Status:
COMPLETED
Human Laboratory Study of Varenicline and Bupropion for Nicotine Dependence
Lead Sponsor:
University of Minnesota
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Pfizer
Conditions:
Nicotine Dependence
Nicotine Withdrawal
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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...
Eligibility Criteria
Inclusion
- 18 years and up.
- Smoked at least 10 cigarettes/day for at least 1 year.
- English speaking and reading.
- Females who are of childbearing potential must practice effective contraception and meet the following criteria:
- Are instructed to avoid pregnancy through 30 days after the last dose of study medication.
- Have a negative urine pregnancy test at baseline.
- 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.
- Willingness to not use illicit drugs during study period including marijuana.
Exclusion
- Any unstable medical condition.
- Unstable angina, myocardial infarction, or coronary angioplasty within the past 3 months or an untreated cardiac dysrhythmia.
- Personal history of seizures.
- Closed head trauma with any loss of consciousness or amnesia in the last 5 years.
- 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.
- A history of psychosis, bipolar disorder, bulimia or anorexia nervosa.
- Current depression as assessed by Center for Epidemiologic Studies Depression Scale (CES-D).
- 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.
- Active substance abuse other than nicotine.
- Used an investigational drug within the last 30 days.
- Are currently using a behavioral or pharmacologic tobacco treatment.
- Use of bupropion or varenicline in the previous 30 days.
- Current (past 14 days) use of antipsychotic or antidepressant medications.
- An allergy to bupropion or varenicline.
- Untreated hypertension or baseline systolic blood pressure \> 180 or diastolic \> 100.
- Impaired kidney function (creatinine clearance \< 30).
- Having plans to leave the immediate geographical area within 2 months.
- Unwillingness or inability to give written informed consent.
- \-
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT00749658
Start Date
November 1 2008
End Date
September 1 2010
Last Update
November 23 2020
Active Locations (1)
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1
University of Minnesota, Tobacco Use Research Center
Minneapolis, Minnesota, United States, 55414