Human Laboratory Study of Varenicline and Bupropion for Nicotine Dependence

Nicotine Dependence Clinical Trial

— ChanBan  

Official title:

Human Laboratory Study of Varenicline and Bupropion for Nicotine Dependence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00749658
• Other study ID #: GCRC 10047
• Secondary ID: K01DA019446DPMC
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: November 2008
• Est. completion date: September 2010

Study information

• Verified date: October 2020
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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. -

Related Conditions & MeSH terms

• Nicotine Dependence
• Nicotine Withdrawal
• Tobacco Use Disorder

Intervention

Drug:
• Bupropion
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.

Locations

Country	Name	City	State
United States	University of Minnesota, Tobacco Use Research Center	Minneapolis	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
University of Minnesota	National Institute on Drug Abuse (NIDA), Pfizer

Country where clinical trial is conducted

United States, 

References & Publications (34)

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* Note: There are 34 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nicotine Withdrawal and Craving	Subjects were analyzed by how they self reported withdrawal or craved cigarettes during treatment Subjects self reported during study visits along with surveys	Change from Base line to 33 weeks

External Links

•   Tobacco Use Research Center