The Effect of Varenicline (Chantix) and Bupropion (Zyban) on Smoking Lapse Behavior
This study is ongoing, but not recruiting participants.
Sponsor:
Yale University
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Sherry McKee, Yale University
ClinicalTrials.gov Identifier:
NCT00580853
First received: December 25, 2007
Last updated: May 6, 2016
Last verified: May 2016
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to examine how smoking cessation medications (varenicline, bupropion) affect the ability to resist smoking and also subsequent ad-lib smoking in non-treatment seeking daily smokers.
| Condition | Intervention | Phase |
|---|---|---|
|
Smoking Lapse Behavior |
Drug: varenicline Drug: bupropion Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | The Effect of Varenicline (Chantix) and Bupropion (Zyban) on Smoking Lapse Behavior |
Resource links provided by NLM:
Further study details as provided by Yale University:
Primary Outcome Measures:
- latency to initiate ad-lib smoking session [ Time Frame: in the laboratory session ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- number of cigarettes smoked during the ad-lib period [ Time Frame: during the laboratory session ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 60 |
| Study Start Date: | April 2007 |
| Estimated Study Completion Date: | July 2016 |
| Estimated Primary Completion Date: | July 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: varenicline
varenicline 2mg/day
|
Drug: varenicline
2mg/day, with 1-week lead-in medication period The starting dose is 0.5 mg/day for days 1-2, followed by 0.5mg twice daily for days 3-5 and then 1mg twice daily for days 4-7. 1mg administered during laboratory session (day 8).
Other Name: Chantix
|
|
Experimental: Bupropion
Bupropion 300mg/day
|
Drug: bupropion
300mg/day, with 1-week lead-in medication period The starting dose is 150mg/day for days 1-3, 300mg/day for days 4-7. 300mg administered during laboratory session (day 8).
Other Name: Zyban
|
|
Placebo Comparator: Placebo
Placebo Control
|
Drug: Placebo
Placebo
|
Eligibility| Ages Eligible for Study: | 21 Years to 55 Years (Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- ages 18-55
- able to read and write in English
- Smokers
Exclusion Criteria:
- any significant current medical or psychiatric conditions that would contraindicate smoking
- current DSM-IV abuse or dependence of other substances, other than nicotine dependence or alcohol abuse
- positive test result at intake appointments on urine drug screens conducted for opiates, cocaine, or benzodiazepines
- women who are pregnant or nursing
- suicidal, homicidal, or evidence of current severe mental illness
- participants prescribed any psychotropic drug in the 30 days prior to study enrollment
- blood donation within the past 6 weeks
- individuals seeking treatment for smoking cessation or have attempted to quit smoking within the past 3 months
- specific exclusions for bupropion administration not already specified, including: have taken monoamine inhibitors in the past 6 weeks; history of anorexia or bulimia; previous hypersensitivity to bupropion; history of alcohol or drug dependence in the past year; history of seizure disorder of any etiology
- known allergy to varenicline or taking H2blockers
- participation within the past 8 weeks in other studies that involve additive blood sampling and/or interventional measures that would be considered excessive in combination with the current study
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00580853
Please refer to this study by its ClinicalTrials.gov identifier: NCT00580853
Locations
| United States, Connecticut | |
| Yale Center for Clinical Investigation, Yale University | |
| New Haven, Connecticut, United States, 06519 | |
Sponsors and Collaborators
Yale University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
| Principal Investigator: | Sherry A McKee, PhD | Yale University |
More Information
| Responsible Party: | Sherry McKee, Associate Professor of Psychiatry, Yale University |
| ClinicalTrials.gov Identifier: | NCT00580853 History of Changes |
| Other Study ID Numbers: | HIC0702002390 P50AA015632 |
| Study First Received: | December 25, 2007 |
| Last Updated: | May 6, 2016 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Yale University:
|
smoking lapse behavior smoking cessation varenicline bupropion medication effect on smoking lapse behavior |
Additional relevant MeSH terms:
|
Varenicline Bupropion Nicotinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Antidepressive Agents, Second-Generation |
Antidepressive Agents Psychotropic Drugs Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Dopamine Agents Cytochrome P-450 CYP2D6 Inhibitors Cytochrome P-450 Enzyme Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on September 27, 2016