pfizer
Investigators  ICMJE
Principal Investigator:Marc E Mooney, Ph.D.University of Minnesota
PRS Account University of Minnesota
Verification Date October 2020

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