Human Laboratory Study of Varenicline and Bupropion for Nicotine Dependence

NCT00749658 | Completed Phase 2 Results DMC

• 3 other identifiers: GCRC 10047K01DA019446DPMC
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

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.

Conditions

Nicotine Dependence; Nicotine Withdrawal

Keywords

Tobacco; Nicotine; Smoking; Varenicline; Bupropion; Human laboratory study; Stress tolerance; Startle response; Cognitive assessment; Progressive ratio; Motivation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Bupropion + Placebo Varenicline

ACTIVE COMPARATOR

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

Drug: Bupropion; Drug: Varenicline

upropion + Varenicline

ACTIVE COMPARATOR

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

Drug: Bupropion; Drug: Varenicline

Interventions

Bupropion DRUG

Form: tablet, Dosage, Frequency, Duration: Days 1-3, 150 mg, q.d., Days 4-11, 150 mg, b.i.d.

Also known as: Zyban, Wellbutrin

Bupropion + Placebo Varenicline; upropion + Varenicline

Varenicline DRUG

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.

Also known as: Chantix

Bupropion + Placebo Varenicline; upropion + Varenicline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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).

Sponsors & Collaborators

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

Study Sites (1)

University of Minnesota, Tobacco Use Research Center

Minneapolis, Minnesota, 55414, United States

Location

Related Publications (34)

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Related Links

• Tobacco Use Research Center

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking

Interventions

Bupropion; Varenicline

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Propiophenones; Ketones; Organic Chemicals; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Results Point of Contact

• Title: Marc Mooney PhD
• Organization: University of Minnesota

moon0078@umn.edu

Study Officials

• Marc E Mooney, Ph.D.

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2008
• First Posted: September 9, 2008
• Study Start: November 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: November 23, 2020
• Results First Posted: November 23, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)