Nicotine DependencePhase 2/3ChanBanNCT00749658
Human Laboratory Study of Varenicline and Bupropion for Nicotine Dependence
A Phase 2/3 study testing Bupropion and Varenicline in people with Nicotine Dependence and Nicotine Withdrawal, run by University of Minnesota at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence, Nicotine Withdrawal
- What is being tested?
- Bupropion and Varenicline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Sep 2010
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 19Show fewer
- 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.
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota, Tobacco Use Research Center
Minneapolis, Minnesota, 55414
About this study
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
- Being tested
- Bupropion, Varenicline
- Keywords
- Tobacco, Nicotine, Smoking, Varenicline, Bupropion, Human laboratory study, Stress tolerance, Startle response, Cognitive assessment, Progressive ratio, Motivation
- Medical subject headings
- Tobacco Use Disorder, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupropionDrug
Also called Zyban, Wellbutrin
Form: tablet, Dosage, Frequency, Duration: Days 1-3, 150 mg, q.d., Days 4-11, 150 mg, b.i.d.
VareniclineDrug
Also called Chantix
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.
| Study group | Role | What they receive |
|---|---|---|
| Bupropion + Placebo Varenicline | Active comparator | Bupropion + Placebo Varenicline \Varenicline + Placebo Bupropion; Varenicline + Placebo Bupropion \Bupropion + Placebo Varenicline Receives: Drug: Bupropion; Drug: Varenicline |
| upropion + Varenicline | Active comparator | Bupropion + Varenicline \Varenicline + Placebo Bupropion; Varenicline + Placebo Bupropion \Bupropion + Varenicline Receives: Drug: Bupropion; Drug: Varenicline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change from Base line to 33 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2008 (estimated)
- Study startNov 2008
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Pfizer
- Responsible party
- Sponsor
- Investigators
- Marc E Mooney, Ph.D., Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00749658
- Sponsor's protocol ID
- GCRC 10047
- Other IDs
- K01DA019446, DPMC
- Acronym
- ChanBan
- Status last verified
- Oct 2020
- First submitted
- 5 Sep 2008
- Last updated
- 23 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Ingersoll KS, Cohen J. Combination treatment for nicotine dependence: state of the science. Subst Use Misuse. 2005;40(13-14):1923-43, 2043-8. doi: 10.1080/10826080500294817.
PubMed 16282086Sweeney CT, Fant RV, Fagerstrom KO, McGovern JF, Henningfield JE. Combination nicotine replacement therapy for smoking cessation: rationale, efficacy and tolerability. CNS Drugs. 2001;15(6):453-67. doi: 10.2165/00023210-200115060-00004.
PubMed 11524024Biberman R, Neumann R, Katzir I, Gerber Y. A randomized controlled trial of oral selegiline plus nicotine skin patch compared with placebo plus nicotine skin patch for smoking cessation. Addiction. 2003 Oct;98(10):1403-7. doi: 10.1046/j.1360-0443.2003.00524.x.
PubMed 14519177Bohadana A, Nilsson F, Rasmussen T, Martinet Y. Nicotine inhaler and nicotine patch as a combination therapy for smoking cessation: a randomized, double-blind, placebo-controlled trial. Arch Intern Med. 2000 Nov 13;160(20):3128-34. doi: 10.1001/archinte.160.20.3128.
PubMed 11074742Cinciripini PM, Tsoh JY, Wetter DW, Lam C, de Moor C, Cinciripini L, Baile W, Anderson C, Minna JD. Combined effects of venlafaxine, nicotine replacement, and brief counseling on smoking cessation. Exp Clin Psychopharmacol. 2005 Nov;13(4):282-92. doi: 10.1037/1064-1297.13.4.282.
PubMed 16366758Croghan GA, Sloan JA, Croghan IT, Novotny P, Hurt RD, DeKrey WL, Mailliard JA, Ebbert LP, Swan DK, Walsh DJ, Wiesenfeld M, Levitt R, Stella P, Johnson PA, Tschetter LK, Loprinzi C. Comparison of nicotine patch alone versus nicotine nasal spray alone versus a combination for treating smokers: a minimal intervention, randomized multicenter trial in a nonspecialized setting. Nicotine Tob Res. 2003 Apr;5(2):181-7. doi: 10.1080/1462220031000073252.
PubMed 12745490Croghan IT, Hurt RD, Dakhil SR, Croghan GA, Sloan JA, Novotny PJ, Rowland KM, Bernath A, Loots ML, Le-Lindqwister NA, Tschetter LK, Garneau SC, Flynn KA, Ebbert LP, Wender DB, Loprinzi CL. Randomized comparison of a nicotine inhaler and bupropion for smoking cessation and relapse prevention. Mayo Clin Proc. 2007 Feb;82(2):186-95. doi: 10.4065/82.2.186.
PubMed 17290726Evins AE, Cather C, Culhane MA, Birnbaum A, Horowitz J, Hsieh E, Freudenreich O, Henderson DC, Schoenfeld DA, Rigotti NA, Goff DC. A 12-week double-blind, placebo-controlled study of bupropion sr added to high-dose dual nicotine replacement therapy for smoking cessation or reduction in schizophrenia. J Clin Psychopharmacol. 2007 Aug;27(4):380-6. doi: 10.1097/01.jcp.0b013e3180ca86fa.
PubMed 17632223Fagerstrom KO, Tonnesen P. Nicotine chewing gum and nicotine patch. Wien Med Wochenschr. 1995;145(4):77-82.
PubMed 7778323Hall SM, Humfleet GL, Reus VI, Munoz RF, Cullen J. Extended nortriptyline and psychological treatment for cigarette smoking. Am J Psychiatry. 2004 Nov;161(11):2100-7. doi: 10.1176/appi.ajp.161.11.2100.
PubMed 15514412Jorenby DE, Leischow SJ, Nides MA, Rennard SI, Johnston JA, Hughes AR, Smith SS, Muramoto ML, Daughton DM, Doan K, Fiore MC, Baker TB. A controlled trial of sustained-release bupropion, a nicotine patch, or both for smoking cessation. N Engl J Med. 1999 Mar 4;340(9):685-91. doi: 10.1056/NEJM199903043400903.
PubMed 10053177Killen JD, Fortmann SP, Schatzberg AF, Hayward C, Sussman L, Rothman M, Strausberg L, Varady A. Nicotine patch and paroxetine for smoking cessation. J Consult Clin Psychol. 2000 Oct;68(5):883-9.
PubMed 11068974Killen JD, Robinson TN, Ammerman S, Hayward C, Rogers J, Stone C, Samuels D, Levin SK, Green S, Schatzberg AF. Randomized clinical trial of the efficacy of bupropion combined with nicotine patch in the treatment of adolescent smokers. J Consult Clin Psychol. 2004 Aug;72(4):729-35. doi: 10.1037/0022-006X.72.4.729.
PubMed 15301658Kornitzer M, Boutsen M, Dramaix M, Thijs J, Gustavsson G. Combined use of nicotine patch and gum in smoking cessation: a placebo-controlled clinical trial. Prev Med. 1995 Jan;24(1):41-7. doi: 10.1006/pmed.1995.1006.
PubMed 7740014Krishnan-Sarin S, Meandzija B, O'Malley S. Naltrexone and nicotine patch smoking cessation: a preliminary study. Nicotine Tob Res. 2003 Dec;5(6):851-7. doi: 10.1080/14622200310001614601.
PubMed 14750508
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Laboratory Study of Varenicline and Bupropion for Nicotine Dependence
- ClinicalTrials.gov ID
- NCT00749658
- Acronym / sponsor ID
- ChanBan / GCRC 10047
- Conditions
- Nicotine Dependence, Nicotine Withdrawal
- Keywords
- Tobacco, Nicotine, Smoking, Varenicline, Bupropion, Human laboratory study, Stress tolerance, Startle response
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Pfizer
- Study start
- Nov 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 9 Sep 2008 (estimated)
- Results
- Posted 23 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupropion + Placebo Varenicline | Active comparator | Drug: Bupropion, Drug: VareniclineBupropion + Placebo Varenicline \Varenicline + Placebo Bupropion; Varenicline + Placebo Bupropion \Bupropion + Placebo Varenicline |
| upropion + Varenicline | Active comparator | Drug: Bupropion, Drug: VareniclineBupropion + Varenicline \Varenicline + Placebo Bupropion; Varenicline + Placebo Bupropion \Bupropion + Varenicline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- Willingness to not use illicit drugs during study period including marijuana.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BupropionAlso: Zyban, WellbutrinForm: tablet, Dosage, Frequency, Duration: Days 1-3, 150 mg, q.d., Days 4-11, 150 mg, b.i.d. | Drug | Bupropion + Placebo Varenicline, upropion + Varenicline |
| VareniclineAlso: ChantixForm: 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. | Drug | Bupropion + Placebo Varenicline, upropion + Varenicline |
Primary outcome
Nicotine Withdrawal and Craving
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16282086Ingersoll KS, Cohen J. Combination treatment for nicotine dependence: state of the science. Subst Use Misuse. 2005;40(13-14):1923-43, 2043-8. doi: 10.1080/10826080500294817.
- Background: PubMed 11524024Sweeney CT, Fant RV, Fagerstrom KO, McGovern JF, Henningfield JE. Combination nicotine replacement therapy for smoking cessation: rationale, efficacy and tolerability. CNS Drugs. 2001;15(6):453-67. doi: 10.2165/00023210-200115060-00004.
- Background: PubMed 14519177Biberman R, Neumann R, Katzir I, Gerber Y. A randomized controlled trial of oral selegiline plus nicotine skin patch compared with placebo plus nicotine skin patch for smoking cessation. Addiction. 2003 Oct;98(10):1403-7. doi: 10.1046/j.1360-0443.2003.00524.x.
- Background: PubMed 11074742Bohadana A, Nilsson F, Rasmussen T, Martinet Y. Nicotine inhaler and nicotine patch as a combination therapy for smoking cessation: a randomized, double-blind, placebo-controlled trial. Arch Intern Med. 2000 Nov 13;160(20):3128-34. doi: 10.1001/archinte.160.20.3128.
- Background: PubMed 16366758Cinciripini PM, Tsoh JY, Wetter DW, Lam C, de Moor C, Cinciripini L, Baile W, Anderson C, Minna JD. Combined effects of venlafaxine, nicotine replacement, and brief counseling on smoking cessation. Exp Clin Psychopharmacol. 2005 Nov;13(4):282-92. doi: 10.1037/1064-1297.13.4.282.
- Background: PubMed 12745490Croghan GA, Sloan JA, Croghan IT, Novotny P, Hurt RD, DeKrey WL, Mailliard JA, Ebbert LP, Swan DK, Walsh DJ, Wiesenfeld M, Levitt R, Stella P, Johnson PA, Tschetter LK, Loprinzi C. Comparison of nicotine patch alone versus nicotine nasal spray alone versus a combination for treating smokers: a minimal intervention, randomized multicenter trial in a nonspecialized setting. Nicotine Tob Res. 2003 Apr;5(2):181-7. doi: 10.1080/1462220031000073252.
- Background: PubMed 17290726Croghan IT, Hurt RD, Dakhil SR, Croghan GA, Sloan JA, Novotny PJ, Rowland KM, Bernath A, Loots ML, Le-Lindqwister NA, Tschetter LK, Garneau SC, Flynn KA, Ebbert LP, Wender DB, Loprinzi CL. Randomized comparison of a nicotine inhaler and bupropion for smoking cessation and relapse prevention. Mayo Clin Proc. 2007 Feb;82(2):186-95. doi: 10.4065/82.2.186.
- Background: PubMed 17632223Evins AE, Cather C, Culhane MA, Birnbaum A, Horowitz J, Hsieh E, Freudenreich O, Henderson DC, Schoenfeld DA, Rigotti NA, Goff DC. A 12-week double-blind, placebo-controlled study of bupropion sr added to high-dose dual nicotine replacement therapy for smoking cessation or reduction in schizophrenia. J Clin Psychopharmacol. 2007 Aug;27(4):380-6. doi: 10.1097/01.jcp.0b013e3180ca86fa.
- Background: PubMed 7778323Fagerstrom KO, Tonnesen P. Nicotine chewing gum and nicotine patch. Wien Med Wochenschr. 1995;145(4):77-82.
- Background: PubMed 15514412Hall SM, Humfleet GL, Reus VI, Munoz RF, Cullen J. Extended nortriptyline and psychological treatment for cigarette smoking. Am J Psychiatry. 2004 Nov;161(11):2100-7. doi: 10.1176/appi.ajp.161.11.2100.
- Background: PubMed 10053177Jorenby DE, Leischow SJ, Nides MA, Rennard SI, Johnston JA, Hughes AR, Smith SS, Muramoto ML, Daughton DM, Doan K, Fiore MC, Baker TB. A controlled trial of sustained-release bupropion, a nicotine patch, or both for smoking cessation. N Engl J Med. 1999 Mar 4;340(9):685-91. doi: 10.1056/NEJM199903043400903.
- Background: PubMed 11068974Killen JD, Fortmann SP, Schatzberg AF, Hayward C, Sussman L, Rothman M, Strausberg L, Varady A. Nicotine patch and paroxetine for smoking cessation. J Consult Clin Psychol. 2000 Oct;68(5):883-9.
- Tobacco Use Research CenterLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc E Mooney, Ph.D. principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Bupropion and Varenicline in people with Nicotine Dependence and Nicotine Withdrawal, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nicotine Withdrawal and Craving (time frame: Change from Base line to 33 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00749658, which also lists 34 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2020.