Bupropion for Hospital-Based Smoking Cessation
Condition: Smoking
Study type: Interventional
Phase: Phase 3

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.
    

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.
    

Intervention name(s): bupropion; placebo
Intervention type(s): Drug; Other
Intervention description(s): 150 mg daily for the first 3 days, then 150 mg twice daily for 7 weeks; 1 pill daily for the first 3 days, then one pill twice daily for 7 weeks
Other intervention name(s): Zyban; sugar pill
Intervention MeSH terms: Bupropion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: smoking