Bupropion for Hospital-Based Smoking Cessation

NCT00261170 | Completed Phase 3

• 1 other identifier: 12RT-0148
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking

Keywords

smoking

Outcome Measures

Primary Outcomes (1)

• Smoking status at 6 months after enrollment

  6 months

Secondary Outcomes (1)

• smoking status at end of treatment

  7 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

bupropion and behavioral counseling

Drug: bupropion

2

PLACEBO COMPARATOR

placebo medication

Other: placebo

Interventions

bupropion DRUG

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

Also known as: Zyban

1

placebo OTHER

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

Also known as: sugar pill

2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

Veterans Affairs Medical Center

San Francisco, California, 94121, United States

Location

Related Publications (1)

• 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.

  PMID: 37230961 DERIVED

MeSH Terms

Conditions

Smoking

Interventions

Bupropion; Sugars

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Propiophenones; Ketones; Organic Chemicals; Carbohydrates

Study Officials

• Joel A Simon, MD, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 1, 2005
• First Posted: December 2, 2005
• Study Start: July 1, 2003
• Primary Completion: August 1, 2006
• Study Completion: February 1, 2007
• Last Updated: May 23, 2008

Record last verified: 2008-05

Locations

US (1)