Bupropion for Hospital-Based Smoking Cessation

NCT ID: NCT00261170

Last Updated: 2008-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-07-31
• Study Completion Date: 2007-02-28

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.

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.

Conditions

Smoking

Keywords

smoking

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

bupropion and behavioral counseling

Group Type: ACTIVE_COMPARATOR

bupropion

Intervention Type: DRUG

150 mg daily for the first 3 days, then 150 mg twice daily for 7 weeks

2

placebo medication

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

1 pill daily for the first 3 days, then one pill twice daily for 7 weeks

Interventions

bupropion

150 mg daily for the first 3 days, then 150 mg twice daily for 7 weeks

Intervention Type: DRUG

placebo

1 pill daily for the first 3 days, then one pill twice daily for 7 weeks

Intervention Type: OTHER

Other Intervention Names

Zyban; sugar pill

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

University of California Office of the President Special Research Programs

Principal Investigators

Joel A Simon, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

Veterans Affairs Medical Center

San Francisco, California, United States

Countries

United States

References

Hajizadeh A, Howes S, Theodoulou A, Klemperer E, Hartmann-Boyce J, Livingstone-Banks J, Lindson N. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2023 May 24;5(5):CD000031. doi: 10.1002/14651858.CD000031.pub6.

Reference Type: DERIVED

PMID: 37230961 (View on PubMed)

Other Identifiers

12RT-0148

Identifier Type: -

Identifier Source: secondary_id

12RT-0148

Identifier Type: -

Identifier Source: org_study_id