Bupropion for Hospital-Based Smoking Cessation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00261170
Recruitment Status : Completed
First Posted : December 2, 2005
Last Update Posted : May 23, 2008
Information provided by:
University of California, San Francisco

Brief Summary:
This is a randomized blinded trial of whether hospitalized smokers who are randomly assigned to receive bupropion, an antidepressant, and cognitive-behavioral counseling, are more likely to have quit smoking at the end of treatment and at 6 months compared with smokers randomly assigned to receive placebo and cognitive-behavioral counseling. Because depression is more prevalent among smokers and because smokers who are prone to depression may become depressed when they quit, the hypothesis is that the proportion of quitters who receive the active drug/antidepressant will be greater than the proportion of quitters who receive the placebo drug at 6 months.

Condition or disease Intervention/treatment Phase
Smoking Drug: bupropion Other: placebo Phase 3

Detailed Description:

Two hundred and seventy patients will be enrolled;approximately 135 will be randomized to each study arm over the course of 24 months. Patients will be considered smokers if they have used tobacco products during the week prior to admission and if they have smoked> or = 5 cigarettes /day during the previous year.Smokers will be identified by review of admissions and given a flyer to invite them to join the study. Interested smokers will be screened and asked to fill out a Beck Depression Inventory. Patients with very high Beck Depression Inventory Scores, i.e. > or = 30, will not be enrolled because such individuals may require other treatment. Each patient's physician will be contacted to verify his/her eligibility for the study. Once eligibility has been ascertained, a research associate will visit the patient to obtain informed consent and to enroll them in the study. Study questionnaires and a Fagerstrom test for Nicotine Dependence will be completed and reviewed by a research associate for completeness at the time of enrollment. The associate will put in the prescription for the study drug and request the order for dispensing of the drug. The research pharmacist will randomize the patient to Study Arm 1 or Study Arm 2.

Subjects randomized to Study Arm 1 will receive a standard 7-week course of sustained release bupropion (150 mg/day for the first 3 days, then 150mg BID), a self-help booklet, counseling on smoking cessation strategies, and follow-up phone counseling during the first 3 months after randomization. Study Arm 2 participants will receive the same intervention as Study Arm 1, but will receive placebo instead of active bupropion therapy. Both study groups will complete study questionnaires regarding their medical and smoking history and will be followed one week after their hospital discharge to record their blood pressure and to monitor possible side effects.

Since quit rates tend to decline over time, relapse prevention approaches will be included in both study arms. Marlatt's theory of relapse, an extension of Bandura's social learning model, will be used to augment the quitter's perception of self-efficacy. Participants will be trained to resist and cope with the temptations and stresses likely to be encountered after discharge from the hospital. Behavioral self-management techniques to counter known relapse-triggers such as stress, the presence of other smokers, alcohol use and depression will be discussed during follow-up counseling calls.

We will measure saliva cotinine in all participants who give a history of smoking abstinence at the end of treatment and at 6 months. Cotinine levels of > or + 15 ng/mL will be considered evidence of current tobacco use. Participants who are self-reported quitters, but have failed to provide a saliva sample will be considered as smokers unless verification from a spouse or significant other can be obtained. Participants who have died will be analyzed as smokers or quitters based on prior self-report, information in medical records, or interviews with next-of-kin. Others will be censored (i.e. excluded from the analysis). All cotinine samples will be assayed at the University of California, San Francisco,laboratory of Dr. Neal Benowitz.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Bupropion for Hospital-Based Smoking Cessation
Study Start Date : July 2003
Actual Primary Completion Date : August 2006
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
bupropion and behavioral counseling
Drug: bupropion
150 mg daily for the first 3 days, then 150 mg twice daily for 7 weeks
Other Name: Zyban
Placebo Comparator: 2
placebo medication
Other: placebo
1 pill daily for the first 3 days, then one pill twice daily for 7 weeks
Other Name: sugar pill

Primary Outcome Measures :
  1. Smoking status at 6 months after enrollment [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. smoking status at end of treatment [ Time Frame: 7 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • currently smoking - use of tobacco products during the week prior to hospital admission and having smoked at least 5 cigarettes /day during the past year
  • eligibility to receive medical care in a VA hospital
  • hospitalization for at least 48 hours to provide sufficient time to identify, screen, enroll and counsel participants
  • willingness to participate and give informed consent

Exclusion Criteria:

  • hospitalization for acute CHD syndromes
  • contraindications to the use of bupropion
  • family history of seizure disorder, history of severe head trauma, predisposition to seizures
  • unstable psychiatric disorder
  • pregnancy, lactation
  • current alcohol (defined as greater than 3 drinks/day) or drug abuse (defined as current/within last 3 months use of narcotics, heroin, cocaine, amphetamines)
  • current untreated depression (BDI score > or = 30)
  • terminal illness
  • inability to be contacted by phone

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00261170

United States, California
Veterans Affairs Medical Center
San Francisco, California, United States, 94121
Sponsors and Collaborators
University of California, San Francisco
Principal Investigator: Joel A Simon, MD, MPH University of California, San Francisco

Responsible Party: Joan Kaiser, Contracts & Grants, University of California Office of the President Special Research Programs Identifier: NCT00261170     History of Changes
Other Study ID Numbers: 12RT-0148
First Posted: December 2, 2005    Key Record Dates
Last Update Posted: May 23, 2008
Last Verified: May 2008

Keywords provided by University of California, San Francisco:

Additional relevant MeSH terms:
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors